Platelet Rich Fibrin in the Treatment of Localized Gingival Recessions
1 other identifier
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 12, 2013
CompletedFirst Posted
Study publicly available on registry
February 15, 2013
CompletedAugust 15, 2013
August 1, 2013
1.8 years
February 12, 2013
August 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Complete root coverage
Change from baseline in percentage of complete root coverage at 1, 3 and 6 months.
1, 3 and 6 months
Gingival recession depth
Change from baseline in gingival recession will be assessed at 1, 3 and 6 months.
1, 3 and 6 months
Secondary Outcomes (2)
Keratinized tissue width
6 months
Gingival thickness
6 months
Study Arms (2)
Subepithelial connective tissue graft
ACTIVE COMPARATORSoft tissue harvested from palatum of the subjects.
Platelet Rich Fibrin
EXPERIMENTALAutogenous platelet and leukocyte fibrin material was obtained from blood.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ege Universitylead
Study Sites (1)
Ege University School of Dentistry Department of Periodontology
Izmir, 35100, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gülnihal Eren, PhD
Ege University School of Dentistry
- STUDY DIRECTOR
Gül Atilla, Professor
Ege University School of Dentistry
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
February 12, 2013
First Posted
February 15, 2013
Study Start
January 1, 2010
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
August 15, 2013
Record last verified: 2013-08