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CompletedNCT04942821Updated Jun 29, 2021

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

An interventional study of Platelet rich fibrin and coronally advanced flap and Connective tissue graft and coronally advanced flap in Root Coverage, sponsored by Marmara University. Completed. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-29.

Sponsored by Marmara University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 years 1 month after the study started (first participant enrolled Apr 2014, registered Jun 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

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Conditions studied

  • Root Coverage

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Keywords

  • Gingival recession
  • Plastic surgery
  • Platelet rich fibrin
  • Connective tissue graft
  • Coronally advanced flap
03

In context

Gingival Recession

413 studies on the registry are indexed under Gingival Recession; 98 are open to participants now.

This study's enrollment of 12 is below the median of 30 across 379 interventional studies indexed under Gingival Recession.

Browse Gingival Recession studies →

Lead sponsor

Marmara University is the lead sponsor of 589 studies on the registry; 136 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Platelet rich fibrin and coronally advanced flap

    Coronally advanced flap and platelet rich fibrin were used in treatment arms.

    Procedure: Platelet rich fibrin and coronally advanced flap

  • Active comparator
    Connective tissue graft and coronally advanced flap

    Coronally advanced flap and connective tissue graft were used in treatment arms.

    Procedure: Connective tissue graft and coronally advanced flap

Interventions

  • ProcedurePlatelet rich fibrin and coronally advanced flap

    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.

  • ProcedureConnective tissue graft and coronally advanced flap

    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.

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What researchers measure

Primary outcomes

  1. Percentage of Root Coverage

    The percentage of root coverage was calculated according to the preoperative recession depth to postoperative recession depth.

    Time frame: 12 months

Secondary outcomes

  1. 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.

    Time frame: 12 months

  2. 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

    Time frame: 3 months

  3. 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

    Time frame: 6 months

  4. 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

    Time frame: 12 months

  5. Change from Baseline Gingival Thickness at 3 months

    Gingival thickness at mid-buccal aspect measured at the center of keratinized tissue.

    Time frame: 3 months

  6. Change from Baseline Gingival Thickness at 6 months

    Gingival thickness at mid-buccal aspect measured at the center of keratinized tissue.

    Time frame: 6 months

  7. Change from Baseline Gingival Thickness at 12 months

    Gingival thickness at mid-buccal aspect measured at the center of keratinized tissue.

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2014 to primary completion in Feb 2017, 34 months.

Of 229 non-industry interventional studies with no phase under Gingival Recession, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 31. This study's 34 months is above that.

Counting every sponsor, half of 231 studies reached it within 19 months; a quarter within 11 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 7, 2021
First posted
Jun 29, 2021
StartActual
Apr 23, 2014
Primary completionActual
Feb 24, 2017
CompletionActual
Feb 24, 2017
Last update
Jun 29, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04942821
Lead sponsor
Marmara University
Responsible party
Sponsor
First posted
Jun 29, 2021
Start date
Apr 23, 2014
Primary completion
Feb 24, 2017
Completion
Feb 24, 2017
Last update
Jun 29, 2021

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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