Comparison Between Two Coronally Positioned Flap With Connective Tissue

March 23, 2013 updated by: Sergio Iván Losada Amaya, Universidad El Bosque, Bogotá

Comparison of Two Bilaminar Techniques for Root Covering of Miller´s Recessions Class I and II: A Blind, Randomized Controlled Clinical Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a blind, randomized controlled clinical trial.

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Bogotá, D. C., Colombia, 110121
        • Universidad El Bosque

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: coronally mucosal thickness flap
coronally mucosal thickness flap plus connective tissue graft for root coverage (subepithelial connective tissue graft)
Procedure: coronally mucosal thickness flap
The design of the flap will be performed according to the technique described by Greenwell H, Vance G, Munninger B and Johnston H.
Other Names:
  • superficial-layer split-tihickness flap
Active Comparator: coronally partial thickness flap
coronally partial thickness flap plus connective tissue for root coverage (subepithelial connective tissue graft)
Procedure: coronally partial thickness flap plus connective tissue
The design of the flap will be performed according to the technique described by de Sanctis and Zucchelli 2007.
Other Names:
  • subepithelial connective tissue graft
  • coronally positioned flap

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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"
Time Frame: one month (plus or minus 2 days), three months (plus or minus 3 days) and six months (plus or minus 5 days)
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

Outcome Measure
Time Frame
Assess the proportion of root coverage
Time Frame: one month (plus or minus 2 days), Three months (plus or minus 3 days) and six month (plus or minus 5 days)
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
Time Frame: one month (plus or minus 2 days), three months (plus or minus 3 days) and six months (plus or minus 5 days)
one month (plus or minus 2 days), three months (plus or minus 3 days) and six months (plus or minus 5 days)

Other Outcome Measures

Outcome Measure
Time Frame
Assess the frequency of adverse events
Time Frame: 0 hours (intrasurgical), 1-24 hours (immediate postoperative), 25 hours to 6 days (mediate postoperative) and 7 or more days (late postoperative)
0 hours (intrasurgical), 1-24 hours (immediate postoperative), 25 hours to 6 days (mediate postoperative) and 7 or more days (late postoperative)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad El Bosque, Bogotá

Investigators

  • Principal Investigator: Sergio I Losada Amaya, Professor, Universidad El Bosque- UNIECLO
  • Study Chair: Jaime A Marquez Cristo, Professor, Universidad El Bosque- UNIECLO
  • Study Chair: Miguel F Vargas del Campo, Professor, Universidad El Bosque- UNIECLO
  • Study Chair: Silie S Arboleda Salaiman, Professor, Universidad El Bosque- UNIECLO
  • Study Director: Maria I Pardo Silva, Professor, Universidad El Bosque- UNIECLO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Anticipated)

April 1, 2014

Study Completion (Anticipated)

August 1, 2014

Study Registration Dates

First Submitted

March 11, 2013

First Submitted That Met QC Criteria

March 15, 2013

First Posted (Estimate)

March 20, 2013

Study Record Updates

Last Update Posted (Estimate)

March 26, 2013

Last Update Submitted That Met QC Criteria

March 23, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCI-2012-359

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gingival Recession

Clinical Trials on coronally mucosal thickness flap

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe