Ridge Preservation Using Different Techniques

Study Overview
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Brief Summary
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Soft tissue contour and radiographic evaluation of alveolar ridge preservation using different techniques Background: Following tooth extraction, the alveolar ridge undergoes an inevitable remodeling process which influences future implant therapy or prosthetic rehabilitation in the edentulous area. In an attempt to attenuate the loss of hard and soft tissue after tooth loss, alveolar ridge preservation (ARP) immediately after complete tooth extraction could minimize the need for ancillary ridge augmentation or soft tissue grafting. Different techniques and barrier membranes has been proposed to achieve the sealing of extraction socket. Aim: To investigate the effect of different techniques and barrier membranes for the soft tissue contour and morphological change of alveolar ridge after ARP Methods: The study was designed as a randomized controlled trial and recruited patients, who require ARP for the purpose of implant placement or prosthodontic rehabilitation. After the tooth extraction, patients were randomly allocated to one of the following groups: ridge preservation with a xenogeneic bone substitute and (a) spontaneous healing (control), (b) covered with a free palatal graft, (c) or covered with pedical palatal graft, (d) covered with a collagen membrane, (e) covered with a non-resorbable high-density polytetrafluoroethylene membrane. 2 weeks, 4 weeks, 12 weeks, and 24 weeks following tooth extraction and ARP, clinical profilometric and radiographic evaluations were performed to analyze the change of hard and soft tissue contour. Moreover, and the need for additional guided bone regeneration (GBR) or soft tissue augmentation were assessed prior implants or fixed prosthesis placement.

Official Title
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Soft Tissue Contour and Radiographic Evaluation of Ridge Preservation Using Different Techniques

Conditions
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Alveolar Ridge Augmentation, Connective Tissue, Tooth Extraction, Membranes; Retained

Intervention / Treatment
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* Procedure: Alveolar ridge preservation
* Procedure: Alveolar ridge preservation
* Procedure: Alveolar ridge preservation
* Procedure: Alveolar ridge preservation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >20 years old No contraindications for invasive dental procedures. Not pregnant. Teeth need to be extracted due to malocclusion or broken teeth. Requires dental implant or denture fabrication after tooth extraction. Healthy soft tissue (probing bleeding index <20%, plaque index <20%). At least 2mm of keratinized gingiva on the buccal and lingual sides. No need for simultaneous bone augmentation surgery during implant placement. Willing to participate in and sign the consent form for this trial. Exclusion Criteria: Poor oral hygiene maintenance. Uncontrolled periodontal disease. Heavy smoker (smokes >20 cigarettes per day). Uncontrolled diabetes. Alcohol abuse. Currently receiving medication treatment affecting wound healing (osteoporosis medication, radiation or chemotherapy).

Ages Eligible for Study
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Minimum Age: 20 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
Interventional Model Description: spontaneous healing (control) Alveolar ridge preservation grafted with bone particle and covered with a free palatal graft covered with pedical palatal graft covered with a collagen membrane covered with a non-resorbable high-density polytetrafluoroethylene membrane.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: spontaneous healing<br>No treatment after tooth extraction | |
| Experimental: Bone particle + subepithelial connective tissue graft<br>Alveolar ridge preservation grafted with bone particle and covered with a subepithelial connective tissue graft | Procedure: Alveolar ridge preservation<br>* grafted with bone particle and covered with a subepithelial connective tissue graft<br>Procedure: Alveolar ridge preservation<br>* grafted with bone particle and covered with vascularized interpositional periosteal connective tissue graft<br>Procedure: Alveolar ridge preservation<br>* grafted with bone particle and covered with a collagen membrane<br>Procedure: Alveolar ridge preservation<br>* grafted with bone particle and covered with a Cytoplast<br>|
| Experimental: Bone particle + Vascularized interpositional periosteal connective tissue graft<br>Alveolar ridge preservation grafted with bone particle and covered with vascularized interpositional periosteal connective tissue graft | Procedure: Alveolar ridge preservation<br>* grafted with bone particle and covered with a subepithelial connective tissue graft<br>Procedure: Alveolar ridge preservation<br>* grafted with bone particle and covered with vascularized interpositional periosteal connective tissue graft<br>Procedure: Alveolar ridge preservation<br>* grafted with bone particle and covered with a collagen membrane<br>Procedure: Alveolar ridge preservation<br>* grafted with bone particle and covered with a Cytoplast<br>|
| Experimental: Bone particle + collagen membrane<br>Alveolar ridge preservation grafted with bone particle and covered with a collagen membrane | Procedure: Alveolar ridge preservation<br>* grafted with bone particle and covered with a subepithelial connective tissue graft<br>Procedure: Alveolar ridge preservation<br>* grafted with bone particle and covered with vascularized interpositional periosteal connective tissue graft<br>Procedure: Alveolar ridge preservation<br>* grafted with bone particle and covered with a collagen membrane<br>Procedure: Alveolar ridge preservation<br>* grafted with bone particle and covered with a Cytoplast<br>|
| Experimental: Bone particle + Cytoplast<br>Alveolar ridge preservation grafted with bone particle and covered with a Cytoplast. | Procedure: Alveolar ridge preservation<br>* grafted with bone particle and covered with a subepithelial connective tissue graft<br>Procedure: Alveolar ridge preservation<br>* grafted with bone particle and covered with vascularized interpositional periosteal connective tissue graft<br>Procedure: Alveolar ridge preservation<br>* grafted with bone particle and covered with a collagen membrane<br>Procedure: Alveolar ridge preservation<br>* grafted with bone particle and covered with a Cytoplast<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Soft tissue alternation | cone-beam computed tomography data and STereoLithography files are superimposed to measure the soft tissue dimensions. | up to 12 months | 
| Hard tissue alternation | cone-beam computed tomography data and STereoLithography files are superimposed to measure the hard tissue dimensions. | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Keratinized tissue width changes | Use periodontal probe to measurement. | up to 12 months | 
| Visual Analogue Scale | Ask the patient to fill out the questionnaire | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alveolar Ridge Preservation Connective tissue graft, Tooth extraction, Membranes