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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a blind, randomized controlled clinical trial.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad El Bosque, Bogotá

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2014

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PCI-2012-359

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