Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-02-28 @ 3:47 AM
Study NCT ID:
NCT02018120
Status:
COMPLETED
Last Update Posted:
2013-12-23
First Post:
2013-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Platelet Rich Fibrin in the Treatment of Multiple Gingival Recessions
Sponsor:
Ege University
Organization:
Study Overview
Official Title:
Comparison of Platelet Rich Fibrin and Connective Tissue Graft in Treatment of Multiple Gingival Recessions
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: