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

Not Applicable

• Conditions: Periodontitis
• Interventions: Procedure: Group 1 - Supragingival biofilm control; Procedure: Group 2 - Supra- and subgingival biofilm control

• Registration Number: NCT01598155
• Lead Sponsor: Federal University of Rio Grande do Sul

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-10
• Study First Submitted QC: 2012-05-11
• Study First Posted: 2012-05-15
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-07
• Last Update Posted: 2014-12-09
• Primary Completion: 2016-01
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supragingival biofilm control	Group 1 - Supragingival biofilm control	-
Supra- and subgingival biofilm control	Group 2 - Supra- and subgingival biofilm control	-

Primary Outcome Measures

Name	Time	Method
Mean Attachment Loss (AL)	24 months	AL: defined as the distance from the CEJ to the bottom of the pocket/sulcus.

Secondary Outcome Measures

Name	Time	Method
Periodontal Probing Depth (PPD)	24 months	PPD: defined as the distance from the free gingival margin to the bottom of the pocket/sulcus.
Microbiological markers	24 months	To assess the prevalence of P gingivalis, P micra and D pneumosintis on the subgingival plaque samples

Trial Locations

Locations (1)

School of Dentistry, Federal University of Rio Grande do Sul; 🇧🇷 Porto Alegre, RS, Brazil