Dental Implant Clinical Trial
Official title:
A Randomized Controlled Trial to Compare the Histomorphometric and Clinical Outcomes of Soft Tissue Augmentation at the Time of Lateral Ridge Augmentation Procedures
Verified date | December 2022 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 27 |
Est. completion date | November 2023 |
Est. primary completion date | May 10, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: 1. Be a registered University of Alabama at Birmingham (UAB) dental school patient 2. English Speaking 3. Healthy enough to undergo the proposed therapy 4. Demonstrated willingness to comply with study directions and time-line 5. 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. 6. Able to read and understand the informed consent form 7. Need for implants to replace missing tooth or teeth in at least one quadrant of the mouth. Exclusion Criteria: 1. No English Speaking 2. Smokers/ tobacco users (>10 cigarettes a day) 3. Less than 18 years old 4. Know hypersensitivity to titanium 5. Patients with significant medical conditions or habbits expected to interfere with bony healing. 6. Patient is a poor compliance risk (i.e., poor oral hygiene, history of alcohol or drug abuse) 7. Bone dehiscence of >4mm following tooth extraction or Vertical loss of bone at edentulous ridge |
Country | Name | City | State |
---|---|---|---|
United States | Unversity of Alabama at Birmingham, School of Dentistry | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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