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

Primary Purpose

Periodontitis

Status

Unknown status

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Group 1 - Supragingival biofilm control

Group 2 - Supra- and subgingival biofilm control

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring dental biofilm, periodontitis, maintenance, randomized clinical trial, biomarkers, bacterias, gingival crevicular fluid

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

School of Dentistry, Federal University of Rio Grande do Sul

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Supragingival biofilm control

Supra- and subgingival biofilm control

Arm Description

Outcomes

Primary Outcome Measures

Mean Attachment Loss (AL)

AL: defined as the distance from the CEJ to the bottom of the pocket/sulcus.

Secondary Outcome Measures

Periodontal Probing Depth (PPD)

PPD: defined as the distance from the free gingival margin to the bottom of the pocket/sulcus.

Microbiological markers

To assess the prevalence of P gingivalis, P micra and D pneumosintis on the subgingival plaque samples

Full Information

NCT ID

NCT01598155

First Posted

May 10, 2012

Last Updated

December 7, 2014

Sponsor

Federal University of Rio Grande do Sul

1. Study Identification

Unique Protocol Identification Number

NCT01598155

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Unknown status

Study Start Date

May 2012 (undefined)

Primary Completion Date

January 2016 (Anticipated)

Study Completion Date

January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federal University of Rio Grande do Sul

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontitis

Keywords

dental biofilm, periodontitis, maintenance, randomized clinical trial, biomarkers, bacterias, gingival crevicular fluid

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Supragingival biofilm control

Arm Type

Experimental

Arm Title

Supra- and subgingival biofilm control

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Group 1 - Supragingival biofilm control

Other Intervention Name(s)

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Group 2 - Supra- and subgingival biofilm control

Other Intervention Name(s)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Mean Attachment Loss (AL)

Description

AL: defined as the distance from the CEJ to the bottom of the pocket/sulcus.

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Periodontal Probing Depth (PPD)

Description

PPD: defined as the distance from the free gingival margin to the bottom of the pocket/sulcus.

Time Frame

24 months

Title

Microbiological markers

Description

To assess the prevalence of P gingivalis, P micra and D pneumosintis on the subgingival plaque samples

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sabrina Carvalho Gomes, DDS, PhD

Organizational Affiliation

Federal University of Rio Grande do Sul

Official's Role

Principal Investigator

Facility Information:

Facility Name

School of Dentistry, Federal University of Rio Grande do Sul

City

Porto Alegre

State/Province

ZIP/Postal Code

90035-003

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

33899268

Citation

Mendez M, Angst PDM, Oppermann RV, van der Velden U, Gomes SC. Oral health-related quality of life during supportive periodontal therapy: results from a randomized clinical trial. J Clin Periodontol. 2021 Aug;48(8):1103-1110. doi: 10.1111/jcpe.13473. Epub 2021 Jun 17.

Results Reference

derived

PubMed Identifier

31378975

Citation

Angst PDM, Finger Stadler A, Mendez M, Oppermann RV, van der Velden U, Gomes SC. Supportive periodontal therapy in moderate-to-severe periodontitis patients: A two-year randomized clinical trial. J Clin Periodontol. 2019 Nov;46(11):1083-1093. doi: 10.1111/jcpe.13178. Epub 2019 Sep 2.

Results Reference

derived

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

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