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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sabrina Carvalho Gomes, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT01598155
First received: May 10, 2012
Last updated: November 11, 2013
Last verified: November 2013

May 10, 2012
November 11, 2013
May 2012
December 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01598155 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Periodontitis
  • 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):

    • Scaling, planning and polishing coronary surface;
    • Education and motivation for oral hygiene and daily supragingival biofilm control by the patient.
    Other Name: G1
  • 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.
    Other Name: G2
  • Experimental: Supragingival biofilm control
    Intervention: Procedure: Group 1 - Supragingival biofilm control
  • Experimental: Supra- and subgingival biofilm control
    Intervention: Procedure: Group 2 - Supra- and subgingival biofilm control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
70
December 2014
December 2013   (final data collection date for primary outcome measure)

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.
Both
35 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01598155
SGomes 01
No
Sabrina Carvalho Gomes, Federal University of Rio Grande do Sul
Federal University of Rio Grande do Sul
Not Provided
Principal Investigator: Sabrina Carvalho Gomes, DDS, PhD Federal University of Rio Grande do Sul
Federal University of Rio Grande do Sul
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP