Clinical trial NCT06509867: Comparison of De-Epithelialized Gingival Graft With or Without Platelet Rich Fibrin in Multiple Gingival Recessions
Official title: The Clinical and Patient Morbidity Comparison of De-Epithelialized Gingival Graft With or Without Platelet Rich Fibrin in Multiple Gingival Recessions: A Split-mouth, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession, Generalized
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 15 patients were surgically treated with coronally advanced flap (CAF) associated with de-epithelialized gingival graft. Groups were defined as DGG and DGG+PRF:

DGG Group (n=15): de-epithelialized subepithelial connective tissue grafts + coronally advanced flap DGG+PRF Group (n=15): de-epithelialized subepithelial connective tissue grafts+ L-Platelet Rich Fibrin + Coronally advanced flap
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the clinical efficacy and patient reported outcome measures of de-epithelialized gingival graft (DGG) with or without platelet rich fibrin on treatment of multiple adjacent gingival recessions with coronally advanced flap (CAF) technique.

Detailed description: Fifteen patients with split-mouth multiple gingival recessions affecting at least 3 adjacent teeth will be treated with either DGG or DGG+PRF. Recession depth(RD) and width(RW), probing depth(PD), clinical attachment level(CAL), keratinized tissue width (KTW), gingival thickness(GT), and percentage of root coverage (RC%) will be evaluated at 1, 3 and 6 months postoperatively. For patient reported outcome measurements, oral health impact factor-14 (OHIP-14) scores, postoperative pain, bleeding, discomfort and painkiller consumption will be recorded.

A total of 15 patients will surgically treated with coronally advanced flap (CAF) associated with de-epithelialized gingival graft. Groups were defined as DGG and DGG+PRF:

DGG Group (n=15): de-epithelialized subepithelial connective tissue grafts + coronally advanced flap DGG+PRF Group (n=15): de-epithelialized subepithelial connective tissue grafts+ L-Platelet Rich Fibrin + Coronally advanced flap

Eligibility criteria: Inclusion criteria of participants were as belows:

Age \> 18 years Systemically healthy and non-smoker Full-mouth plaque index and full-mouth gingival index score\< 20% No mucogingival surgery experience at operation area No active periodontal disease Patients who have not received orthodontic treatment

Exclusion criteria of participants were as belows:

Pregnancy and lactation Bruxism or occlusal trauma Medical contradictions and for periodontal plastic surgery (i.e. mental disorders) Medication intake

Inclusion criteria of surgical area were as below; Presence of at least three single-rooted teeth (anterior-premolar) with RT1 Class \[25\] buccal gingival recession defects ≥2 mm in depth Keratinized gingival width\<3 mm Sufficient oral hygiene (bleeding on probing \<10%, Periodontal Depth\<3 mm) Patients without restoration and/or filling in the gingival recession area Absence of non-carious cervical lesions and non-detectable cemento-enamel junction (CEJ) at the defect sites

Primary outcomes:
measure: percentage of root coverage
timeFrame: at 6th month
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Faculty of Dentistry
Study officials:
References:
citation: Zucchelli G, Mele M, Stefanini M, Mazzotti C, Marzadori M, Montebugnoli L, de Sanctis M. Patient morbidity and root coverage outcome after subepithelial connective tissue and de-epithelialized grafts: a comparative randomized-controlled clinical trial. J Clin Periodontol. 2010 Aug 1;37(8):728-38. doi: 10.1111/j.1600-051X.2010.01550.x. Epub 2010 Jun 24.
citation: Zucchelli G, Mele M, Mazzotti C, Marzadori M, Montebugnoli L, De Sanctis M. Coronally advanced flap with and without vertical releasing incisions for the treatment of multiple gingival recessions: a comparative controlled randomized clinical trial. J Periodontol. 2009 Jul;80(7):1083-94. doi: 10.1902/jop.2009.090041.
citation: Kuka S, Ipci SD, Cakar G, Yilmaz S. Clinical evaluation of coronally advanced flap with or without platelet-rich fibrin for the treatment of multiple gingival recessions. Clin Oral Investig. 2018 Apr;22(3):1551-1558. doi: 10.1007/s00784-017-2225-9. Epub 2017 Oct 20.