- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03774888
To Compare Different Soft Tissue Grafts at the Time of Lateral Ridge Augmentation Procedure.
A Randomized Controlled Trial to Compare the Histomorphometric and Clinical Outcomes of Soft Tissue Augmentation at the Time of Lateral Ridge Augmentation Procedures
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.
Study Overview
Status
Detailed Description
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294-0007
- Unversity of Alabama at Birmingham, School of Dentistry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: connective tissue graft
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
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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
|
Experimental: Acellular Dermal Matrix
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
|
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
|
Active Comparator: No soft tissue graft
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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
quality of soft tissue regenerated
Time Frame: From baseline to 6 months
|
Compare the increase in soft tissue quality (attached or keratinized ) between two commonly used soft tissue grafts
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From baseline to 6 months
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Any influence on the soft tissue outcomes
Time Frame: From baseline to 6 months
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Compare the amount of bone graft gained when either soft tissue grafts added
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From baseline to 6 months
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Measure changes in tissue thickness (in mm) between ADM and CTG
Time Frame: : From baseline to 6 months
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Using a periodontal probe, soft tissue thickness will be measured (in mm) and compared between CTG and ADM following soft tissue grafting.
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: From baseline to 6 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Hussein Basma, DDS, MS, University of Alabama At Birmingham
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-300002688
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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