Clinical Evaluation of Platelet Rich Fibrin Versus Subepithelial Connective Tissue Graft for Soft Tissue Augmentation
1 other identifier
interventional
16
1 country
1
Brief Summary
Soft tissue biotype is a critical factor for success of implant in the esthetic zone . Different soft tissue augmentation techniques have been employed to increase soft tissue thickness such as: autogenous grafts, allografts, xenografts and living cellular construct (LCC). Studies showed that, allografts and xenografts were inferior when compared with autogenous graft . However, few studies were conducted to evaluate the efficacy of soft tissue augmentation with platelet rich fibrin in order to overcome the patient morbidity with SCTG.
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 Aug 2017
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2017
CompletedFirst Posted
Study publicly available on registry
July 18, 2017
CompletedStudy Start
First participant enrolled
August 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedJuly 19, 2017
July 1, 2017
5 months
July 10, 2017
July 17, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Crestal bone resorption
measured mesially and distally using periapical xray in mm
6 months
Study Arms (2)
Platelet Rich Fibrin for soft tissue augmentation
EXPERIMENTALblood will be drawn from the patient vein for PRF. The blood sample will be centrifuged for 10-12 min. PRF membrane is obtained
sub epithelial connective tissue graft
ACTIVE COMPARATORThe connective tissue graft will be harvested from the palate. Then the SCTG will be placed over the recipient site extending palataly and sutured.
Interventions
: Platelet Rich Fibrin for soft tissue augmentation around implant in the aesthetic zone
sub epithelial connective tissue graft for soft tissue augmentation around implant in the aesthetic zone
Eligibility Criteria
You may qualify if:
- Patients with missing maxillary anterior toot teeth.
- Thin gingival biotype.
- Adequate inter-arch space for placement of the implant prosthetic part.
- Good oral hygiene where gingival index is (0, 1) (Loe and Silness 1963).
You may not qualify if:
- Patient with medical condition that is contraindicated with the surgical procedure
- Patients receiving treatment that affect the healing ability.
- Patients with local pathological defects related to the area of interest.
- Smokers or pregnant women.
- Patients with parafunctional habits that may jeopardize the implant longevity and affect the results of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Maymohamedkamal
Cairo, Elmaniel, 11311, 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
- master student
Study Record Dates
First Submitted
July 10, 2017
First Posted
July 18, 2017
Study Start
August 15, 2017
Primary Completion
January 1, 2018
Study Completion
January 1, 2018
Last Updated
July 19, 2017
Record last verified: 2017-07