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

December 7, 2014 updated by: Sabrina Carvalho Gomes, Federal University of Rio Grande do Sul

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90035-003
        • School of Dentistry, Federal University of Rio Grande do Sul

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supragingival biofilm control
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.
Other Names:
  • G1
Experimental: Supra- and subgingival biofilm control
Procedure: 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.
Other Names:
  • G2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Attachment Loss (AL)
Time Frame: 24 months
AL: defined as the distance from the CEJ to the bottom of the pocket/sulcus.
24 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Rio Grande do Sul

Investigators

  • Principal Investigator: Sabrina Carvalho Gomes, DDS, PhD, Federal University of Rio Grande do Sul

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

May 10, 2012

First Submitted That Met QC Criteria

May 11, 2012

First Posted (Estimate)

May 15, 2012

Study Record Updates

Last Update Posted (Estimate)

December 9, 2014

Last Update Submitted That Met QC Criteria

December 7, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGomes 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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