Comparison Between Two Coronally Positioned Flap With Connective Tissue

Phase 2

• Conditions: Gingival Recession; Periodontal Atrophy
• Interventions: Procedure: coronally mucosal thickness flap; Procedure: coronally partial thickness flap plus connective tissue

• Registration Number: NCT01814592
• Lead Sponsor: Universidad El Bosque, Bogotá

Brief Summary

The aim of this study is to evaluate the effectiveness of total root coverage between two coronally positioned flap technique in Miller recession Class I and II, in patients attending at "Universidad El Bosque" dental school clinics.

Detailed Description

This is a blind, randomized controlled clinical trial.

Study Timeline

• Status Verified: 2013-03
• Study Start: 2013-03
• Study First Submitted: 2013-03-11
• Study First Submitted QC: 2013-03-15
• Study First Posted: 2013-03-20
• Last Update Submitted: 2013-03-23
• Last Update Posted: 2013-03-26
• Primary Completion: 2014-04
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Class I and II Miller recessions showing a recession depth ≥ 2 mm.
• Recessions isolated and / or maximum continuous two teeth.
• Recessions in incisors, canines and premolars
• Patients 20 to 60 years old.

Exclusion Criteria

• Systemic compromise, that contraindicates any periodontal surgical procedure.

  • Warfarin medication.
  • Uncontrolled diabetes mellitus with glycosylated hemoglobin ≥ 8
  • Chronic steroid therapy (dose of 7.5 mg/ day for more than 14 days)
  • HIV-AIDS infection with CD4 counts <200.
  • Immunosuppression.

• Recessions molars not be taken into account in the study.

• Patients who have used antibiotics one month prior to the surgical procedure.

• Pregnancy.

• Active smoker.

• Patients with a history of periodontal surgery at the recession area that has taken place in the last three months.

• Severe dental malposition, teeth rotation, versions teeth root coverage that contraindicates surgery.

• Non carious cervical lesions or caries where is not visible the cemento- enamel junction (CEJ).

• Active inflammation that contraindicates surgical procedure of the recession.

• Active Orthodontics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
coronally mucosal thickness flap	coronally mucosal thickness flap	coronally mucosal thickness flap plus connective tissue graft for root coverage (subepithelial connective tissue graft)
coronally partial thickness flap	coronally partial thickness flap plus connective tissue	coronally partial thickness flap plus connective tissue for root coverage (subepithelial connective tissue graft)

Primary Outcome Measures

Name	Time	Method
Assess percentage of total root coverage between two subepithelial conective tissue graft technique for covering Class I and II Miller recessions patients attending at dental clinics of "Universidad El Bosque"	one month (plus or minus 2 days), three months (plus or minus 3 days) and six months (plus or minus 5 days)

Secondary Outcome Measures

Name	Time	Method
Assess the proportion of root coverage	one month (plus or minus 2 days), Three months (plus or minus 3 days) and six month (plus or minus 5 days)
Clinical attachment level, width of keratinized tissue and the position of the mucogingival junction following root coverage procedures	one month (plus or minus 2 days), three months (plus or minus 3 days) and six months (plus or minus 5 days)

Trial Locations

Locations (1)

Universidad El Bosque; 🇨🇴 Bogotá, D. C., Colombia