Effect of Supragingival Control Versus Supra- and Subgingival Control in the Periodontal Health During the Maintenance
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Periodontitis |
Procedure: Group 1 - Supragingival biofilm control Procedure: Group 2 - Supra- and subgingival biofilm control |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| 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. |
- Mean Attachment Loss (AL) [ Time Frame: 24 months ] [ Designated as safety issue: No ]AL: defined as the distance from the CEJ to the bottom of the pocket/sulcus.
- Periodontal Probing Depth (PPD) [ Time Frame: 24 months ] [ Designated as safety issue: No ]PPD: defined as the distance from the free gingival margin to the bottom of the pocket/sulcus.
- Microbiological markers [ Time Frame: 24 months ] [ Designated as safety issue: No ]To assess the prevalence of P gingivalis, P micra and D pneumosintis on the subgingival plaque samples
| Estimated Enrollment: | 70 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Supragingival biofilm control |
Procedure: 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):
Other Name: G1
|
| Experimental: Supra- and subgingival biofilm control |
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):
Other Name: G2
|
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| Ages Eligible for Study: | 35 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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.
Contacts and Locations| Brazil | |
| School of Dentistry, Federal University of Rio Grande do Sul | Recruiting |
| Porto Alegre, RS, Brazil, 90035-003 | |
| Contact: Patrícia Angst, MSc 55 55 8126 3109 pati_dani@hotmail.com | |
| Contact: Amanda Stadler, MSc 55 51 81682846 amandastadler@hotmail.com | |
| Principal Investigator: | Sabrina Carvalho Gomes, DDS, PhD | Federal University of Rio Grande do Sul |
More Information
No publications provided
| Responsible Party: | Sabrina Carvalho Gomes, DDS, PhD, Federal University of Rio Grande do Sul |
| ClinicalTrials.gov Identifier: | NCT01598155 History of Changes |
| Other Study ID Numbers: | SGomes 01 |
| Study First Received: | May 10, 2012 |
| Last Updated: | May 11, 2012 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Federal University of Rio Grande do Sul:
|
dental biofilm periodontitis maintenance randomized clinical trial |
biomarkers bacterias gingival crevicular fluid |
Additional relevant MeSH terms:
|
Periodontitis Periodontal Diseases Mouth Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on May 21, 2013