Clinical trial NCT03774888: To Compare Different Soft Tissue Grafts at the Time of Lateral Ridge Augmentation Procedure.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Graft; Complications, Infection or Inflammation
Ridge Deficency
Dental Implant
Keywords: Keratinized Tissue
Keratinized mucosa
attached mucosa
dental implants
ridge augmentation
guided bone regeneration
connective tissue graft
acellular demral matrix
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2018-12-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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:

1. To evaluate the quality of soft tissue regenerated with the use of the two available soft tissue grafts via histological analysis.
2. To evaluate whether CTG or ADM influences the outcomes of Guided Bone Regeneration (GBR) procedures.
3. To quantify the soft tissue augmentation achieved by the two available soft tissue grafts by direct clinical measurements after the healing

Eligibility criteria: 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

Primary outcomes:
measure: Measure Changes Clinically in Crestal Soft Tissue Thickness (in mm)
timeFrame: From baseline to 6 months
measure: Measure Changes Digitally in Crestal Soft Tissue Thickness (in mm)
timeFrame: From baseline to 6 months
measure: Measure Changes Clinically in Soft Tissue Thickness at 4mm Apical From Gingival Margin
timeFrame: From baseline to 6 months
measure: Measure Changes Digitally in Soft Tissue Thickness at 4mm Apical Form Gingival Margin
timeFrame: From baseline to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Unversity of Alabama at Birmingham, School of Dentistry
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Hussein Basma, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References: