To Compare Different Soft Tissue Grafts at the Time of Lateral Ridge Augmentation Procedure.

Study Overview
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Brief Summary
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This study will compare two commonly used soft tissue grafting techniques (connective tissue graft, CTG vs Acellular Dermal Matrix, ADM) to augment the soft tissue at the time of lateral ridge augmentation procedure. Following ridge augmentation procedure, most of the times there is a need for soft tissue augmentation to change the quality of the tissue around future implant's site. To our knowledge, the influence of soft tissue augmentation at the time of ridge augmentation procedure has not been tested defects.

Detailed Description
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Research data and daily clinical observations reveal that implants with lack of surrounding keratinized mucosa KM (gingiva-like tissue that normally surrounds natural teeth) are more prone to persistent gingival inflammation, faster disease progression and compromised plaque control. Ridge augmentation procedure can alter the quality of tissue in the sites where it will receive dental implants. Soft tissue grating aims at changing the nature of peri-implant soft tissue by creating or increasing the zone of keratinized mucosa (KM) surrounding implants. CTG or ADM will be grafted at the same time of lateral ridge augmentation procedure. Specific aims for this project include the evaluation of: To evaluate the quality of soft tissue regenerated with the use of the two available soft tissue grafts via histological analysis. To evaluate whether CTG or ADM influences the outcomes of Guided Bone Regeneration (GBR) procedures. To quantify the soft tissue augmentation achieved by the two available soft tissue grafts by direct clinical measurements after the healing

Official Title
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A Randomized Controlled Trial to Compare the Histomorphometric and Clinical Outcomes of Soft Tissue Augmentation at the Time of Lateral Ridge Augmentation Procedures

Conditions
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Bone Graft; Complications, Infection or Inflammation, Ridge Deficency, Dental Implant

Intervention / Treatment
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* Procedure: Connective tissue graft at time of bone graft
* Procedure: Acellular Demal Matrix at time of bone graft
* Procedure: No soft tissue grafting at time of bone graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be a registered University of Alabama at Birmingham (UAB) dental school patient English Speaking Healthy enough to undergo the proposed therapy Demonstrated willingness to comply with study directions and time-line Insufficient alveolar ridge width for endosseous implant placement defined as 5mm or less as determined by bone sounding and cone beam computed tomography (CBCT) scan. Able to read and understand the informed consent form Need for implants to replace missing tooth or teeth in at least one quadrant of the mouth. Exclusion Criteria: No English Speaking Smokers/ tobacco users (>10 cigarettes a day) Less than 18 years old Know hypersensitivity to titanium Patients with significant medical conditions or habbits expected to interfere with bony healing. Patient is a poor compliance risk (i.e., poor oral hygiene, history of alcohol or drug abuse) Bone dehiscence of >4mm following tooth extraction or Vertical loss of bone at edentulous ridge

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: connective tissue graft<br>Connective tissue grafting (CTG) will be placed at the time of lateral ridge augmentation.Following the placement of the bone graft and the membrane, a CTG will be harvested and sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft | Procedure: Connective tissue graft at time of bone graft<br>* following the placement of the bone graft and the membrane, a CTG will be harvested and sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft<br>|
| Experimental: Acellular Dermal Matrix<br>Acellular Dermal matrix (ADM) will be placed at the time of lateral ridge augmentation.Following the placement of the bone graft and the membrane, an ADM will be sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft | Procedure: Acellular Demal Matrix at time of bone graft<br>* following the placement of the bone graft and the membrane, an ADM will be sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft<br>|
| Active Comparator: No soft tissue graft<br>Control group where no soft tissue graft is added to the lateral ridge augmentation.Following the placement of the bone graft and the membrane, the flaps passively sutured on top on the bone. No soft tissue graft will be added. | Procedure: No soft tissue grafting at time of bone graft<br>* Following the placement of the bone graft and the membrane, the flaps passively sutured on top on the bone. No soft tissue graft will be added.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of soft tissue regenerated | Compare the increase in soft tissue quality (attached or keratinized ) between two commonly used soft tissue grafts | From baseline to 6 months | 
| Any influence on the soft tissue outcomes | Compare the amount of bone graft gained when either soft tissue grafts added | From baseline to 6 months | 
| Measure changes in tissue thickness (in mm) between ADM and CTG | Using a periodontal probe, soft tissue thickness will be measured (in mm) and compared between CTG and ADM following soft tissue grafting. | : From baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Keratinized Tissue, Keratinized mucosa, attached mucosa, dental implants, ridge augmentation, guided bone regeneration, connective tissue graft, acellular demral matrix