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

NCT ID: NCT01598155

Last Updated: 2014-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2016-01-31

Brief Summary

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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

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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.

Conditions

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Periodontitis

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Supragingival biofilm control

Group Type EXPERIMENTAL

Group 1 - Supragingival biofilm control

Intervention Type PROCEDURE

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.

Supra- and subgingival biofilm control

Group Type EXPERIMENTAL

Group 2 - Supra- and subgingival biofilm control

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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G1 G2

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Rio Grande do Sul

OTHER

Sponsor Role lead

Responsible Party

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Sabrina Carvalho Gomes

DDS, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sabrina Carvalho Gomes, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul

Locations

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School of Dentistry, Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

References

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Angst PDM, Van der Velden U, Susin C, Gomes SC. Supportive periodontal care with or without subgingival instrumentation: Microbiological results of a 2-year randomized clinical trial. J Clin Periodontol. 2024 Oct;51(10):1302-1310. doi: 10.1111/jcpe.14038. Epub 2024 Jul 2.

Reference Type DERIVED
PMID: 38956881 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33899268 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31378975 (View on PubMed)

Other Identifiers

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SGomes 01

Identifier Type: -

Identifier Source: org_study_id