Free Gingival Graft Versus Connective Tissue Graft

Gingival Recession Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05563428
• Other study ID #: 2021-242
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2022
• Source: Centre Hospitalier Universitaire de Liege
• Contact: France Lambert, PhD
• Phone: +32 4 270 31 05
• Email: france.lambert[@]chuliege.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession
• Gingival Recession, Localized

Intervention

Procedure:
• Free gingival graft
A free gingival graft will be carried out for recession treatment.
• Connective tissue graft
The pouch technique with a connective tissue graft will be carried out for recession treatment.

Locations

Country	Name	City	State
Belgium	CHU de Liège	Liège

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	Gingival thickness	evaluated at baseline using couloured paperpoints inserted into the sulcus.	Baseline, 3 months, 6 months and up to 10 years after surgery
Other	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
Other	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
Other	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
Other	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
Other	Biological complications reported by the investigators	Biological complications reported by the investigators	Baseline, 3 months, 6 months and up to 10 years after surgery
Other	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
Other	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
Other	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
Other	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
Primary	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