Gingival RecessionNCT02397122
Platelet-rich Fibrin and Connective Tissue Graft in Recession Treatment
A study testing platelet-rich fibrin, connective tissue graft and coronally advanced flap in people with Gingival Recession, run by Kırıkkale University.
Trial summary
The aim of the trial is to evaluate the effectiveness of coronally advanced flap (CAF)+connective tissue graft(CTG)+platelet-rich fibrin(PRF) combination in Miller I and II recession treatment by comparing with CAF+CTG. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- platelet-rich fibrin, connective tissue graft and coronally advanced flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Systemically healthy
- Single Miller type I or II recession defect ≥ 3 mm localized to anterior/premolar area
- No alveolar bone loss
- Identifiable cemento-enamel junction
- Probing depth ≤3mm
Who cannot join
- Smoking
- Pregnancy
- History of periodontal surgery in last two years
- Mobility
- Excessive occlusal contacts
- Caries
- Loss of vitality
About this study
Official title: 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
The aim of the trial is to evaluate the effectiveness of coronally advanced flap (CAF)+connective tissue graft(CTG)+platelet-rich fibrin(PRF) combination in Miller I and II recession treatment by comparing with CAF+CTG. 40 patients were surgically treated either with CAF+CTG+PRF (test group) or CAF+CTG (control group). Clinical parameters of plaque index (PI), gingival index (GI), vertical recession (VR), probing depth (PD), attachment level (AL), keratinized tissue width (KTW), horizontal recession (HR), MGJ localization (L-MGJ), tissue thickness (TT) were recorded at baseline, 3 months (PS1) and 6 months (PS2) post-surgery. Root coverage (RC), complete RC (CRC), attachment gain (AG), and keratinized tissue change (KTC) were also calculated.
Read the detailed description
Given the encouraging effects of platelet-rich fibrin (PRF) in healing and regeneration, it has been hypothesized that PRF might develop the outcomes obtained with coronally advanced flap (CAF)+connective tissue graft(CTG). Therefore, it was aimed to evaluate the effectiveness of CAF + CTG + PRF in Miller Class I and II recession defect treatment by comparing the outcomes with CAF + CTG in a preliminary, controlled, randomized clinical trial (RCT) with a 6-month follow-up. The study was conducted with 40 patients randomly grouped in half shares into indicated study groups. After phase I therapy, clinical variables including plaque index (PI), gingival index (GI), vertical recession (VR), probing depth (PD), attachment level (AL), keratinized tissue width (KTW), horizontal recession (HR), MGJ localization (L-MGJ), tissue thickness (TT) were recorded. The surgical sites were prepared by using sulcular and adjacent vertical incisions and CTGs were harvested from the palatal regions. Different from CAF+CTG group, PRF was prepared by obtaining 10 ml venous blood, centrifugation and extraction of the gel containing highly concentrated platelet cells in CAF+CTG+PRF patients. Then the gel was placed over the exposed root surface in the same group. The CAF was primarily closed and postoperative instructions were given. After suture removal at second postoperative week, the patients were followed-up by monthly recall visits. Same periodontal clinical variables were recorded 3 and 6 months after surgery.
- Conditions
- Gingival Recession
- Being tested
- platelet-rich fibrin, connective tissue graft, coronally advanced flap
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet-rich fibrinBiological
autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods
connective tissue graftProcedure or surgery
connective tissue graft was harvested from the palatal region of each patient by single incision method
coronally advanced flapProcedure or surgery
buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft (and platelet-rich fibrin gel)
| Study group | Role | What they receive |
|---|---|---|
| PRF+CAF+CTG | Experimental | platelet-rich fibrin + coronally advanced flap + connective tissue graft Receives: Biological: platelet-rich fibrin; Procedure: connective tissue graft; Procedure: coronally advanced flap |
| CAF+CTG | Active comparator | coronally advanced flap + connective tissue graft Receives: Procedure: connective tissue graft; Procedure: coronally advanced flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertical Recession
Measured from cementoenamel junction to margin of the gingiva by periodontal probe
Measured: Baseline, 6 weeks and 6 months
Secondary outcomes (5)
Horizontal Recession
measured horizontally between two borders of the recession at the line tangential to cementoenamel junction by periodontal probe
Measured: Baseline, 6 weeks and 6 months
Probing Depth
measured from margin of the gingiva to gingival sulcus base by periodontal probe
Measured: Baseline, 6 weeks and 6 months
Attachment Level
measured from cementoenamel junction to gingival sulcus base by periodontal probe
Measured: Baseline, 6 weeks and 6 months
Keratinized Tissue Width
measured from margin of the gingiva to mucogingival junction by periodontal probe
Measured: Baseline, 6 weeks and 6 months
Tissue Thickness
under local anesthesia, measured from 1.5 mm below the margin of the gingiva with a spreader and its stopper silicon disc. Then, distance of the marked point was measured by using a standardized caliper to the closest 0.1 mm by periodontal probe
Measured: Baseline, 6 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startFeb 2013
- Primary completionDec 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, H. Gencay Keceli, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397122
- Sponsor's protocol ID
- KirikkaleU
- Status last verified
- Sep 2018
- First submitted
- 13 Feb 2015
- Last updated
- 26 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02397122
- Acronym / sponsor ID
- KirikkaleU
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 24 Mar 2015 (estimated)
- Results
- Posted 1 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the trial is to evaluate the effectiveness of coronally advanced flap (CAF)+connective tissue graft(CTG)+platelet-rich fibrin(PRF) combination in Miller I and II recession treatment by comparing with CAF+CTG. 40 patients were surgically treated either with CAF+CTG+PRF (test group) or CAF+CTG (control group). Clinical parameters of plaque index (PI), gingival index (GI), vertical recession (VR), probing depth (PD), attachment level (AL), keratinized tissue width (KTW), horizontal recession (HR), MGJ localization (L-MGJ), tissue thickness (TT) were recorded at baseline, 3 months (PS1) and 6 months (PS2) post-surgery. Root coverage (RC), complete RC (CRC), attachment gain (AG), and keratinized tissue change (KTC) were also calculated.
Detailed description
Given the encouraging effects of platelet-rich fibrin (PRF) in healing and regeneration, it has been hypothesized that PRF might develop the outcomes obtained with coronally advanced flap (CAF)+connective tissue graft(CTG). Therefore, it was aimed to evaluate the effectiveness of CAF + CTG + PRF in Miller Class I and II recession defect treatment by comparing the outcomes with CAF + CTG in a preliminary, controlled, randomized clinical trial (RCT) with a 6-month follow-up. The study was conducted with 40 patients randomly grouped in half shares into indicated study groups. After phase I therapy, clinical variables including plaque index (PI), gingival index (GI), vertical recession (VR), probing depth (PD), attachment level (AL), keratinized tissue width (KTW), horizontal recession (HR), MGJ localization (L-MGJ), tissue thickness (TT) were recorded. The surgical sites were prepared by using sulcular and adjacent vertical incisions and CTGs were harvested from the palatal regions. Different from CAF+CTG group, PRF was prepared by obtaining 10 ml venous blood, centrifugation and extraction of the gel containing highly concentrated platelet cells in CAF+CTG+PRF patients. Then the gel was placed over the exposed root surface in the same group. The CAF was primarily closed and postoperative instructions were given. After suture removal at second postoperative week, the patients were followed-up by monthly recall visits. Same periodontal clinical variables were recorded 3 and 6 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRF+CAF+CTG | Experimental | Biological: platelet-rich fibrin, Procedure: connective tissue graft, Procedure: coronally advanced flapplatelet-rich fibrin + coronally advanced flap + connective tissue graft |
| CAF+CTG | Active comparator | Procedure: connective tissue graft, Procedure: coronally advanced flapcoronally advanced flap + connective tissue graft |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Systemically healthy
- Single Miller type I or II recession defect ≥ 3 mm localized to anterior/premolar area
- No alveolar bone loss
- Identifiable cemento-enamel junction
- Probing depth ≤3mm
Key exclusion criteria (7 listed)
- Smoking
- Pregnancy
- History of periodontal surgery in last two years
- Mobility
- Excessive occlusal contacts
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 |
|---|---|---|
| platelet-rich fibrinautologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods | Biological | PRF+CAF+CTG |
| connective tissue graftconnective tissue graft was harvested from the palatal region of each patient by single incision method | Procedure or surgery | CAF+CTG, PRF+CAF+CTG |
| coronally advanced flapbuccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft (and platelet-rich fibrin gel) | Procedure or surgery | CAF+CTG, PRF+CAF+CTG |
Primary outcome
Vertical Recession
Time frame: Baseline, 6 weeks and 6 months
Measured from cementoenamel junction to margin of the gingiva by periodontal probe
5 secondary outcomes
Horizontal Recession
Time frame: Baseline, 6 weeks and 6 months
Probing Depth
Time frame: Baseline, 6 weeks and 6 months
Attachment Level
Time frame: Baseline, 6 weeks and 6 months
Keratinized Tissue Width
Time frame: Baseline, 6 weeks and 6 months
Tissue Thickness
Time frame: Baseline, 6 weeks and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing platelet-rich fibrin, connective tissue graft and coronally advanced flap in people with Gingival Recession, run by Kırıkkale 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 7 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 26 Oct 2018. 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?
Yes. Results are posted in the registry (first posted 1 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Vertical Recession (time frame: Baseline, 6 weeks and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2018.