Gingival RecessionPRFNCT02882464
Effect of Dose-dependent Platelet Rich Fibrin(PRF)
A study testing PC-02 Centrifuge device,2PRF+CAF, PC-02 Centrifuge device, 4 PRF+CAF and CTG+CAF in people with Gingival Recession, run by Gazi University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 52 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- PC-02 Centrifuge device,2PRF+CAF, PC-02 Centrifuge device, 4 PRF+CAF and CTG+CAF
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 52 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- Smoking
- Pregnancy
- Periodontal surgery in the past six months.
- Caries, deep abrasion, restoration or pulpal pathology on the involved tooth.
About this study
Official title: Evaluation of Dose-dependent Platelet-rich Fibrin Membrane Effect on Treatment of Gingival Recessions: A Randomized, Controlled, Parallel-designed Clinical Trial
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.
Read the detailed description
The Coronally Advanced Flap (CAF) has been used in combination with various techniques to increase the coverage and obtain the CRC. CAF+connective tissue graft and CAF+platelet concentrated graft are some of these procedures.
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
- Gingival Recession
- Being tested
- PC-02 Centrifuge device,2PRF+CAF, PC-02 Centrifuge device, 4 PRF+CAF, CTG+CAF
- Keywords
- gingival recession, mucogingival surgery
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PC-02 Centrifuge device,2PRF+CAFDevice
Also called 2 layers Platelet rich fibrin+ coronally advanced flap
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+CAFDevice
Also called 4 layers Platelet Rich Fibrin + coronally advanced flap
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+CAFProcedure or surgery
Also called Connective Tissue Graft + Coronally Advanced Flap
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: PC-02 Centrifuge device,2PRF+CAF; Device: PC-02 Centrifuge device, 4 PRF+CAF; Procedure: CTG+CAF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
- 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
Measured: 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.
Measured: 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
Post operative discomfort and bleeding were recorded using a visual analogue scale (VAS). The patients enrolled their pain level for the first 7 days after surgery on a horizontal scale, left endpoint means no pain (0), the middle point means pain (50), right endpoint means severe pain (100). Also, patients enrolled the amount of analgesic they used after surgery
Measured: first and seventh day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study startApr 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Culhaoglu, Gazi University
- Investigators
- Rana Culhaoglu, PhD Dr, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882464
- Sponsor's protocol ID
- 10/3
- Acronym
- PRF
- Status last verified
- Aug 2016
- First submitted
- 5 Jun 2016
- Last updated
- 29 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: There is no plan such as share participant individual data. If necessary, then information can be shared.
Publications
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.
PubMed 24362634Keceli 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.
PubMed 26177630Tunaliota 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.
PubMed 25734713Culhaoglu 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.
PubMed 29768524
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dose-dependent Platelet-rich Fibrin Membrane Effect on Treatment of Gingival Recessions: A Randomized, Controlled, Parallel-designed Clinical Trial
- ClinicalTrials.gov ID
- NCT02882464
- Acronym / sponsor ID
- PRF / 10/3
- Conditions
- Gingival Recession
- Keywords
- gingival recession, mucogingival surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 29 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Coronally Advanced Flap (CAF) has been used in combination with various techniques to increase the coverage and obtain the CRC. CAF+connective tissue graft and CAF+platelet concentrated graft are some of these procedures.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2PRF+CAF | Experimental | Device: PC-02 Centrifuge device,2PRF+CAF, Device: PC-02 Centrifuge device, 4 PRF+CAF, Procedure: CTG+CAFTwo 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. |
| 4PRF+CAF | Experimental | Device: PC-02 Centrifuge device,2PRF+CAF, Device: PC-02 Centrifuge device, 4 PRF+CAF, Procedure: CTG+CAFFour 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. |
| CTG+CAF | Active comparator | Device: PC-02 Centrifuge device,2PRF+CAF, Device: PC-02 Centrifuge device, 4 PRF+CAF, Procedure: CTG+CAFThe 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. |
Who may qualify
- Ages
- 18 to 52 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- Smoking
- Pregnancy
- Periodontal surgery in the past six months.
- Caries, deep abrasion, restoration or pulpal pathology on the involved tooth.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PC-02 Centrifuge device,2PRF+CAFAlso: 2 layers Platelet rich fibrin+ coronally advanced flapIn 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 | Device | 2PRF+CAF, 4PRF+CAF, CTG+CAF |
| PC-02 Centrifuge device, 4 PRF+CAFAlso: 4 layers Platelet Rich Fibrin + coronally advanced flapFollowing 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. | Device | 2PRF+CAF, 4PRF+CAF, CTG+CAF |
| CTG+CAFAlso: Connective Tissue Graft + Coronally Advanced FlapThe 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. | Procedure or surgery | 2PRF+CAF, 4PRF+CAF, CTG+CAF |
Primary outcome
Change from baseline clinical measurement of gingival depth and gingival recession by periodontal Williams Type Probe as millimeter at postoperative 6 month
Time frame: before surgery and following surgery sixth 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
Change from baseline measurement of keratinized tissue thickness on defects region by spreader and digital calliper at 6 months
Time frame: before surgery and following surgery sixth month
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
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
Time frame: before surgery and following surgery sixth month
Root Coverage: (RC) was calculated in millimeters and percentages according to the following formulas: [(pre operative RD - post operative RD) / pre operative RD]×100.
1 secondary outcome
Number of participant with treatment related postoperative pain using Visual Analogue Scale on application of PRF and CAF+CTG
Time frame: first and seventh day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2016.
- Results publication: PubMed 24362634Eren 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.
- Results publication: PubMed 26177630Keceli 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.
- Results publication: PubMed 25734713Tunaliota 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.
- Derived from this study: PubMed 29768524Culhaoglu 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.
- Individual participant dataSharing planned: Undecided. There is no plan such as share participant individual data. If necessary, then information can be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rana Culhaoglu, PhD Dr principal investigator
Questions about this trial
What is this clinical trial studying?
A study testing PC-02 Centrifuge device,2PRF+CAF, PC-02 Centrifuge device, 4 PRF+CAF and CTG+CAF in people with Gingival Recession, run by Gazi University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline clinical measurement of gingival depth and gingival recession by periodontal Williams Type Probe as millimeter at postoperative 6 month (time frame: before surgery and following surgery sixth month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02882464, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2016.