Free Gingival Graft Versus Connective Tissue Graft

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: Recruiting
• Conditions: Gingival Recession; Gingival Recession, Localized
• Intervention / Treatment: Procedure: Free gingival graft; Procedure: Connective tissue graft

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: France Lambert, PhD; Phone Number: +32 4 270 31 05; Email: france.lambert@chuliege.be
• Study Contact Backup: Name: Isabelle Laleman, PhD

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Digital mean root coverage	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

Outcome Measure	Measure Description	Time Frame
Complete root coverage	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	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	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	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	evaluated at baseline using couloured paperpoints inserted into the sulcus.	Baseline, 3 months, 6 months and up to 10 years after surgery
CAL	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	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	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	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	Biological complications reported by the investigators	Baseline, 3 months, 6 months and up to 10 years after surgery
Digital complete root coverage	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	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	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	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

• Sponsor: Centre Hospitalier Universitaire de Liege
• Investigators: Principal Investigator: Szoted Gilles, MSc, ULiège

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): July 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 28, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Actual): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 28, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Gingival recession; Connective tissue graft; Free gingival graft
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID 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