Clinical trial NCT01598155: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontitis
Keywords: dental biofilm
periodontitis
maintenance
randomized clinical trial
biomarkers
bacterias
gingival crevicular fluid
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
First posted: 2012-05-15
Enrollment: 70
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mean Attachment Loss (AL)
timeFrame: 24 months
Secondary outcomes:
measure: Periodontal Probing Depth (PPD)
timeFrame: 24 months
measure: Microbiological markers
timeFrame: 24 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: School of Dentistry, Federal University of Rio Grande do Sul
state: RS
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Sabrina Carvalho Gomes, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.