Soft Tissue Profile Following Socket Preservation With Platelet Rich Fibrin Versus Free Gingival Graft
Evaluation of the Soft Tissue Profile Following Socket Preservation With Platelet Rich Fibrin Versus Free Gingival Graft: A Randomized Controlled Study
1 other identifier
interventional
26
1 country
1
Brief Summary
Comparing socket preservation with Platelet -Rich Fibrin versus Free gingival graft.
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 Jun 2018
Shorter than P25 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
First Submitted
Initial submission to the registry
May 4, 2018
CompletedStudy Start
First participant enrolled
June 7, 2018
CompletedFirst Posted
Study publicly available on registry
August 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedAugust 14, 2018
May 1, 2018
7 months
May 4, 2018
August 9, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Soft tissue profile change
Optical scanning by optical scanner at baseline to the preoperative cast of the related area, then optical scanning to postoperative cast of the surgical area after 6 months. Then, superimposition between the two scans of the casts will be performed to measure the difference or change in the amount of soft tissue profile measured in millimeters between baseline and at 6 months
6 months
Secondary Outcomes (1)
Crestal bone level change
6 months
Study Arms (2)
PRF (Platelet -rich fibrin) group
EXPERIMENTALExtraction of the tooth followed by Platelet rich fibrin placed in the socket covered bu platelet rich fibrin membrane for socket preservation.
Free gingival graft group
ACTIVE COMPARATORExtraction of the tooth followed by using free gingival graft to cover the socket for socket preservation.
Interventions
platelet rich fibrin will be prepared from patient's venous blood and inserted in the centrifuge at 2000 r.p.m. for 12 minutes Then, the Platelet rich fibrin plug will be placed in the socket after extraction for socket preservation covered by platelet rich fibrin membrane.
Free gingival graft will be taken from the palate to cover the socket after extraction of the tooth for socket preservation.
Eligibility Criteria
You may qualify if:
- Age range 25-50 years.
- Non- restorable teeth indicated for extraction.
- Good oral hygiene.
- Intact facial and lingual plates of bone, without infection or pathosis.
- Adequate apiacl bone for primaru stability
You may not qualify if:
- Presence of uncontrolled Systemic disease eg: diabetes, bone disease or the use of medicines that interfere with bone metabolism, history of head and neck radiotherapy.
- Presence of periodontal and/or periapical infection.
- Smokers.
- Non-compliant patients.
- Pregnancy or lactation in females.
- History of head and neck radiotherapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of Oral and dental medicine, Cairo University
Cairo, 11311 to 11668, Egypt
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle investigator
Study Record Dates
First Submitted
May 4, 2018
First Posted
August 14, 2018
Study Start
June 7, 2018
Primary Completion
January 1, 2019
Study Completion
February 1, 2019
Last Updated
August 14, 2018
Record last verified: 2018-05