N/A
Completed N=24
To Compare Different Soft Tissue Grafts at the Time of Lateral Ridge Augmentation Procedure.
Bone Graft; Complications, Infection or Inflammation · Ridge Deficency · Dental Implant
Source: ClinicalTrials.gov NCT03774888 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
May 2024
Primary outcomePrimary: Measure Changes Clinically in Crestal Soft Tissue Thickness (in mm) — 1.96; 1.59; 0.33 mm
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measure Changes Clinically in Crestal Soft Tissue Thickness (in mm) |
1.96; 1.59; 0.33 | — |
| PRIMARY Measure Changes Digitally in Crestal Soft Tissue Thickness (in mm) |
1.65; 0.74; -0.09 | — |
| PRIMARY Measure Changes Clinically in Soft Tissue Thickness at 4mm Apical From Gingival Margin |
2.38; 1.37; 0.15 | — |
| PRIMARY Measure Changes Digitally in Soft Tissue Thickness at 4mm Apical Form Gingival Margin |
1.75; 1.23; 0.71 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03774888). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.