Clinical Effects of Tooth Powder on Gingivitis

Gingivitis Clinical Trial

— Toothpowder  

Official title:

Evaluation of the Clinical Effects of Tooth Powder on Plaque Induced Gingivitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01902095
• Other study ID #: KhanMK-2012
• Status: Completed
• Phase: Phase 2
• First received: May 9, 2013
• Last updated: July 17, 2013
• Start date: November 2010
• Est. completion date: October 2011

Study information

• Verified date: May 2013
• Source: Sheikh Zayed Federal Postgraduate Medical Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Dental plaque, known as dental biofilm, is implicated as the primary etiological agent responsible for oral inflammatory diseases. Matured form of dental plaque plays a major role in the pathogenicity of gingivitis; if not managed in early stages it results in a cascade of events leading to the destruction of periodontal tissues.

Effective plaque control techniques have been suggested that maintain dental biofilm at levels compatible with oral health and is the cornerstone for all preventive strategies to control oral diseases particularly gingivitis. To clean teeth and ensure effective plaque control, different mechanical means have been in use since centuries. However because of an inadequacy in plaque removal, different antimicrobial and antiplaque agents have been introduced in oral-care products.

The use of dentifrices has been recommended over the years as the ultimate way of preventing the incidence of oral diseases. Dentifrices have the anti-plaque and the anti-gingivitis capabilities due to their composition. Toothpastes and to a lesser extent toothpowders are common oral-care products used to eliminate plaque and other deposits from tooth surfaces. Existent literature has focused more on toothpaste and mouth rinse and derelicts toothpowder despite its difference owing to the absence of humectants. With the intention to advance the knowledge on this issue as well as close the research gap, this study was conducted to evaluate the efficacy of toothpowder in alleviating gingivitis, controlling dental plaque, and inhibiting extrinsic stains.

A single-blind, parallel arm randomized controlled trial (RCT) evaluated the efficacy of toothpowder against toothpaste through oral hygiene parameters of plaque and stain deposits on teeth and gingival inflammation. Plaque Index, Lobene Stain Index and Gingival Index were used as measures of oral hygiene.

The current RCT revealed that toothpowder and toothpaste were equally effective in both treatment and control groups from clinical perspective however toothpowder showed a statistically significant effectiveness as compared to toothpaste. Toothpowder, composed of calcium carbonate and essential oils, has demonstrated to be statistically more effective than toothpaste in controlling extrinsic dental staining, dental plaque and gingival inflammation.

Description:

A single-blind randomized controlled trial was conducted during November 2010 and October 2011. After screening and consent, eligible subjects received mechanical periodontal therapy. Subjects were then randomized to Test group and Control group at a 1:1 ratio. The test group was provided tooth powder and a control group received toothpaste. Healthy subjects with plaque induced gingivitis and who fulfilled the inclusion criteria were recruited from the Department of Periodontology, Fatima Jinnah Dental College Hospital, Karachi, Pakistan.77 subjects with gingivitis were randomized to test group and 77 subjects to the control group. Therefore, to complete the randomized controlled trial, a total of 154 subjects were recruited and randomized.

Outcome measure gingivitis was measured through plaque index, gingival index and Lobene stain index.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: October 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 33 Years to 40 Years

Eligibility

1. Inclusion Criteria

1. Male or female

2. Age = 18-to-65 years (18th birthday completed)

3. In good general health

4. Available for the duration of the study

5. Able and willing to follow study protocol

6. Able and willing to sign approved informed consent

7. At least 20 natural teeth suitable for evaluation

8. Full mouth Gingival Index (GI) score = 1.04

2. Exclusion Criteria

1. Females disagree to birth control measure for the duration of the study

2. Having any acute /chronic systemic illness

3. Current smokers or tobacco users

4. Pregnant or lactating Females

5. Allergy to the ingredients of the products to be tested

6. Requiring pre-medication prior to dental appointment

7. Antibiotic use in the last 3 months

8. Routine use of anticoagulant medication

9. Routine use of anti-inflammatory medication

10. Routine use of medications known to have effects on the gingiva e.g., phenytoin etc)

11. Routine use of medications inhibiting or stimulating salivary flow

12. Physical handicap that could interfere with daily performance of oral hygiene

13. Participation in any other study during the study period of this trial

14. Routine use of any mouthrinse

15. Routine use of any interdental cleaning device (floss, dental toothpicks)

16. Having any removable appliance

17. Having fixed orthodontic appliances (including permanent orthodontic retainers)

18. Having probing depth =4 mm at any site

19. Having had active periodontal therapy during the last 6 months

20. Had periodontal prophylaxis or periodontal maintenance therapy in the last 3 months

21. More than 3 carious lesions requiring immediate care

22. Gross oral pathology (e.g., tumors, candidiasis, mucocutaneous disease)

Related Conditions & MeSH terms

• Gingivitis
• Mouth Diseases

Intervention

Device:
• Tooth powder
Each participant was handed over a sealed pack containing a teeth cleaning kit that included tooth powder (test) or toothpaste (control) and a new soft toothbrush along with written and verbal instructions of usage. They were advised to brush their teeth twice a day with the given dentifrices and tooth brush for two weeks.
• Tooth paste (control)
Active Comparator

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sheikh Zayed Federal Postgraduate Medical Institute	Fatima Jinnah Dental College

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gingivitis	Gingival Index (Löe and Silness, 1963) modified by Talbott et al. (1977) was used for the assessment of the gingival condition and record qualitative changes in the gingiva. Its scores (0 to 3) recorded the marginal and interproximal tissues separately. The criteria are: 0= normal gingiva, 1= mild inflammation - slight change in color and slight edema but no bleeding on probing, 2= moderate inflammation - redness, edema and glazing, bleeding on probing and 3= severe inflammation - marked redness and edema, ulceration with a tendency to spontaneous bleeding.	November 2010 - October 2011 (up to 1 year)
Secondary	Plaque	Quigley-Hein (Tuersky) Index was used for plaque deposits. This index is based on the visually check of non-restored surface of all the teeth except third molars; this is done on a scale from score 0 to score 5. An index for the entire mouth is determined by dividing the total score by the number surfaces examined. The criteria for scoring are: 0 = no plaque, 1 = separate flecks of plaque, 2 = continuous band of 1 mm, 3 = >1mm and <1/3 of tooth surface, 4 = >1/3 and <2/3 and 5 = >2/3 of tooth covered with plaque	November 2010 - October 2011 (up to 1 year)
Secondary	External tooth stains	Lobene index based on the intensity and area of stains covered on the labial surfaces of the anterior teeth was used. Buccal surfaces of teeth are divided into two gingival crescent and body. In this index intensity and area measured on gingival crescent and body separately and also in combination by multiplying intensity and area. An index for the entire mouth is determined by dividing the total score by the number surfaces examined	November 2010 - October 2011 (up to 1 year)