Effect of Supragingival Control Versus Supra- and Subgingival Control in the Periodontal Health During the Maintenance

Periodontitis Clinical Trial

Official title:

The Effect of Supragingival Biofilm Control, and the Combination of Supra and Subgingival Biofilm Control in Periodontal Health of Patients Participating in a Periodontal Preventive Maintenance Program - A Randomized Clinical Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01598155
• Other study ID #: SGomes 01
• Status: Active, not recruiting
• Phase: N/A
• First received: May 10, 2012
• Last updated: December 7, 2014
• Start date: May 2012
• Est. completion date: January 2016

Study information

• Verified date: December 2014
• Source: Federal University of Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

Seventy patients will be previously treated for moderate-to-severe periodontitis according to their individual needs. Thirty days after completion of periodontal treatment, these patients will be randomized to one of the following groups of periodic preventive maintenance (PPM): G1 - performed only control supragingival; G2 - performed supra and subgingival control (when necessary).

The maintenance consultations will be scheduled every 3 months for 24 months. The hypothesis is that the effect of the supragingival control (conducted over 24 months) will be similar to the effect of the supra- and subgingival control combined, above the restoration and progression of periodontitis.

Description:

This randomized clinical trial, single-blind, aims to compare the effect of the supragingival biofilm control with the effect of supra- and subgingival biofilm control, performed by the patient-professional binomial, in periodontal patients treated, above the restoration and progression of periodontitis during the preventive periodic maintenance (PPM). Seventy patients with moderate-to-severe periodontitis, aged from 35 years, will be included. Participants will be periodontally treated according to their needs. After 30 days of the end of treatment, participants will be randomized (stratified for smoking) in two groups: Group 1 (G1)- Supragingival biofilm control; Group 2 (G2)- Supra and subgingival biofilm control. MPP consultation will take place every 3 months, for 24 months, in which the G1 will only receive procedures of supragingival biofilm control, and G2 will receive, beyond the supragingival control, subgingival interventions.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• age from 35 years;

• present at least 12 teeth in the mouth;

• patients diagnosed with moderate-to-severe periodontitis according to the criteria of the AAP (1999):

• to present = 2 interproximal sites with AL = 6 mm AND =1 interproximal site with PD = 5 mm; or

• to present = 2 interproximal sites with AL = 3mm OR = 2 interproximal sites with PD = 5 mm (in different teeth).

Exclusion Criteria:

• presence of systemic conditions unfavorable to periodontal treatment (diabetes, cardiovascular changes with antimicrobial prophylaxis indicated);

• positive history of periodontal treatment and maintenance in the 12 months preceding the study;

• positive history of using anti-inflammatory drugs and antibiotics in the 3 months prior to initial consultation;

• patients in use of fixed orthodontic appliance;

• pregnant patients.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Periodontitis

Intervention

Procedure:
• Group 1 - Supragingival biofilm control
30 days after the end of periodontal treatment, participants assigned to this group, will receive every 3 months (over 24 months): Scaling, planning and polishing coronary surface; Education and motivation for oral hygiene and daily supragingival biofilm control by the patient.
• Group 2 - Supra- and subgingival biofilm control
30 days after the end of periodontal treatment, participants assigned to this group, will receive every 3 months (over 24 months): Scaling, planning and polishing of coronary surface; Education and motivation for oral hygiene and daily supragingival biofilm control by the patient; Subgingival scaling and root planning in sites with persistent bleeding on probing and probing depth unchanged.

Locations

Country	Name	City	State
Brazil	School of Dentistry, Federal University of Rio Grande do Sul	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Attachment Loss (AL)	AL: defined as the distance from the CEJ to the bottom of the pocket/sulcus.	24 months	No
Secondary	Periodontal Probing Depth (PPD)	PPD: defined as the distance from the free gingival margin to the bottom of the pocket/sulcus.	24 months	No
Secondary	Microbiological markers	To assess the prevalence of P gingivalis, P micra and D pneumosintis on the subgingival plaque samples	24 months	No