Clinical trial NCT05563428: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Gingival Recession
Gingival Recession, Localized
Keywords: Gingival recession
Free gingival graft
Connective tissue graft
Lead sponsor: Centre Hospitalier Universitaire de Liege
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled trial
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Digital mean root coverage
timeFrame: Baseline, 3 months, 6 months and up to 10 years after surgery
Secondary outcomes:
Other outcomes:
measure: Complete root coverage
timeFrame: Baseline, 3 months, 6 months and up to 10 years after surgery
measure: Mean root coverage
timeFrame: Baseline, 3 months, 6 months and up to 10 years after surgery
measure: Keratinized tissue height
timeFrame: Baseline, 3 months, 6 months and up to 10 years after surgery
measure: Recession reduction
timeFrame: Baseline, 3 months, 6 months and up to 10 years after surgery
measure: Gingival thickness
timeFrame: Baseline, 3 months, 6 months and up to 10 years after surgery
measure: CAL
timeFrame: Baseline, 3 months, 6 months and up to 10 years after surgery
measure: PPD changes
timeFrame: Baseline, 3 months, 6 months and up to 10 years after surgery
measure: Dental hypersensitivity
timeFrame: Baseline, 3 months, 6 months and up to 10 years after surgery
measure: Root coverage esthetic score
timeFrame: Baseline, 3 months, 6 months and up to 10 years after surgery
measure: Biological complications reported by the investigators
timeFrame: Baseline, 3 months, 6 months and up to 10 years after surgery
measure: Digital complete root coverage
timeFrame: Baseline, 3 months, 6 months and up to 10 years after surgery
measure: Digital recession reduction
timeFrame: Baseline, 3 months, 6 months and up to 10 years after surgery
measure: Digital Keratinized Tissue Height
timeFrame: Baseline, 3 months, 6 months and up to 10 years after surgery
measure: Digital gingival soft tissue profile
timeFrame: Baseline, 3 months, 6 months and up to 10 years after surgery
Locations:
city: Liège
country: Belgium
facility: CHU de Liège
Study officials:
affiliation: ULiège
name: Szoted Gilles, MSc
role: PRINCIPAL_INVESTIGATOR
References: