Root CoverageNCT04942821

The Evaluation Clinical Results of Coronally Advanced Flap With Platelet Rich Fibrin

A study testing Platelet rich fibrin and coronally advanced flap and Connective tissue graft and coronally advanced flap in people with Root Coverage, run by Marmara University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this study was to evaluate the clinical outcomes of platelet- rich fibrin and coronally advanced flap technique in the treatment of multiple gingival recessions in comparison with connective tissue graft technique. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Root Coverage
What is being tested?: Platelet rich fibrin and coronally advanced flap and 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: 12 participants
Where: No sites listed yet
Study dates: 23 Apr 2014to 24 Feb 2017
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Patients had at two quadrants, adjacent Miller Class I and at least 2 mm or deeper recessions
Full mouth plaque score 20% and Full mouth bleeding on probing 10%
no active periodontal disease,
involving incisors, canines and premolars,
age ≥ 18 years

Who cannot join

Patients with general diseases which could affect healing process,
smokers
Patients had undergone periodontal surgery during the pervious 24 months on the involved sites,
pregnant or breastfeeding women
endodontic lesions or non-detectable cemento-enamel junctions at experimental teeth

About this study

Official title: Treatment of Multiple Adjacent Gingival Recessions With Coronally Advanced Flap in Combination With Platelet-Rich Fibrin: A Split-Mouth Study

Read the detailed description

Aim of this study was to evaluate the clinical outcomes of platelet rich fibrin (PRF)+coronally advanced flap (CAF) technique in the treatment of multiple gingival recessions in comparison with connective tissue graft (CTG)+CAF technique.12 patients with bilateral Miller Class I multiple gingival recessions were treated with PRF+CAF (test group) and CTG+CAF (control group) technique in a split-mouth study design. Probing depth, recession depth (RD), clinical attachment level (CAL), recession width, position of gingival margin, papilla width, keratinized tissue height (KTH), keratinized tissue thickness (KTT) were measured at baseline and 3, 6 and 12 months after surgery. Root coverage (RC) and complete root coverage (CRC) ratios were evaluated post-operatively.

Conditions: Root Coverage
Being tested: Platelet rich fibrin and coronally advanced flap, Connective tissue graft and coronally advanced flap
Keywords: Gingival recession, Plastic surgery, 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 fibrin and coronally advanced flapProcedure or surgery
CAF were used in treatment arms. Root planning was performed on the exposed part of roots to provide more biocompatible surface for re-attachment. Two 10 cc tubes with clot activator were used to collect blood from the patient; blood was centrifuged at 2700 rpm for 12 min. PRF box was used to form fibrin clots into membranes. PRF was positioned at the level of the cemento-enamel junction (CEJ), and sutured on the periosteum bed with 6/0 absorbable sutures. Gingival margins on the flap were placed at least 1 mm coronally of the CEJ and sutured with 5/0 absorbable sutures. Sutures were removed at 2nd week.
Connective tissue graft and coronally advanced flapProcedure or surgery
Control sites were treated by coronally advanced flap (CAF) combined with connective tissue graft (CTG). CAF were used in both treatment arms. Root planning was performed on the exposed part of roots to provide more biocompatible surface for re-attachment. CTG was obtained with single incision method. CTG was positioned at the level of the cemento-enamel junction (CEJ), and sutured on the periosteum bed with 6/0 absorbable sutures. Gingival margins on the flap were placed at least 1 mm coronally of the CEJ and sutured with 5/0 absorbable sutures. Sutures were removed at 2nd week.

Study groups in NCT04942821
Study group	Role	What they receive
Platelet rich fibrin and coronally advanced flap	Experimental	Coronally advanced flap and platelet rich fibrin were used in treatment arms. Receives: Procedure: Platelet rich fibrin and coronally advanced flap
Connective tissue graft and coronally advanced flap	Active comparator	Coronally advanced flap and connective tissue graft were used in treatment arms. Receives: Procedure: Connective tissue graft and coronally advanced flap

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Root Coverage
The percentage of root coverage was calculated according to the preoperative recession depth to postoperative recession depth.
Measured: 12 months

Secondary outcomes (7)

Complete Root Coverage
Complete root coverage was calculated according to measurement of the pre and post operative gingival margin which was above the enamel-sement junction.
Measured: 12 months
Change from Baseline Keratinized Tissue Width at 3 months
Width of keratinized tissue at mid-buccal point measured from free gingival margin to mucogingival junction
Measured: 3 months
Change from Baseline Keratinized Tissue Width at 6 months
Width of keratinized tissue at mid-buccal point measured from free gingival margin to mucogingival junction
Measured: 6 months
Change from Baseline Keratinized Tissue Width at 12 months
Width of keratinized tissue at mid-buccal point measured from free gingival margin to mucogingival junction
Measured: 12 months
Change from Baseline Gingival Thickness at 3 months
Gingival thickness at mid-buccal aspect measured at the center of keratinized tissue.
Measured: 3 months
Change from Baseline Gingival Thickness at 6 months
Gingival thickness at mid-buccal aspect measured at the center of keratinized tissue.
Measured: 6 months
Change from Baseline Gingival Thickness at 12 months
Gingival thickness at mid-buccal aspect measured at the center of keratinized tissue.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Apr 201424 Feb 2017

First posted29 Jun 2021
Study start23 Apr 2014
Primary completion24 Feb 2017
Study completion24 Feb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Root CoverageStudies of the same condition, open and under way.
More trials run by Marmara 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04942821
Sponsor's protocol ID: 22-04-2014/418
Status last verified: Mar 2019
First submitted: 7 Jun 2021
Last updated: 29 Jun 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Yavuz A, Gungormek HS, Kuru L, Dogan B. Treatment of multiple adjacent gingival recessions using leucocyte- and platelet-rich fibrin with coronally advanced flap: a 12-month split-mouth controlled randomized clinical trial. Clin Oral Investig. 2024 May 1;28(5):291. doi: 10.1007/s00784-024-05694-3.
PubMed 38691209

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruiting
Vertically Coronally Advanced Flap Versus Coronally Advanced Flap for Miller Class I Gingival Recession
Gingival Recession
Recruiting
Impact of Root Surface Conditioning With Erythritol Air Polishing and Hand Instrumentation on Recession Coverage Using the Modified Tunnel Technique and Subepithelial Connective Tissue Graft.
Gingival Recession
Recruiting
Influence of Keratinized Tissue Width and Attached Gingiva Width on Root Coverage in Patients With Recession Defects: A Prospective Clinical Study
Gingival Recessions
Not yet recruiting
The Effect of Vertically Coronally Advanced Flap With Sub-epithelial Connective Tissue Graft Versus Coronally Advanced Flap With Sub-epithelial Connective Tissue Graft on Gingival Recession.
Gingival Recession Defects
Active, not recruiting
V-CAF Technique for Miller Class III Gingival Recession
Gingival Recession, Gum Recession

All Root Coverage trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment of Multiple Adjacent Gingival Recessions With Coronally Advanced Flap in Combination With Platelet-Rich Fibrin: A Split-Mouth Study
ClinicalTrials.gov ID: NCT04942821
Acronym / sponsor ID: 22-04-2014/418
Conditions: Root Coverage
Keywords: Gingival recession, Plastic surgery, Platelet rich fibrin, Connective tissue graft, Coronally advanced flap
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Marmara UniversityUniversity, hospital or other
Study start: 23 Apr 2014 (actual)
Primary completion: 24 Feb 2017 (actual)
Study completion: 24 Feb 2017 (actual)
First posted: 29 Jun 2021 (actual)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Platelet rich fibrin and coronally advanced flap	Experimental	Procedure: Platelet rich fibrin and coronally advanced flapCoronally advanced flap and platelet rich fibrin were used in treatment arms.
Connective tissue graft and coronally advanced flap	Active comparator	Procedure: Connective tissue graft and coronally advanced flapCoronally advanced flap and connective tissue graft were used in treatment arms.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patients had at two quadrants, adjacent Miller Class I and at least 2 mm or deeper recessions
Full mouth plaque score 20% and Full mouth bleeding on probing 10%
no active periodontal disease,
involving incisors, canines and premolars,
age ≥ 18 years

Key exclusion criteria (5 listed)

Patients with general diseases which could affect healing process,
smokers
Patients had undergone periodontal surgery during the pervious 24 months on the involved sites,
pregnant or breastfeeding women
endodontic lesions or non-detectable cemento-enamel junctions at experimental teeth

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 fibrin and coronally advanced flapCAF were used in treatment arms. Root planning was performed on the exposed part of roots to provide more biocompatible surface for re-attachment. Two 10 cc tubes with clot activator were used to collect blood from the patient; blood was centrifuged at 2700 rpm for 12 min. PRF box was used to form fibrin clots into membranes. PRF was positioned at the level of the cemento-enamel junction (CEJ), and sutured on the periosteum bed with 6/0 absorbable sutures. Gingival margins on the flap were placed at least 1 mm coronally of the CEJ and sutured with 5/0 absorbable sutures. Sutures were removed at 2nd week.	Procedure or surgery	Platelet rich fibrin and coronally advanced flap
Connective tissue graft and coronally advanced flapControl sites were treated by coronally advanced flap (CAF) combined with connective tissue graft (CTG). CAF were used in both treatment arms. Root planning was performed on the exposed part of roots to provide more biocompatible surface for re-attachment. CTG was obtained with single incision method. CTG was positioned at the level of the cemento-enamel junction (CEJ), and sutured on the periosteum bed with 6/0 absorbable sutures. Gingival margins on the flap were placed at least 1 mm coronally of the CEJ and sutured with 5/0 absorbable sutures. Sutures were removed at 2nd week.	Procedure or surgery	Connective tissue graft and coronally advanced flap

Primary outcome

Percentage of Root Coverage
Time frame: 12 months
The percentage of root coverage was calculated according to the preoperative recession depth to postoperative recession depth.

7 secondary outcomes

Complete Root Coverage
Time frame: 12 months
Change from Baseline Keratinized Tissue Width at 3 months
Time frame: 3 months
Change from Baseline Keratinized Tissue Width at 6 months
Time frame: 6 months
Change from Baseline Keratinized Tissue Width at 12 months
Time frame: 12 months
Change from Baseline Gingival Thickness at 3 months
Time frame: 3 months
Change from Baseline Gingival Thickness at 6 months
Time frame: 6 months
Change from Baseline Gingival Thickness at 12 months
Time frame: 12 months

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 Jun 2021.
Derived from this study: PubMed 38691209Yavuz A, Gungormek HS, Kuru L, Dogan B. Treatment of multiple adjacent gingival recessions using leucocyte- and platelet-rich fibrin with coronally advanced flap: a 12-month split-mouth controlled randomized clinical trial. Clin Oral Investig. 2024 May 1;28(5):291. doi: 10.1007/s00784-024-05694-3.

Related trials for Root Coverage

Active, not recruiting
Vertically Coronally Advanced Flap Versus Coronally Advanced Flap for Miller Class I Gingival Recession
Gingival Recession
Recruiting
Impact of Root Surface Conditioning With Erythritol Air Polishing and Hand Instrumentation on Recession Coverage Using the Modified Tunnel Technique and Subepithelial Connective Tissue Graft.
Gingival Recession
Recruiting
Influence of Keratinized Tissue Width and Attached Gingiva Width on Root Coverage in Patients With Recession Defects: A Prospective Clinical Study
Gingival Recessions
Not yet recruiting
The Effect of Vertically Coronally Advanced Flap With Sub-epithelial Connective Tissue Graft Versus Coronally Advanced Flap With Sub-epithelial Connective Tissue Graft on Gingival Recession.
Gingival Recession Defects
Active, not recruiting
V-CAF Technique for Miller Class III Gingival Recession
Gingival Recession, Gum Recession

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.

Hatice Selin Yıldırım, Dr. study chair

Marmara University, Faculty of Denistry, Department of Periodontology

Başak Doğan, Prof. Dr. study director

Marmara University, Faculty of Denistry, Department of Periodontology

Atacan Yavuz, Dr. principal investigator

Marmara University, Faculty of Denistry, Department of Periodontology

Questions about this trial

What is this clinical trial studying?

A study testing Platelet rich fibrin and coronally advanced flap and Connective tissue graft and coronally advanced flap in people with Root Coverage, run by Marmara 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 5 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 Jun 2021. 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?

Percentage of Root Coverage (time frame: 12 months). 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 NCT04942821, which also lists 1 linked publication.

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 Jun 2021.