Clinical trial NCT02397122: Platelet-rich Fibrin and Connective Tissue Graft in Recession Treatment
Official title: The Adjunctive Effect of Platelet Rich Fibrin to Connective Tissue Graft in the Treatment of Buccal Recession Defects. Results of a Randomized Parallel Group Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2015-03-24
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the trial is to evaluate the effectiveness of coronally advanced flap (CAF)+connective tissue graft(CTG)+platelet-rich fibrin(PRF) combination in Miller I and II recession treatment by comparing with CAF+CTG. 40 patients were surgically treated either with CAF+CTG+PRF (test group) or CAF+CTG (control group). Clinical parameters of plaque index (PI), gingival index (GI), vertical recession (VR), probing depth (PD), attachment level (AL), keratinized tissue width (KTW), horizontal recession (HR), MGJ localization (L-MGJ), tissue thickness (TT) were recorded at baseline, 3 months (PS1) and 6 months (PS2) post-surgery. Root coverage (RC), complete RC (CRC), attachment gain (AG), and keratinized tissue change (KTC) were also calculated.

Detailed description: Given the encouraging effects of platelet-rich fibrin (PRF) in healing and regeneration, it has been hypothesized that PRF might develop the outcomes obtained with coronally advanced flap (CAF)+connective tissue graft(CTG). Therefore, it was aimed to evaluate the effectiveness of CAF + CTG + PRF in Miller Class I and II recession defect treatment by comparing the outcomes with CAF + CTG in a preliminary, controlled, randomized clinical trial (RCT) with a 6-month follow-up. The study was conducted with 40 patients randomly grouped in half shares into indicated study groups. After phase I therapy, clinical variables including plaque index (PI), gingival index (GI), vertical recession (VR), probing depth (PD), attachment level (AL), keratinized tissue width (KTW), horizontal recession (HR), MGJ localization (L-MGJ), tissue thickness (TT) were recorded. The surgical sites were prepared by using sulcular and adjacent vertical incisions and CTGs were harvested from the palatal regions. Different from CAF+CTG group, PRF was prepared by obtaining 10 ml venous blood, centrifugation and extraction of the gel containing highly concentrated platelet cells in CAF+CTG+PRF patients. Then the gel was placed over the exposed root surface in the same group. The CAF was primarily closed and postoperative instructions were given. After suture removal at second postoperative week, the patients were followed-up by monthly recall visits. Same periodontal clinical variables were recorded 3 and 6 months after surgery.

Eligibility criteria: Inclusion Criteria:

* Systemically healthy
* Single Miller type I or II recession defect ≥ 3 mm localized to anterior/premolar area
* No alveolar bone loss
* Identifiable cemento-enamel junction
* Probing depth ≤3mm

Exclusion Criteria:

* Smoking
* Pregnancy
* History of periodontal surgery in last two years
* Mobility
* Excessive occlusal contacts
* Caries
* Loss of vitality

Primary outcomes:
measure: Vertical Recession
timeFrame: Baseline, 6 weeks and 6 months
Secondary outcomes:
measure: Horizontal Recession
timeFrame: Baseline, 6 weeks and 6 months
measure: Probing Depth
timeFrame: Baseline, 6 weeks and 6 months
measure: Attachment Level
timeFrame: Baseline, 6 weeks and 6 months
measure: Keratinized Tissue Width
timeFrame: Baseline, 6 weeks and 6 months
measure: Tissue Thickness
timeFrame: Baseline, 6 weeks and 6 months
Other outcomes:
Locations:
Study officials:
References: