Treatment of Periodontitis by Conventional 4 Weekly Sections or Within 24 Hours

Periodontitis Clinical Trial

Official title:

Effectiveness of Two Non-surgical Periodontal Treatment Protocols: Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02215460
• Other study ID #: FMSQSPT
• Secondary ID: CEP521/102010/19
• Status: Completed
• Phase: Phase 4
• First received: August 8, 2014
• Last updated: August 11, 2014
• Start date: April 2012
• Est. completion date: April 2014

Study information

• Verified date: August 2014
• Source: University of Taubate
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Ethics Committee (CONEP)Brazil: Sanitary National Agency (ANVISA)
• Study type: Interventional

Clinical Trial Summary

Periodontitis is a form of gum disease that affects many people in the world. Its traditional protocol of treatment includes oral hygiene instruction and dental scaling to remove debris, dental plaque and tartar in 4 weekly sections. There is an additional time-reduced option also usually cheaper. In this last one, all above described procedures are performed within 24 hours. However, up to now comparative effectiveness between these both types of treatment is not well understood. For, example it is not clear if patients treated in the shorter-time experienced more pain. Therefore, the present study used several parameters to clarify whether beneficial differences between these therapeutic protocols exist or not. In addition, aspects that could help clinicians' and patient's decisions such as experience of pain and anxiety related to dental treatment were also investigated. After receiving verbal and written explanations and signed the informed consent form 150 individuals (n=15/group) having the most common type of periodontitis in adults were randomly allocated to be treated in 4 weekly sections or within 24 hours. Oral hygiene instructions and dental debridement were performed alone or in conjunction with antimicrobial agents: a mouth rinse containing chlorhexidine or systemic azithromycin antibiotic tablets. The parameters measured at baseline, 3, 6 and 9 months after treatment were: indicators of inflammation, amount of oral debris and malodor; quantification of bacteria in plaque samples collected with paper points from teeth and tongue; amount of produced saliva and self-reported questionnaires to collect information about oral condition, daily activities, pain and anxiety related to dental treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• mild to moderate chronic periodontitis;

• at least 20 natural teeth;

• good general health

Exclusion Criteria:

• systemic diseases or other conditions that could influence the periodontal status;

• events of high blood pressure or diagnosed hypertension;

• alcohol abuse;

• orthodontic devices;

• extended prosthetic fixed devices, removable partial dentures or overhanging restorations;

• pregnancy or breast-feeding;

• history of sensitivity or suspected allergies following the use of oral hygiene products and/or the test antibiotic;

• the need for antibiotic prophylaxis;

• antibiotics and/or anti-inflammatory drug use in the three months prior to the beginning of the study;

• regular use of chemotherapeutic antiplaque/antigingivitis products;

• any furcation lesions;

• periodontal treatment performed within six months prior to study initiation;

• unwillingness to return for follow-up.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Periodontitis

Intervention

Procedure:
• FMS full-mouth scaling
Participants received oral hygiene instructions and full-mouth scaling within 24 hours. Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.
• QS quadrant scaling
Participants received oral hygiene instructions and quadrant scaling in 4 weekly sections. Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.

Drug:
• FMS chlorhexidine rinse
Participants received oral hygiene instructions and full-mouth scaling within 24 hours followed by a 60-day use of 0.12% chlorhexidine mouth rinse (15mL/30 seconds/ 2 times a day). Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.
• FMS placebo rinse
Participants received oral hygiene instructions and full-mouth scaling within 24 hours followed by a 60-day use of placebo mouth rinse (15mL/30 seconds/ 2 times a day). Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.
• FMS azithromycin tablets
Participants received oral hygiene instructions and full-mouth scaling within 24 hours followed by a 3-day use of azithromycin tablets (1 tablet/day). Debridement procedures were carried out Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.
• FMS placebo tablets
Participants received oral hygiene instructions and full-mouth scaling within 24 hours followed by a 3-day use of placebo tablets (1 tablet/day). Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.
• QS azithromycin tablets
Participants received oral hygiene instructions and full-mouth scaling in 4 weekly sections followed by a 3-day use of azithromycin tablets (1 tablet/day). Debridement procedures were carried out Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.
• QS placebo tablets
Participants received oral hygiene instructions and full-mouth scaling in 4 weekly sections followed by a 3-day use of placebo tablets (1 tablet/day). Debridement procedures were carried out Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.
• QS chlorhexidine rinse
Participants received oral hygiene instructions and full-mouth scaling in 4 weekly sections followed by a 60-day use of 0.12% chlorhexidine mouth rinse (15mL/30 seconds/2 times a day). Debridement procedures were carried out Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.
• QS placebo rinse
Participants received oral hygiene instructions and full-mouth scaling in 4 weekly sections followed by a 60-day use of 0.12% placebo mouth rinse (15mL/30 seconds/2 times a day). Debridement procedures were carried out Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.

Locations

Country	Name	City	State
Brazil	Nucleus of periodontal research of University of Taubate	Taubate	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Taubate	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Cortelli JR, CASTRO MVM; BALEJO RDP, ALENCAR CO, GARGIONI AC, CORTELLI SC, COSTA FO. Clinical and microbiological evaluation of one-stage full-mouth disinfection: a short-term study. Revista de Odontologia da UNESP (Online), v. 42, p. 298-303, 2013. DOI:

CORTELLI JR, COSTA FO, ALENCAR CO, CASTRO MVM, GARGIONI AC, AQUINO DR, CORTELLI SC. CLINICAL EFFECTS OF FULL MOUTH OR QUADRANT DEBRIDEMENT WITH CHLOREXIDINA OR AZITROMYCIN. In: IADR-ASIA PACIFIC REGION, 2013, BANGKOK. IADR-APR, 2013. v. 1. p. 158-158.

CORTELLI JR. et al. Clinical/Microbiological Comparative Effects between Full-mouth and Quadrant Debridement plus Chlorhexidine. In: IADR, 2013, SEATTLE. IADR, 2013.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Impact of periodontal treatment on quality of life	The expected positive effect of periodontal treatment on quality of life (score) was measured by comparing baseline data and data collected at 6 and 9 months after therapy	6 and 9 months	No
Other	Impact of periodontal disease on quality of life	The expected negative effect of periodontal disease on quality of life (score) was measured by analyzing baseline data.	Baseline	No
Other	Dental Anxiety experience	Dental Anxiety (score) was measured immediately before treatment.	Baseline	No
Other	Experience of pain	Experience of pain (scale) due to type of scaling was evaluated immediately after treatment.	at the second day for full-mouth scaling groups; or at month for quadrant scaling groups.	No
Other	Changes in nitrite levels	Changes in nitrite levels (mean values) in saliva was determined by comparing baseline and 6 months values.	6 months	No
Other	Improvements in organoleptic and volatile sulphur compounds measurements	The expected positive impact of periodontal treatment on organoleptic (score) and volatile sulphur compounds (mean values) measurements were evaluated at 3 months.	3 months	No
Primary	Improvements in pocket depth and clinical attachment level measurements	Primary outcomes of effectiveness were improvements of the following clinical parameters: periodontal pocket depth (mm) and clinical attachment level (mm) from baseline to 6 months.	Changes in pocket depth and clinical attachment level measurements from baseline to 6 months	No
Secondary	Improvements in plaque index and gingival index	Improvements in plaque index (scores) and gingival index (scores) when baseline data was compared to 3 months data.	Changes from baseline to 3 months	No
Secondary	Maintenance of pocket depth and clinical attachment level measurements	Pocket depth (mm) and clinical attachment level (mm) values observed at 6 were compared to those observed at 9 months.	Changes in pocket depth and clinical attachment level from 6 months to 9 months	No
Secondary	Changes in total bacterial load and levels of selected pathogens	Reductions in total bacterial load and levels of selected pathogens were determined by real time PCR (polymerase chain reaction) in samples from periodontal pockets and dorsal tongue. Values between baseline and 3 months were compared.	3 months	No
Secondary	Changes in volume of gingival crevicular fluid and levels of pro-inflammatory cytokines	Possible reductions in gingival crevicular fluid volume and in concentrations of tumor necrosis factor alfa (TNFa) and interleukin 1 beta (IL-1ß) were measured by comparing values between baseline and 3 months.	3 months	No