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Comparison Between Two Coronally Positioned Flap With Connective Tissue

Primary Purpose

Gingival Recession, Periodontal Atrophy

Status

Unknown status

Phase

Phase 2

Locations

Colombia

Study Type

Interventional

Intervention

coronally partial thickness flap plus connective tissue

coronally mucosal thickness flap

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring coronally positioned flap, connective tissue, gingival margin, gingival recession/ treatment, gingival recession/ surgery, subepithelial connective tissue graft, randomized controlled clinical trial, surgical flaps, Treatment outcome

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Universidad El Bosque

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

coronally mucosal thickness flap

coronally partial thickness flap

Arm Description

coronally mucosal thickness flap plus connective tissue graft for root coverage (subepithelial connective tissue graft)

coronally partial thickness flap plus connective tissue for root coverage (subepithelial connective tissue graft)

Outcomes

Primary Outcome Measures

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"

Secondary Outcome Measures

Assess the proportion of root coverage

Clinical attachment level, width of keratinized tissue and the position of the mucogingival junction following root coverage procedures

Full Information

NCT ID

NCT01814592

First Posted

March 11, 2013

Last Updated

March 23, 2013

Sponsor

Universidad El Bosque, Bogotá

1. Study Identification

Unique Protocol Identification Number

NCT01814592

Brief Title

Comparison Between Two Coronally Positioned Flap With Connective Tissue

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Unknown status

Study Start Date

March 2013 (undefined)

Primary Completion Date

April 2014 (Anticipated)

Study Completion Date

August 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad El Bosque, Bogotá

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gingival Recession, Periodontal Atrophy

Keywords

coronally positioned flap, connective tissue, gingival margin, gingival recession/ treatment, gingival recession/ surgery, subepithelial connective tissue graft, randomized controlled clinical trial, surgical flaps, Treatment outcome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

coronally mucosal thickness flap

Arm Type

Experimental

Arm Description

coronally mucosal thickness flap plus connective tissue graft for root coverage (subepithelial connective tissue graft)

Arm Title

coronally partial thickness flap

Arm Type

Active Comparator

Arm Description

coronally partial thickness flap plus connective tissue for root coverage (subepithelial connective tissue graft)

Intervention Type

Procedure

Intervention Name(s)

coronally partial thickness flap plus connective tissue

Other Intervention Name(s)

subepithelial connective tissue graft, coronally positioned flap

Intervention Description

The design of the flap will be performed according to the technique described by de Sanctis and Zucchelli 2007.

Intervention Type

Procedure

Intervention Name(s)

coronally mucosal thickness flap

Other Intervention Name(s)

superficial-layer split-tihickness flap

Intervention Description

The design of the flap will be performed according to the technique described by Greenwell H, Vance G, Munninger B and Johnston H.

Primary Outcome Measure Information:

Title

Time Frame

one month (plus or minus 2 days), three months (plus or minus 3 days) and six months (plus or minus 5 days)

Secondary Outcome Measure Information:

Title

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)

Title

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)

Other Pre-specified Outcome Measures:

Title

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: