Comparison Between Two Coronally Positioned Flap With Connective Tissue

NCT ID: NCT01814592

Last Updated: 2013-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-08-31

Brief Summary

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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

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This is a blind, randomized controlled clinical trial.

Conditions

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Gingival Recession Periodontal Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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coronally mucosal thickness flap

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

Group Type EXPERIMENTAL

coronally mucosal thickness flap

Intervention Type PROCEDURE

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

coronally partial thickness flap

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

Group Type ACTIVE_COMPARATOR

coronally partial thickness flap plus connective tissue

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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subepithelial connective tissue graft coronally positioned flap superficial-layer split-tihickness flap

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad El Bosque, Bogotá

OTHER

Sponsor Role lead

Responsible Party

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Sergio Iván Losada Amaya

Professor, DDS, specialist in periodontics and oral medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sergio I Losada Amaya, Professor

Role: PRINCIPAL_INVESTIGATOR

Universidad El bosque- UNIECLO

Jaime A Marquez Cristo, Professor

Role: STUDY_CHAIR

Universidad El Bosque- UNIECLO

Miguel F Vargas del Campo, Professor

Role: STUDY_CHAIR

Universidad El Bosque- UNIECLO

Silie S Arboleda Salaiman, Professor

Role: STUDY_CHAIR

Universidad El Bosque- UNIECLO

Maria I Pardo Silva, Professor

Role: STUDY_DIRECTOR

Universidad El Bosque- UNIECLO

Locations

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Universidad El Bosque

Bogotá, D. C., Bogotá, D. C., Colombia

Site Status

Countries

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Colombia

Other Identifiers

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PCI-2012-359

Identifier Type: -

Identifier Source: org_study_id

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