Clinical trial NCT04561947: Treatment of Gingival Recessions with Connective Tissue or Concentrated Growth Factor Membrane Using Tunnel Technique
Official title: Clinical Evaluation of the Treatment of Multiple Gingival Recessions with Connective Tissue Graft or Concentrated Growth Factor Membrane Using Tunnel Technique: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Lead sponsor: Bulent Ecevit University
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled clinical study aimed to evaluate the success of the combination of tunnel technique and concentrated growth factor membrane for root coverage in treating multiple gingival recessions and compare with the gold standard connective tissue graft.

Detailed description: The study included 108 defects in 40 patients with Miller Class I and II gingival recession. Gingival recession defects were randomly divided into two groups. Tunnel technique + connective tissue graft was applied to 20 patients in the control group (51 defects) and tunnel technique + concentrated growth factor membrane was applied to 20 patients in the test group (57 defects). The results at baseline and 6 months were evaluated for the following clinical parameters: Mean root coverage, complete root coverage, probing depth, clinical attachment level, gingival recession depth, gingival recession width, keratinized tissue width and gingival thickness.

Eligibility criteria: Inclusion Criteria:

* age ≥18 years
* periodontally and systemically healthy
* presence of Miller I or II class gingival recession defect in at least two teeth on the buccal aspect of incisors, canine and premolar teeth (≥ 2 mm in depth)
* gingival thickness ≥ 0.8 mm 2 mm apical to the gingival margin
* presence of identifiable cementoenamel junction (CEJ) (step ≤1 mm at the CEJ level and/or presence of a root irregularity/abrasion with identifiable CEJ was accepted
* full-mouth plaque score (FMPS) ≤20%.

Exclusion Criteria:

* smoking
* contraindications for surgical periodontal treatment
* presence of recession defects associated caries, restoration and furcation problems
* use of systemic antibiotics for any reason in the last 3 months.

Primary outcomes:
measure: Complete root coverage
timeFrame: Six months
Secondary outcomes:
measure: Mean root coverage
timeFrame: Six months
measure: Probing depth
timeFrame: Six months
measure: Clinical attachment level
timeFrame: Six months
measure: Gingival recession depth
timeFrame: Six months
measure: Gingival recession width
timeFrame: Six months
measure: Keratinized tissue width
timeFrame: Six months
measure: Gingival thickness
timeFrame: Six months
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Bulent Ecevit U.
Study officials:
affiliation: birsenkorkmaz91@gmail.com
name: Birsen KORKMAZ, assis. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: ZBEU.
name: Umut BALLI, Assoc. Prof.
role: STUDY_DIRECTOR
References:
citation: Korkmaz B, Balli U. Clinical evaluation of the treatment of multiple gingival recessions with connective tissue graft or concentrated growth factor using tunnel technique: a randomized controlled clinical trial. Clin Oral Investig. 2021 Nov;25(11):6347-6356. doi: 10.1007/s00784-021-03935-3. Epub 2021 Apr 8.