Clinical trial NCT02335866: Platelet-Rich Fibrin in the Treatment of Multiple Gingival Recessions
Official title: Platelet Rich Fibrin Against Connective Tissue Graft in Treatment of Gingival Recessions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Gingival Recessions
Keywords: Platelet rich fibrin
Gingival Recession
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2015-01-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objective of this study was to evaluate the clinical effectiveness of platelet-rich fibrin membrane used in combination with a coronally advanced flap and to compare it with the use of a subepitelial connective tissue graft in combination with a coronally advanced flap in Miller class I-II bilateral gingival recession treatment

Detailed description: Purpose

The main objective of this study was to evaluate the clinical effectiveness of platelet-rich fibrin (PRF) in combination with modified coronally advanced flap (MCAF) in the treatment of multiple gingival recessions. Furthermore the second aim of the present study was to compare plastic periodontal surgical procedure, with PRF membrane and connective tissue graft, by a randomized splitmouth controlled study.

Clinical effectiveness of platelet-rich fibrin (PRF) in combination with modified coronally advanced flap (MCAF) as measured by Clinical measurements.

Material and Methods

Twenty patients with multiple gingival recession defects (Miller I, II) participated in this split-mouth trial. Sixty defects received either MCAF+PRF (test) or MCAF with subepithelial connective tissue graft (SCTG) (control). Gingival recession depth (RD), gingival recession width (RW), keratinized tissue width (KTW), recession area (RA), probing depth (PD), clinical attachment level (CAL) and gingival thickness (GT) were evaluated at baseline and 6 months. Additionally post-surgery patient satisfaction and pain status were measured by comparing visual analogue scale (VAS) scores.

Clinical measurements were taken at starting point and 6 months postoperatively. The measurements comprised an assessment of probing depth (PD),clinical attachment level (CAL) and gingival recession parameters including recession depth (RD), recession width (RW), keratinized tissue width (KTW) and gingival thickness (GT) were assessed by a calibrated examiner (E. Ö.). PD, CAL, RD, RW and KTW values were recorded by a Williams probe graduated in 1-mm increments and rounded up to the nearest millimeter (Hu Friedy, Chicago, IL, USA). To standardize the clinical measurements acrylic stents were prepared on patients' casts. The following measurements were recorded at the mid-buccal point of the teeth at baseline and6 months after surgery. GT was evaluated using endodontic reamer attached to a rubber stopper inserted perpendicularly into the gingival tissue 3 mm below the gingival margin under local anesthesia, and then the thickness was measured to the nearest 0.1 mm using a caliper.RD was measured from the CEJ to the gingival margin, RW was measured tangentially at the mid-facial CEJ and RA was calculated as the area within the contour of denuded root. KTW recorded as the distance from the mucogingival junction to the gingival margin. Duplicate measurements were made for RD, RW, RA and KTW with an interval of 24 hours and the average value of two measurements was used for the assessment. The postoperative pain was evaluated with a visual analog score (VAS).

Eligibility criteria: Inclusion Criteria:

* non smoking,
* similar bilateral Miller Class I or II20 localized gingival recessions at least ≥3 mm, located on incisors, canines or premolars on both jaws,
* identifiable cemento-enamel junction (CEJ),
* age ≥18 years,
* presence of tooth vitality and absence of restorations and superficial caries in the area to be treated,
* no periodontal surgical treatment on the involved sites,
* sufficient palatal donor tissue at least ≥2.5 mm thickness for the indicated SCTG

Exclusion Criteria:

* Patients in a pregnancy or lactation period or with self-reported history of antibiotic medication within 6 months
* Molar, mobile or fully restorated teeth

Primary outcomes:
measure: Complete root coverage
timeFrame: 6 months
measure: Gingival recession depth
timeFrame: 6 months
Secondary outcomes:
measure: Keratinized tissue width
timeFrame: 6 months
measure: Pain scores
timeFrame: first week after operations
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: NEU Dental School
Study officials:
affiliation: NECMETTİN ERBAKAN UNIVERSITY
name: ELİF ÖNCÜ, PhD
role: STUDY_DIRECTOR
References: