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

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01598155
Enrollment
70
Registered
2012-05-15
Start date
2012-05-31
Completion date
2016-01-31
Last updated
2014-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis

Keywords

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

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.

Interventions

PROCEDUREGroup 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.

PROCEDUREGroup 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.

Sponsors

Federal University of Rio Grande do Sul
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Mean Attachment Loss (AL)24 monthsAL: defined as the distance from the CEJ to the bottom of the pocket/sulcus.

Secondary

MeasureTime frameDescription
Periodontal Probing Depth (PPD)24 monthsPPD: defined as the distance from the free gingival margin to the bottom of the pocket/sulcus.
Microbiological markers24 monthsTo assess the prevalence of P gingivalis, P micra and D pneumosintis on the subgingival plaque samples

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026