Effect of Dose-dependent Platelet Rich Fibrin(PRF)

NCT02882464 | Completed

• 1 other identifier: 10/3
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

Brief Summary

Miller Class I Gingival Recessions (GR) have been treated by using Coronally Advanced Flap (CAF) with Platelet Rich Fibrin membrane (PRF membrane) or Connective Tissue Graft (CTG). The aim of this study was to evaluate the effect of different multiple layers of PRF membranes for the treatment of GR and compare the results with CTG procedure.

Conditions

Gingival Recession

Keywords

gingival recession; mucogingival surgery

Outcome Measures

Primary Outcomes (3)

• Change from baseline clinical measurement of gingival depth and gingival recession by periodontal Williams Type Probe as millimeter at postoperative 6 month

  All clinical measurement were recorded by same periodontal probe(Williams Probe)as height in meters. All measurement were calculated as mean ± standard deviation for per tooth. Clinical measurement following as: 1) Recession Depth: the distance from the CEJ to the most apical point of free gingival margin. 2) Recession Width: horizontal distance of recession in the mesio-distal direction at CEJ 3) Keratinized Tissue Height (KTH): the distance from the mucogingival junction to free gingival margin. 4)Probing Depth 5) Clinical Attachment Level

  before surgery and following surgery sixth month

• Change from baseline measurement of keratinized tissue thickness on defects region by spreader and digital calliper at 6 months

  2\) Keratinized Tissue Thickness (KTT): Keratinized tissue thickness was measured under local anesthesia from a mid-point location between the gingival margin and mucogingival junction with a spreader and its stopper silicon

  before surgery and following surgery sixth month

• Change from baseline measurement root coverage at 6 months in millimeters by periodontal probe and change from baseline measurement of root coverage percentage using calculate formula at 6 months

  Root Coverage: (RC) was calculated in millimeters and percentages according to the following formulas: \[(pre operative RD - post operative RD) / pre operative RD\]×100.

  before surgery and following surgery sixth month

Secondary Outcomes (1)

• Number of participant with treatment related postoperative pain using Visual Analogue Scale on application of PRF and CAF+CTG

  first and seventh day

Study Arms (3)

2PRF+CAF

EXPERIMENTAL

Two tubes of blood samples were centrifuged by PC-02 Centrifuged device. This centrifuged device is used with 2700 rpm and for 12 minutes( PC-02 Centrifuge, Process,France). PRF were prepared for patients in 2 layer platelet rich fibrin membrane with coronally advanced flap group (2PRF+CAF). Following this, in test groups, a horizontal sulcular incision was designed at the buccal side of recession area at the level of CEJ. The incision was extended in the interdental area to be connecting CEJ. The root was planned and hard accumulations were removed but no chemical root treatment was performed. In 2PRF+CAF group: two layers of stacked PRF membranes were positioned over the recession area at the level of CEJ and flpa is positioned coronally.

Device: PC-02 Centrifuge device,2PRF+CAF; Device: PC-02 Centrifuge device, 4 PRF+CAF; Procedure: CTG+CAF

4PRF+CAF

EXPERIMENTAL

Four tubes of blood samples were centrifuged by PC-02 Centrifuged device,four layers of PRF membranes were prepared for patients in 4 layer platelet rich fibrin membrane with coronally advanced flap.(4PRF+CAF). This centrifuged device is used with 2700 rpm and for 12 minutes( PC-02 Centrifuge, Process,France) Following this, in test groups, a horizontal sulcular incision was designed at the buccal side of recession area at the level of CEJ. The incision was extended in the interdental area to be connecting CEJ. The root was planned and hard accumulations were removed but no chemical root treatment was performed. In 4PRF+CAF group: four layers of stacked PRF membranes were positioned over the recession area at the level of CEJ and flap is coronally positioned.

Device: PC-02 Centrifuge device,2PRF+CAF; Device: PC-02 Centrifuge device, 4 PRF+CAF; Procedure: CTG+CAF

CTG+CAF

ACTIVE COMPARATOR

The surgical technique in coronally advanced flap with subepithelial connective tissue graft (CTG+CAF) group was "envelope technique" as described by Raetzke. The papillae were dis epithelialized. The root was planned and hard accumulations were removed but no chemical root treatment was performed. The connective tissue graft was harvested from the palate using "trap-door technique" described by Edel. Epithelial layer was elevated with a horizontal and two vertical incisions. The connective tissue graft was harvested as 1 mm by using a standard caliper, then epithelial layer was sutured by resorbable suture. The connective tissue graft was sutured to the recipient bed by resorbable suture at the level of CEJ.

Device: PC-02 Centrifuge device,2PRF+CAF; Device: PC-02 Centrifuge device, 4 PRF+CAF; Procedure: CTG+CAF

Interventions

PC-02 Centrifuge device,2PRF+CAF DEVICE

In 2PRF+CAF group two layers of stacked PRF membranes were positioned over the recession area at the level of cemento-enamel junction(CEJ). In CAF+2PRF group,two layers of stacked PRF membranes were positioned over the recession area at the level of CEJ

Also known as: 2 layers Platelet rich fibrin+ coronally advanced flap

2PRF+CAF; 4PRF+CAF; CTG+CAF

PC-02 Centrifuge device, 4 PRF+CAF DEVICE

Following this, in test groups, a horizontal sulcular incision was designed at the buccal side of recession area at the level of CEJ. The incision was extended in the interdental area to be connecting CEJ. A split thickness flap was raised without vertical incision.18 The papillae were disepithelialized. The root was planned and hard accumulations were removed but no chemical root treatment was performed. In test group-1, two layers of stacked PRF membranes were positioned over the recession area at the level of CEJ. In test group-2, four layers of stacked PRF membranes were positioned over the recession area at the level of CEJ (Figure 2). Membranes were sutured to the recipient bed by a resorbable suture (polyglycolic acid 6/0, Doğsan, Turkey) at the level of CEJ.

Also known as: 4 layers Platelet Rich Fibrin + coronally advanced flap

2PRF+CAF; 4PRF+CAF; CTG+CAF

CTG+CAF PROCEDURE

The connective tissue graft was sutured to the recipient bed by resorbable suture at the level of CEJ. Split thickness flap was coronally advanced and sutured by resorbable suture. Finally, periodontal dressing was fixed on the recipient surgical area.

Also known as: Connective Tissue Graft + Coronally Advanced Flap

2PRF+CAF; 4PRF+CAF; CTG+CAF

Eligibility Criteria

• Age: 18 Years - 52 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Periodontally and systemically healthy patient, ≥ 18 years.
• Miller Class I gingival recession at the buccal aspect of lower and upper incisors, canines or premolars.
• The presence of ≥ 2 mm keratinized tissue apical to the recession.
• The presence of identifiable cemento enamel junction (CEJ).
• ≤ 2 mm probing depth (PD)

You may not qualify if:

• Smoking
• Pregnancy
• Periodontal surgery in the past six months.
• Caries, deep abrasion, restoration or pulpal pathology on the involved tooth.

Sponsors & Collaborators

• Gazi University: lead

Related Publications (4)

• Eren G, Atilla G. Platelet-rich fibrin in the treatment of localized gingival recessions: a split-mouth randomized clinical trial. Clin Oral Investig. 2014 Nov;18(8):1941-8. doi: 10.1007/s00784-013-1170-5. Epub 2013 Dec 22.

  PMID: 24362634 RESULT

• Keceli HG, Kamak G, Erdemir EO, Evginer MS, Dolgun A. 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. J Periodontol. 2015 Nov;86(11):1221-30. doi: 10.1902/jop.2015.150015. Epub 2015 Jul 16.

  PMID: 26177630 RESULT

• Tunaliota M, Ozdemir H, Arabaciota T, Gurbuzer B, Pikdoken L, Firatli E. Clinical evaluation of autologous platelet-rich fibrin in the treatment of multiple adjacent gingival recession defects: a 12-month study. Int J Periodontics Restorative Dent. 2015 Jan-Feb;35(1):105-14. doi: 10.11607/prd.1826.

  PMID: 25734713 RESULT

• Culhaoglu R, Taner L, Guler B. Evaluation of the effect of dose-dependent platelet-rich fibrin membrane on treatment of gingival recession: a randomized, controlled clinical trial. J Appl Oral Sci. 2018 May 14;26:e20170278. doi: 10.1590/1678-7757-2017-0278.

  PMID: 29768524 DERIVED

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Rana Culhaoglu, PhD Dr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Dt

Study Record Dates

• First Submitted: June 5, 2016
• First Posted: August 29, 2016
• Study Start: April 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: August 29, 2016

Record last verified: 2016-08