Clinical trial NCT02018120: Platelet Rich Fibrin in the Treatment of Multiple Gingival Recessions
Official title: Comparison of Platelet Rich Fibrin and Connective Tissue Graft in Treatment of Multiple Gingival Recessions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Keywords: multiple gingival recession
platelet rich fibrin
connective tissue graft
microsurgery
periodontal diseases
gingival recession
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2013-12-23
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized controlled clinical study is to evaluate and compare the effectiveness of platelet rich fibrin (PRF) and connective tissue grafts in the treatment of multiple gingival recessions.

Detailed description: The aim of this randomized controlled clinical study is to evaluate and compare the effectiveness of platelet rich fibrin (PRF) and connective tissue grafts in the treatment of multiple gingival recessions.

Primary outcome variables were percentage of complete root coverage and mean root coverage percentages at 6 months follow up. The secondary outcome variables include keratinized tissue and gingival thickness gain.

Sample size has been estimated as 13 in each treatment arm. All recessions are treated with modified coronally advanced flap. On test sites PRF membrane and on control sites connective tissue grafts will be placed under modified coronally advanced flaps. Random allocation of the treatment sites to test and control groups were performed using a computer software designed for randomization.

Clinical parameters such as gingival index, plaque index, keratinized tissue width, gingival recession depth and width were measured at 1, 3 and 6 months. Probing pocket depth, clinical attachment level, gingival thickness and gingival recession area were measure at baseline and 6 months. All gingival recession-related parameters such as recession height, recession width and recession area and keratinized tissue width along with mean root coverage and complete root coverage were assessed on standardized clinical photographs using an image analysis software.

Clinical photographs were obtained at baseline and 1, 3 and 6 months after surgical intervention. 4 mm length wire was placed on gingiva to check reproducibility and to obtain standardized pictures.

Gingival tissue thickness were measured with an #15 endodontic reamer attached to rubber stopper inserted perpendicularly into the gingival tissue 2 mm below the gingival margin; thickness of the reamer will be measured with a digital caliper.

Mean root coverage percentage was calculated as percentage of covered root surface area at 6 months.

Follow up of subjects was 6 months.

Eligibility criteria: Inclusion Criteria:

* Two or more adjacent teeth with at least 2 mm Miller Class I gingival recessions at non-molar teeth
* Identifiable CEJ on all teeth
* Age ≥ 18
* Presence of tooth vitality and absence of restorations and superficial caries in the treatment area
* No past surgical treatment history of affected area.
* Gingival thickness ≥ 0,8 mm for recession areas.
* Sufficient palatal donor tissue for connective tissue harvesting.

Exclusion Criteria:

* Smoking
* Pregnancy or lactation
* Systematic diseases that may affect outcomes of periodontal therapy
* Self-reported antibiotic medication within three months
* Occlusal trauma in treatment site

Primary outcomes:
measure: Mean root coverage percentage
timeFrame: 6 months
measure: complete root coverage percentage
timeFrame: 6 months
Secondary outcomes:
measure: keratinized tissue width
timeFrame: 6 months
measure: gingival tissue thickness
timeFrame: 6 months
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University School of Dentistry Department of Periodontology
state: Bornova
Study officials:
affiliation: Ege University School of Dentistry
name: Gül Atilla, Professor
role: STUDY_DIRECTOR
References: