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Platelet Rich Fibrin in the Treatment of Localized Gingival Recessions

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ClinicalTrials.gov Identifier: NCT01793389
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : August 15, 2013
Sponsor:
Information provided by (Responsible Party):
Gülnihal Eren, Research Asisstant, Ege University

Brief Summary:
The present study deals with treatment of localized gingival recessions. The hypothesis of this study is that platelet rich fibrin can be used an alternative to subepithelial connective tissue graft in the coverage of denuded roots. If the platelet rich fibrin will prove to be similarly effective as subepithelial connective tissue graft, it will be possible to avoid a donor site and to decrease patient discomfort after operation.

Condition or disease Intervention/treatment Phase
Gingival Recession Procedure: Subepithelial connective tissue graft Procedure: Platelet Rich Fibrin Not Applicable

Detailed Description:

The main objective of this split-mouth, randomized, controlled clinical trial was to compare the clinical efficacy of platelet rich fibrin (PRF) in combination with the coronally advanced flap (CAF) to the use of subepithelial connective tissue graft (SCTG) in combination with CAF in the treatment of localized gingival recessions.

Primary outcome variables were percentage of complete root coverage and change in gingival recession expressed as recession reduction in millimeters at follow-up visits. The secondary outcome variables included keratinized tissue and gingival thickness gain.

Sample size has been estimated in 22 subjects per treatment groups. Random allocation of the treatment sites to test (CAF+ PRF) and control (CAF + SCTG) groups will be performed using a computerized selection of random numbers for allocation of the study groups.

Periodontal parameters including plaque index (25) (PI), gingival index (26) (GI), probing depth (PD), clinical attachment level (CAL), and gingival recession parameters including recession depth (RD), recession width (RW), recession area (RA), keratinized tissue width (KTW), gingival thickness (GT) were assessed by a calibrated examiner. At baseline and 1, 3 and 6 months, RD, RW, RA, KTW were evaluated by means of both clinical and digital assessment. GI and PI were recorded at baseline and 1, 3 and 6 months, however PD, CAL, and GT were evaluated at baseline and 6 months. PD and CAL were recorded by a Williams probe accurate to the nearest 0.5 mm. GT was evaluated at baseline and 6 months using #15 endodontic reamer attached to a rubber stopper inserted perpendicularly into the gingival tissue 2 mm below the gingival margin; thickness was measured to the nearest 0.1 mm using a caliper.

Clinical images obtained at baseline and 1, 3 and 6 months after surgery from each treatment site and digitized in a computer image analysis system. Using a 4-mm length wire was used to check the reproducibility of the pictures. RD was measured from the cement-enamel junction (CEJ) to the gingival margin, RW was measured tangentially at the mid-facial CEJ, RA was calculated as the area within the contour of denuded root. KTW recorded as the distance from the mucogingival junction (MGJ) to the gingival margin. Duplicate measurements were made for RD, RW, RA and KTW. Percent root coverage and complete root coverage was calculated RA according to the following standard formulae.

Follow-up of subjects will be 6 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Platelet Rich Fibrin in the Treatment of Localized Gingival Recessions: Split-mouth Randomized Clinical Trial
Study Start Date : January 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Arm Intervention/treatment
Active Comparator: Subepithelial connective tissue graft
Soft tissue harvested from palatum of the subjects.
Procedure: Subepithelial connective tissue graft
Experimental: Platelet Rich Fibrin
Autogenous platelet and leukocyte fibrin material was obtained from blood.
Procedure: Platelet Rich Fibrin



Primary Outcome Measures :
  1. Complete root coverage [ Time Frame: 1, 3 and 6 months ]
    Change from baseline in percentage of complete root coverage at 1, 3 and 6 months.

  2. Gingival recession depth [ Time Frame: 1, 3 and 6 months ]
    Change from baseline in gingival recession will be assessed at 1, 3 and 6 months.


Secondary Outcome Measures :
  1. Keratinized tissue width [ Time Frame: 6 months ]
    Change from baseline in keratinized tissue at 6 months.

  2. Gingival thickness [ Time Frame: 6 months ]
    Change from baseline in gingival thickness at 6 months



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Similar bilateral or contralateral Miller Class I or II localized gingival recessions at least ≥ 2 mm located on incisors, canines or premolars on both jaws
  • Identifiable CEJ
  • Age ≥ 18 years
  • Presence of tooth vitality and absence of restorations and superficial caries in the area to be treated
  • No periodontal surgical treatment in the previous 24 months on the involved sites
  • Gingival thickness at least ≥ 0.8 mm for the recession area
  • Sufficient palatal donor tissue for the indicated SCTG.

Exclusion Criteria:

  • Smoking
  • Patients with a pregnancy or lactation period or self-reported history of antibiotic medication within three months
  • Molar, mobile or teeth with crown or filling were also excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793389


Locations
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Turkey
Ege University School of Dentistry Department of Periodontology
İzmir, Turkey, 35100
Sponsors and Collaborators
Ege University
Investigators
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Principal Investigator: Gülnihal Eren, PhD Ege University School of Dentistry
Study Director: Gül Atilla, Professor Ege University School of Dentistry

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Responsible Party: Gülnihal Eren, Research Asisstant, Dr., Ege University
ClinicalTrials.gov Identifier: NCT01793389    
Other Study ID Numbers: 2010-Dis-002
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: August 15, 2013
Last Verified: August 2013
Keywords provided by Gülnihal Eren, Research Asisstant, Ege University:
gingival recession
fibrin
connective tissue
root coverage
microsurgery
case-control studies
Additional relevant MeSH terms:
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Gingival Recession
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy