Free Gingival Graft Versus Connective Tissue Graft

September 28, 2022 updated by: Isabelle Laleman, Centre Hospitalier Universitaire de Liege

Efficacy of Free Gingival Graft Versus Connective Tissue Graft in the Treatment of Gingival Recessions at the Lower Incisors: a RCT

This study wil compare FGG and CTG for recession coverage in the anterior mandibula.

Study Overview

Status

Status

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

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.

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.
40

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.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Isabelle Laleman, PhD

Study Locations

  • Belgium
      • Liège, Belgium, 4000
        • Recruiting
        • CHU de Liege
        • Contact:
          • Gilles Szotek, MsC

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

14 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA type I and II subjects
  • Localized Gingival Recessions
  • Recessions Cairo RT I-II-III
  • FMPS < 10%
  • FMBS< 10%
  • <10 cigs/ day
  • No contra-indication against oral surgical interventions
  • Patient is able to give inform consent

Exclusion Criteria:

  • Infection (local or systemic). Each infection will be evaluated prior to study procedure for suitability. Patients with gingivitis or local infection (fracture, apical reaction) will undergo a dental treatment prior to entering the study. In case of systemic infection, the evaluation will be based on medical anamneses, and if necessary will be referred to relevant medical tests.
  • ASA type > II
  • Current pregnancy or breastfeeding women
  • Alcoholism or chronically drug abuse
  • Smokers, ≳ 10 cigarettes per day
  • Immunocompromised patients
  • Uncontrolled diabetes
  • Untreated periodontitis
  • History of previous periodontal surgery (mucogingival or other) on the teeth to be included
  • Presence of severe tooth malposition, rotation or significant version of the tooth to be treated
  • Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of no-compliance or unreliability

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: Quadruple

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.
Active Comparator: Free gingival graft
Free gingival graft will be conducted.
Procedure: Free gingival graft
A free gingival graft will be carried out for recession treatment.
Active Comparator: Connective tissue graft
The recession will be treated with the pouch technique using a connective tissue graft.
Procedure: Connective tissue graft
The pouch technique with a connective tissue graft will be carried out for recession treatment.

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
Measure Description
Time Frame
Digital mean root coverage
Time Frame: Baseline, 3 months, 6 months and up to 10 years after surgery
Defined as the percentage of root coverage in the mid-buccal aspect, taking baseline as a reference. Measured by dividing the mean surface (in mm²) of the root covered by the procedure by the mean surface (in mm²) of root exposed at baseline.
Baseline, 3 months, 6 months and up to 10 years after surgery

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
Measure Description
Time Frame
Complete root coverage
Time Frame: Baseline, 3 months, 6 months and up to 10 years after surgery
Defined as the presence/absence of complete coverage of the recession at the mid-buccal aspect. It will be evaluated by taking the CEJ as a reference line, at the different timepoints.
Baseline, 3 months, 6 months and up to 10 years after surgery
Mean root coverage
Time Frame: Baseline, 3 months, 6 months and up to 10 years after surgery
defined as the percentage of root coverage in the mid-buccal aspect, taking baseline as a reference. The MRC equals to the linear distance (in mm, using a probe) between the mid buccal point of the CEJ and the mid-buccal sulcus at baseline, divided by the distance between the mid buccal point of the CEJ and the mid buccal sulcus. The MRC will be measured as percentage (%)
Baseline, 3 months, 6 months and up to 10 years after surgery
Keratinized tissue height
Time Frame: Baseline, 3 months, 6 months and up to 10 years after surgery
Defined as the linear height of keratinized tissue, measured between the mid-buccal sulcus of the treated tooth and the muco-gingival junction (in mm using a probe). It will be measured at baseline and at the different timepoints.
Baseline, 3 months, 6 months and up to 10 years after surgery
Recession reduction
Time Frame: Baseline, 3 months, 6 months and up to 10 years after surgery
defined as the linear reduction in recession (in mm using a probe), at the mid buccal aspect, between baseline and the different timepoints.
Baseline, 3 months, 6 months and up to 10 years after surgery
Gingival thickness
Time Frame: Baseline, 3 months, 6 months and up to 10 years after surgery
evaluated at baseline using couloured paperpoints inserted into the sulcus.
Baseline, 3 months, 6 months and up to 10 years after surgery
CAL
Time Frame: Baseline, 3 months, 6 months and up to 10 years after surgery
defined as the change in Clinical Attachement of the gingival margin, measured linearly at the mid-buccal aspect, from the JEC to the bottom of the pocket, at the different timepoints.
Baseline, 3 months, 6 months and up to 10 years after surgery
PPD changes
Time Frame: Baseline, 3 months, 6 months and up to 10 years after surgery
defined as the change in depth of the pocket, measured at the mid-buccal aspect using a probe, between baseline and the different timepoints. It will be measured at the different timepoints.
Baseline, 3 months, 6 months and up to 10 years after surgery
Dental hypersensitivity
Time Frame: Baseline, 3 months, 6 months and up to 10 years after surgery
Assessed by 10 s air spray applied to the buccal cervical area (yes/no).
Baseline, 3 months, 6 months and up to 10 years after surgery
Root coverage esthetic score
Time Frame: Baseline, 3 months, 6 months and up to 10 years after surgery
Evaluated at the different timepoints according to Cairo et al. (2009).
Baseline, 3 months, 6 months and up to 10 years after surgery
Biological complications reported by the investigators
Time Frame: Baseline, 3 months, 6 months and up to 10 years after surgery
Biological complications reported by the investigators
Baseline, 3 months, 6 months and up to 10 years after surgery
Digital complete root coverage
Time Frame: Baseline, 3 months, 6 months and up to 10 years after surgery
defined as the presence/absence of complete coverage of the recession at the mid-buccal aspect. It will be evaluated by taking the CEJ as a reference line, at the different timepoints, analyzed digitally
Baseline, 3 months, 6 months and up to 10 years after surgery
Digital recession reduction
Time Frame: Baseline, 3 months, 6 months and up to 10 years after surgery
defined as the reduction in recession (in mm², measured digitally), at the mid buccal aspect, between baseline and the different timepoints. It will be measured at the different timepoints.
Baseline, 3 months, 6 months and up to 10 years after surgery
Digital Keratinized Tissue Height
Time Frame: Baseline, 3 months, 6 months and up to 10 years after surgery
Defined as the changes in keratinized tissue surface (surface delimited mesio-distally by the perpendicular projection of a line passing by the contact-point and apico-coronally by the muco-gingival junction and the gingival margin, at the mid-buccal aspect of the tooth.
Baseline, 3 months, 6 months and up to 10 years after surgery
Digital gingival soft tissue profile
Time Frame: Baseline, 3 months, 6 months and up to 10 years after surgery
Defined as the change in gingival soft tissue thickness between baseline and the different timepoints, measured at the mid buccal aspect, between baseline and the different timepoints.
Baseline, 3 months, 6 months and up to 10 years after surgery

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.
Centre Hospitalier Universitaire de Liege

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: Szoted Gilles, MSc, ULiège

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 (Actual)

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.
September 1, 2021

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.
July 31, 2023

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.
December 31, 2023

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).
September 21, 2022

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.
September 28, 2022

First Posted (Actual)

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.
October 3, 2022

Study Record Updates

Last Update Posted (Actual)

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.
October 3, 2022

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.
September 28, 2022

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.
September 1, 2022

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.
  • 2021-242

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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