Free Gingival Graft Versus Connective Tissue Graft
Primary Purpose
Gingival Recession, Gingival Recession, Localized
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Free gingival graft
Connective tissue graft
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession focused on measuring Gingival recession, Free gingival graft, Connective tissue graft
Eligibility Criteria
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
Sites / Locations
- CHU de LiègeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Free gingival graft
Connective tissue graft
Arm Description
Free gingival graft will be conducted.
The recession will be treated with the pouch technique using a connective tissue graft.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05563428
First Posted
September 21, 2022
Last Updated
September 28, 2022
Sponsor
Centre Hospitalier Universitaire de Liege
1. Study Identification
Unique Protocol Identification Number
NCT05563428
Brief Title
Free Gingival Graft Versus Connective Tissue Graft
Official Title
Efficacy of Free Gingival Graft Versus Connective Tissue Graft in the Treatment of Gingival Recessions at the Lower Incisors: a RCT
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire de Liege
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study wil compare FGG and CTG for recession coverage in the anterior mandibula.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession, Gingival Recession, Localized
Keywords
Gingival recession, Free gingival graft, Connective tissue graft
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Free gingival graft
Arm Type
Active Comparator
Arm Description
Free gingival graft will be conducted.
Arm Title
Connective tissue graft
Arm Type
Active Comparator
Arm Description
The recession will be treated with the pouch technique using a connective tissue graft.
Intervention Type
Procedure
Intervention Name(s)
Free gingival graft
Intervention Description
A free gingival graft will be carried out for recession treatment.
Intervention Type
Procedure
Intervention Name(s)
Connective tissue graft
Intervention Description
The pouch technique with a connective tissue graft will be carried out for recession treatment.
Primary Outcome Measure Information:
Title
Digital mean root coverage
Description
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.
Time Frame
Baseline, 3 months, 6 months and up to 10 years after surgery
Other Pre-specified Outcome Measures:
Title
Complete root coverage
Description
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.
Time Frame
Baseline, 3 months, 6 months and up to 10 years after surgery
Title
Mean root coverage
Description
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 (%)
Time Frame
Baseline, 3 months, 6 months and up to 10 years after surgery
Title
Keratinized tissue height
Description
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.
Time Frame
Baseline, 3 months, 6 months and up to 10 years after surgery
Title
Recession reduction
Description
defined as the linear reduction in recession (in mm using a probe), at the mid buccal aspect, between baseline and the different timepoints.
Time Frame
Baseline, 3 months, 6 months and up to 10 years after surgery
Title
Gingival thickness
Description
evaluated at baseline using couloured paperpoints inserted into the sulcus.
Time Frame
Baseline, 3 months, 6 months and up to 10 years after surgery
Title
CAL
Description
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.
Time Frame
Baseline, 3 months, 6 months and up to 10 years after surgery
Title
PPD changes
Description
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.
Time Frame
Baseline, 3 months, 6 months and up to 10 years after surgery
Title
Dental hypersensitivity
Description
Assessed by 10 s air spray applied to the buccal cervical area (yes/no).
Time Frame
Baseline, 3 months, 6 months and up to 10 years after surgery
Title
Root coverage esthetic score
Description
Evaluated at the different timepoints according to Cairo et al. (2009).
Time Frame
Baseline, 3 months, 6 months and up to 10 years after surgery
Title
Biological complications reported by the investigators
Description
Biological complications reported by the investigators
Time Frame
Baseline, 3 months, 6 months and up to 10 years after surgery
Title
Digital complete root coverage
Description
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
Time Frame
Baseline, 3 months, 6 months and up to 10 years after surgery
Title
Digital recession reduction
Description
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.
Time Frame
Baseline, 3 months, 6 months and up to 10 years after surgery
Title
Digital Keratinized Tissue Height
Description
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.
Time Frame
Baseline, 3 months, 6 months and up to 10 years after surgery
Title
Digital gingival soft tissue profile
Description
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.
Time Frame
Baseline, 3 months, 6 months and up to 10 years after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
France Lambert, PhD
Phone
+32 4 270 31 05
Email
france.lambert@chuliege.be
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle Laleman, PhD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Szoted Gilles, MSc
Organizational Affiliation
ULiège
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles Szotek, MsC
12. IPD Sharing Statement
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Free Gingival Graft Versus Connective Tissue Graft
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