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

NCT01598155 | Unknown

• 1 other identifier: SGomes 01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Mean Attachment Loss (AL)

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

  24 months

Secondary Outcomes (2)

• Periodontal Probing Depth (PPD)

  24 months

• Microbiological markers

  24 months

Study Arms (2)

Supragingival biofilm control

EXPERIMENTAL

Procedure: Group 1 - Supragingival biofilm control

Supra- and subgingival biofilm control

EXPERIMENTAL

Procedure: Group 2 - Supra- and subgingival biofilm control

Interventions

Group 1 - Supragingival biofilm control 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.

Also known as: G1

Supragingival biofilm control

Group 2 - Supra- and subgingival biofilm control 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.

Also known as: G2

Supra- and subgingival biofilm control

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead

Study Sites (1)

School of Dentistry, Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Related Publications (3)

• 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.

  PMID: 38956881 DERIVED

• 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.

  PMID: 33899268 DERIVED

• 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.

  PMID: 31378975 DERIVED

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Sabrina Carvalho Gomes, DDS, PhD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, PhD

Study Record Dates

• First Submitted: May 10, 2012
• First Posted: May 15, 2012
• Study Start: May 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: December 9, 2014

Record last verified: 2014-12

Locations

BR (1)