Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
21 participants
INTERVENTIONAL
2014-04-30
2015-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Platelet-rich Fibrin and Connective Tissue Graft in Recession Treatment
NCT02397122
Platelet-Rich Fibrin in the Treatment of Multiple Gingival Recessions
NCT02335866
Platelet Rich Fibrin in the Treatment of Multiple Gingival Recessions
NCT02018120
Clinical Evaluation of Injectable Platelet Rich Fibrin With Connective Tissue Graft for the Treatment of Deep Gingival Recession Defects.
NCT04032405
Platelet-Rich Fibrin Prepared With Titanium in the Treatment of Multiple Gingival Recessions
NCT05270941
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Because of a high success rate in the treatment of GR, CAF combined Connective Tissue Graft (CTG) procedure (bilaminar technique) is considered the gold standard for Miller Class I and II recession defects. According to recent studies CAF + CTG is described as a successful technique with a high CRC value and the percent root coverage achieved with this technique ranges from 79.9% to 89.6%. The advantage of this technique is the enhancement of keratinized tissue width which can be explained by the determination of surface epithelium characteristics of CTG. Moreover, there are disadvantages such as patient's discomfort because of postoperative pain or bleeding and second surgical area.
Therefore, the aim of this study was to evaluate the different doses of PRF membranes for the treatment of Miller Class I gingival recessions and compare with CTG procedure that is considered the gold standard.
MATERIALS AND METHODS In this study, sixty-three Miller Class I gingival recessions in twenty two subjects (10 males and 12 females, aged 21 to 52 years) were treated.
Study design This study was a randomized, controlled clinical trial, with a parallel design comparing different amount layers of PRF membranes and CTG for the treatment of Miller Class I gingival recessions. In the test group-1, 21 randomly selected GR were treated with 2 layers PRF membranes(2PRF)+CAF; in the test group-2, 21 randomly selected GR were treated with 4 layers PRF membranes (4PRF) +CAF and in the control group 21 randomly selected GR were treated with CTG+CAF.
Randomization Subjects were defined to one of the three groups with the use of computer-generated randomization scheme. Allocation concealment was obtained with number labeled opaque envelopes that were opened just before the surgery.
Sample size A software program‡ was used to calculate sample size. The power was calculated 85% when there was 20 gingival recession per each group, using the α value as 0.05.
Clinical measurements All clinical measurements were carried out by one of the examiners. Individual acrylic stents were prepared for all patients to take measurements on the constant points. The following clinical measurements were taken 1 week before surgery (baseline) and at the 1, 3 and 6 months follow up visits: 1) Recession Depth(RD) 2) Recession Width(RW) 3) Keratinized Tissue Height (KTH) 4) Plaque Index(PI), 5) Gingival Index(GI), 6) Probing Depth(PD), 7) Keratinized Tissue Thickness(KTT) 8) Clinical Attachment Level(CAL), 9) Root Coverage(RC). Post operative discomfort and bleeding were recorded using a visual analogue scale (VAS).
Surgical Procedure All surgical operations were performed by the same examiner. Patients received local anesthesia at recession sites and donor sites in the control group. Chlorhexidine mouthwash was performed for intraoral disinfection and antiseptic solution for extraoral disinfection.
Before the surgery, intravenous blood samples were collected from the test group patients. Samples were centrifuged and PRF clots were obtained according to the procedure described by Choukroun.14, 17 Two tubes of blood samples were collected and two layers of PRF membranes were prepared for patients in . Four tubes of blood samples were collected and four layers of PRF membranes were prepared for patients in 4PRF+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. A split thickness flap was raised without vertical incision. The papillae were disepithelialized. 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 . In 4PRF+CAF group, four layers of stacked PRF membranes were positioned over the recession area at the level of CEJ. Membranes were sutured to the recipient bed by a 6.0 resorbable suture at the level of CEJ. Split thickness flap was coronally advanced and sutured by a 5.0 resorbable suture.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
2PRF+CAF
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.
PC-02 Centrifuge device,2PRF+CAF
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
PC-02 Centrifuge device, 4 PRF+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. 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.
CTG+CAF
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.
4PRF+CAF
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.
PC-02 Centrifuge device,2PRF+CAF
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
PC-02 Centrifuge device, 4 PRF+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. 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.
CTG+CAF
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.
CTG+CAF
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.
PC-02 Centrifuge device,2PRF+CAF
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
PC-02 Centrifuge device, 4 PRF+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. 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.
CTG+CAF
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PC-02 Centrifuge device,2PRF+CAF
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
PC-02 Centrifuge device, 4 PRF+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. 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.
CTG+CAF
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Miller Class I gingival recession at the buccal aspect of lower and upper incisors, canines or premolars.
3. The presence of ≥ 2 mm keratinized tissue apical to the recession.
4. The presence of identifiable cemento enamel junction (CEJ).
5. ≤ 2 mm probing depth (PD)
Exclusion Criteria
2. Pregnancy
3. Periodontal surgery in the past six months.
4. Caries, deep abrasion, restoration or pulpal pathology on the involved tooth.
18 Years
52 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gazi University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Rana Culhaoglu
Dr Dt
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rana Culhaoglu, PhD Dr
Role: PRINCIPAL_INVESTIGATOR
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
10/3
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.