NCT03224442UnknownNot Applicable
Clinical Evaluation of Peri-Implant Soft Tissue Around Immediately Placed Implants Using PRF Membrane Versus The Palatal Pedicle Soft Tissue Graft: A Randomized Controlled Clinical Trial.
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Cairo University
- Enrollment
- 18
- Primary Endpoint
- Pink Esthetic Score
Study Overview
Brief Summary
Clinical Evaluation of Peri-Implant Soft Tissue Around Immediately Placed Implants Using PRF Membrane Versus The Palatal Pedicle Soft Tissue Graft: A Randomized Controlled Clinical Trial.
Detailed Description
Immediate implant will be place and followed by soft tissue augmentation by PRF or palatal pedicle and the primary outcome is the pink esthetic score
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Absence of periodontal disease or a periapical infection
- •Adequate native bone to achieve implant primary stability
- •The need for a single-tooth replacement in the anterior maxilla (from the second bicuspid to the second bicuspid), subsequent to an inevitable tooth extraction.
Exclusion Criteria
- •Systemic conditions/disease that contraindicated surgery
- •Radiation therapy in the head and neck region or chemotherapy during the 12 months prior to surgery.
- •Patients who have any habits that might jeopardize the osseointegration process, such as current smokers.
- •Patients with parafunctional habits that produce overload on implant, such as bruxism and clenching.
- •Patients who have inadequate interarch space for the prosthetic part.
Arms & Interventions
PRF with immediate implants
Experimental
Immediate implants placed and covered with two prf layers
Intervention: PRF (Procedure)
palatal pedicle graft
Active Comparator
immediate implant placement followed by soft tissue augmentation by oalatal pedicle graft
Intervention: Palatal Pedicle (Procedure)
Outcomes
Primary Outcomes
Pink Esthetic Score
Time Frame: 5 months
photographs
Secondary Outcomes
- Crestal bone loss(5 months)
- Implant stability(5 months)
- facial gingival thickness(5 months)
- mid-buccal gingival level(5 months)
- interproximal gingival level(5 months)
- - width of keratinized gingiva (KG(5 months)
- Pain(5 months)
Investigators
Andrew George Edward Aziz
Doctor
Cairo University
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