Soft Tissue Evaluation Around Implants Using Prf or a Palatal Pedicle

Study Overview
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Brief Summary
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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
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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

Official Title
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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
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Soft Tissue Augmentation

Intervention / Treatment
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* Procedure: PRF
* Procedure: Palatal Pedicle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRF with immediate implants<br>Immediate implants placed and covered with two prf layers | Procedure: PRF<br>* soft tissue augmentation by prf<br>|
| Active Comparator: palatal pedicle graft<br>immediate implant placement followed by soft tissue augmentation by oalatal pedicle graft | Procedure: Palatal Pedicle<br>* soft tissue augmentation by palatal pedicle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pink Esthetic Score | photographs | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| facial gingival thickness | probe | 5 months | 
| mid-buccal gingival level | probe | 5 months | 
| interproximal gingival level | probe | 5 months | 
| - width of keratinized gingiva (KG | probe | 5 months | 
| Crestal bone loss | CBCT | 5 months | 
| Implant stability | ostel | 5 months | 
| Pain | VAS | 5 months |