Clinical Study to Examine Brushing on Dental Implants

Gingival Diseases Clinical Trial

Official title:

Clinical Study to Examine Brushing on Dental Implants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00762619
• Other study ID #: CRO-2007-IMPLANT-PS
• Status: Completed
• Phase: Phase 3
• First received: September 26, 2008
• Last updated: January 4, 2011
• Start date: April 2007
• Est. completion date: August 2008

Study information

• Verified date: January 2011
• Source: Colgate Palmolive
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The efficacy of two dentifrices in controlling gingivitis and plaque in adults with implants

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 76 Years

Eligibility

Inclusion Criteria:

• Males and females in good oral and general health aged 18 to 76 years.

• A willingness to read, understand, and sign the Informed Consent Form after the nature of the study has been fully explained to them. Subject should demonstrate willingness to comply with all study procedures and availability for duration of study.

• Subjects will use the provided test articles and discontinue the use of other dentifrices and mouthrinses for the duration of the study.

• A minimum of 20 natural teeth with facial and lingual scorable surfaces. Teeth that are grossly carious, fully crowned or extensively restored on facial and/or lingual surfaces, orthodontically banded, abutments, or third molars will not be included in the tooth count.

• Adequate oral hygiene and no signs of oral neglect.

• Subjects will have at least one dental implant and a contralateral natural tooth.

• At the first visit subjects will be examined by a dentist for periodontal health.

• Selected subjects will have periodontal pockets less than 6mm.

• Subjects with gingival index equal to or greater than 1.0 and plaque index equal to or greater than or 1. 5 on the implant tooth will be enrolled. Gingival and plaque indices will be measured during the first visit for the implant. Similarly, these clinical indices (Gingival and plaque index) will be determined for the contralateral natural tooth. (The adjacent teeth will serve as a backup for the studies if control tooth is lost during study).

• Subjects who are habitual users of Colgate Total or other oral hygiene formulations with antimicrobial agents will complete a washout phase of 30 days with a commercial fluoride dentifrice prior to enrollment in the study. This washout dentifrice will be identified and obtained by the clinical investigator from an appropriate local source.

Exclusion Criteria:

• History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses. Allergy to personal care/consumer products or their ingredients.

• Regular use of mouthwash with antimicrobial agents within the past month.

• History of diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases, e.g. heart disease or AIDS.

• History of hepatitis, rheumatic fever, pacemaker, or prosthetic heart valves, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.

• Subjects presenting significant medical conditions or need for long term drug therapy.

• Subjects on antibiotic, anti inflammatory or anticoagulant therapy during the month preceding the baseline exam.

• Significant oral soft tissue pathology, systemically related gingival enlargement, severe gingivitis (based on a visual examinations) that would interfere with the study.

• History of active severe periodontal disease with bleeding gums and loose teeth.

• Widespread caries or chronic neglect. Subjects presenting with gross dental caries, severe generalized cervical abrasion and/or enamel abrasion, and large fractured or temporary restorations (based on visual examinations).

• Fixed or removable orthodontic appliance or removable partial dentures.

• Participation in any clinical study including dental plaque/gingivitis clinical trial involving oral care products, within the last 30 days. History of dental prophylaxis or treatments in the month preceding the start of study.

• Self reported pregnancy or lactation.

• History or current use of objects to pierce the lips or tongue.

• Subjects known to be an alcoholic, or a recovering alcoholic.

• History or current use of recreational drugs or narcotics.

• Determine smoking status of subjects and exclude current smokers.

• Determine reason for placing implants in subject to exclude subjects whose implants were placed for trauma.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Diseases
• Periodontal Diseases

Intervention

Drug:
• Fluoride
Brush twice daily
• Triclosan, fluoride
Brush twice daily

Locations

Country	Name	City	State
Israel	The Hebrew University-Hadassah	Jerusalem
United States	State University of New York at Buffalo	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Colgate Palmolive

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mombelli Plaque Index (mPI) for Natural Teeth	Modified Plaque Index (mPI)is a Dental plaque scale as follows 0 = No plaque,; 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth.	3 months	No
Primary	Mombelli Plaque Index (mPI) for Natural Teeth	Modified Plaque Index (mPI) is a Dental plaque scale as follows 0 = No plaque,; 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth.	6 months	No
Primary	Mombelli Plaque Index (mPI) for Dental Implants	Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque,; 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth.	3 months	No
Primary	Mombelli Plaque Index (mPI) for Dental Implants	Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque,; 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth.	6 months	No
Primary	Löe-Silness Gingival Index Score (GI) - Natural Teeth	Gingivitis score(GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score = adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.	3 months	No
Primary	Löe-Silness Gingival Index Score (GI) - Natural Teeth	Gingivitis score(GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding.Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score = adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.	6 months	No
Primary	Löe-Silness Gingival Index Score (GI)- Dental Implants	Gingivitis Score (GI) is defined: 0 = Absence of inflammation,1=Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score=adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.	3 months	No
Primary	Löe-Silness Gingival Index Score (GI)- Dental Implants	Gingivitis Score (GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score=adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.	6 months	No
Primary	Gingival Bleeding on Probing (BOP) Using Sulcus Bleeding Index for Teeth	Sulcus bleeding index for teeth is explained here. Gums around teeth are scored:0 = gingiva of normal texture & color, no bleeding;1 = gingiva normal, bleeds on probing;2 = bleeding on probing,change in color, no oedema; 3 = bleeding on probing,change in color, slight oedema;4 = bleeding on probing, change in color, obvious oedema;5=bleeding on probing, spontaneous bleeding, change in color, marked oedema.	3 months	No
Primary	Gingival Bleeding on Probing (BOP) Using Sulcus Bleeding Index for Teeth	Sulcus bleeding index for teeth is explained here. Gums around teeth are scored:0 = gingiva of normal texture & color, no bleeding;1 = gingiva normal, bleeds on probing;2 = bleeding on probing,change in color, no oedema;3 = bleeding on probing,change in color, slight oedema;4 = bleeding on probing,change in color, obvious oedema;5 = bleeding on probing, spontaneous bleeding,change in color,marked oedema.	6 months	No
Primary	Gingival Bleeding on Probing (BOP) Using the Modified Sulcus Bleeding Index for Implants	Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding.	3 months	No
Primary	Gingival Bleeding on Probing (BOP) Using the Modified Sulcus Bleeding Index for Implants	Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding.	6 months	No
Primary	A.Actinomycetemcomitans (DNA Probe Analysis) - Natural Teeth	14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are Least means square (LSM)determined by baseline adjusted means including Standard Error of means (SEM).	3 months	No
Primary	A.Actinomycetemcomitans (DNA Probe Analysis)- Natural Teeth	14 microorganisms were identified via DNA probe analysis for natural teeth. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM).	6 months	No
Primary	A.Actinomycetemcomitans (DNA Probe Analysis)- Dental Implant	14 microorganisms were identified via DNA probe analysis for Dental Implant. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM).	3 months	No
Primary	A.Actinomycetemcomitans (DNA Probe Analysis)- Dental Implant	14 microorganisms were identified via DNA probe analysis for Dental Implant. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM).	6 months	No
Primary	C.Rectus (DNA Probe Analysis) - Natural Teeth	14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).	3 months	No
Primary	C.Rectus (DNA Probe Analysis) - Natural Teeth	14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).	6 months	No
Primary	C.Rectus (DNA Probe Analysis) - Dental Implant	14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).	3 months	No
Primary	C.Rectus (DNA Probe Analysis) - Dental Implant	14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).	6 months	No
Primary	Capnocytophaga sp. (DNA Probe Analysis) - Natural Teeth	14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).	3 months	No
Primary	Capnocytophaga sp. (DNA Probe Analysis) - Natural Teeth	14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).	6 months	No
Primary	Capnocytophaga sp. (DNA Probe Analysis) - Dental Implant	14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).	3 months	No
Primary	Capnocytophaga sp. (DNA Probe Analysis) - Dental Implant	14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).	6 months	No
Primary	E.Corrodens (DNA Probe Analysis) - Natural Teeth	14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).	3 months	No
Primary	E.Corrodens (DNA Probe Analysis) - Natural Teeth	14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).	6 months	No
Primary	E.Corrodens (DNA Probe Analysis) - Dental Implant	14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).	3 months	No
Primary	E.Corrodens (DNA Probe Analysis) - Dental Implant	14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).	6 months	No
Primary	E.Saburreum (DNA Probe Analysis) - Natural Teeth	14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).	3 months	No
Primary	E.Saburreum (DNA Probe Analysis)- Natural Teeth	14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)detemined by using baseline adjusted means including standard error of means (SEM).	6 months	No
Primary	E.Saburreum (DNA Probe Analysis) - Dental Implant	14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).	3 months	No
Primary	E.Saburreum (DNA Probe Analysis) - Dental Implant	14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).	6 months	No
Primary	F.Nucleatum (DNA Probe Analysis) - Natural Teeth	14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM).	3 months	No
Primary	F.Nucleatum (DNA Probe Analysis) - Natural Teeth	14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)	6 months	No
Primary	F.Nucleatum (DNA Probe Analysis) - Dental Implants	14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM).	3 months	No
Primary	F.Nucleatum (DNA Probe Analysis) - Dental Implants	14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM).	6 months	No
Primary	Neissera sp. (DNA Probe Analysis) - Natural Teeth	14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).	3 months	No
Primary	Neissera sp. (DNA Probe Analysis) Natural Teeth	14 microorganisms were identified via DNA probe analysis for natural teeth. Data points least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).	6 months	No
Primary	Neissera sp. (DNA Probe Analysis) - Dental Implants	14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).	3 months	No
Primary	Neissera sp. (DNA Probe Analysis) - Dental Implants	14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).	6 months	No
Primary	P.Gingivalis (DNA Probe Analysis) - Natural Teeth	14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)	3 months	No
Primary	P.Gingivalis (DNA Probe Analysis) - Natural Teeth	14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM)	6 months	No
Primary	P.Gingivalis (DNA Probe Analysis) - Dental Implants	14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)	3 months	No
Primary	P.Gingivalis (DNA Probe Analysis) - Dental Implants	14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)	6 months	No
Primary	P.Intermedia (DNA Probe Analysis) - Natural Teeth	14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).	3 months	No
Primary	P.Intermedia (DNA Probe Analysis) - Natural Teeth	14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).	6 months	No
Primary	P.Intermedia (DNA Probe Analysis) - Dental Implants	14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).	3 months	No
Primary	P.Intermedia (DNA Probe Analysis) - Dental Implants	14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).	6 months	No
Primary	P.Melaninogenica (DNA Probe Analysis) - Natural Teeth	14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).	3 months	No
Primary	P.Melaninogenica (DNA Probe Analysis) - Natural Teeth	14 microorganisms were identified via DNA probe analysis for both natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).	6 months	No
Primary	P.Melaninogenica (DNA Probe Analysis) - Dental Implants	14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).	3 months	No
Primary	P.Melaninogenica (DNA Probe Analysis) - Dental Implants	14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).	6 months	No
Primary	Solobacterium (S.Moorei)(DNA Probe Analysis) - Natural Teeth	14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).	3 months	No
Primary	Solobacterium (S.Moorei)(DNA Probe Analysis) - Natural Teeth	14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error (SEM).	6 months	No
Primary	Solobacterium (S.Moorei)(DNA Probe Analysis) - Dental Implants	14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).	3 months	No
Primary	Solobacterium (S.Moorei)(DNA Probe Analysis) - Dental Implants	14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).	6 months	No
Primary	Streptococci (DNA Probe Analysis) - Natural Teeth	14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM).	3 months	No
Primary	Streptococci (DNA Probe Analysis) - Natural Teeth	14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).	6 months	No
Primary	Streptococci (DNA Probe Analysis) - Dental Implants	14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM).	3 months	No
Primary	Streptococci (DNA Probe Analysis) - Dental Implants	14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM).	6 months	No
Primary	T.Forsythia (DNA Probe Analysis)- Natural Teeth	14 microorganisms were identified via DNA probe analysis for both natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).	3 months	No
Primary	T.Forsythia (DNA Probe Analysis)-Natural Teeth	14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).	6 months	No
Primary	T.Forsythia (DNA Probe Analysis)- Dental Implants	14 microorganisms were identified via DNA probe analysis for both Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).	3 months	No
Primary	T.Forsythia (DNA Probe Analysis)- Dental Implants	14 microorganisms were identified via DNA probe analysis for both Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).	6 months	No
Primary	Veillonella sp.(DNA Probe Analysis) - Natural Teeth	14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM)	3 months	No
Primary	Veillonella sp.(DNA Probe Analysis) - Natural Teeth	14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error (SEM).	6 months	No
Primary	Veillonella sp.(DNA Probe Analysis) - Dental Implants	14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM)	3 months	No
Primary	Veillonella sp.(DNA Probe Analysis) - Dental Implants	14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM)	6 months	No