Platelet Rich Fibrin in the Treatment of Localized Gingival Recessions
NCT ID: NCT01793389
Last Updated: 2013-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2010-01-31
2011-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Subepithelial connective tissue graft
Soft tissue harvested from palatum of the subjects.
Subepithelial connective tissue graft
Platelet Rich Fibrin
Autogenous platelet and leukocyte fibrin material was obtained from blood.
Platelet Rich Fibrin
Interventions
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Subepithelial connective tissue graft
Platelet Rich Fibrin
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Ege University
OTHER
Responsible Party
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Gülnihal Eren, Research Asisstant
Dr.
Principal Investigators
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Gülnihal Eren, PhD
Role: PRINCIPAL_INVESTIGATOR
Ege University School of Dentistry
Gül Atilla, Professor
Role: STUDY_DIRECTOR
Ege University School of Dentistry
Locations
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Ege University School of Dentistry Department of Periodontology
Izmir, , Turkey (Türkiye)
Countries
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Other Identifiers
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2010-Dis-002
Identifier Type: -
Identifier Source: org_study_id