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

The University of Alabama at Birmingham

Status: Completed

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

Treatments: Procedure: Acellular Demal Matrix at time of bone graft; Procedure: No soft tissue grafting at time of bone graft; Procedure: Connective tissue graft at time of bone graft

Study type: Interventional

Funder types: Other

Identifiers

NCT03774888

IRB-300002688

Details and patient eligibility

About

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.

Full 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

Enrollment: 24 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

connective tissue graft

Experimental group

Description:

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

Treatment:

Procedure: Connective tissue graft at time of bone graft

Acellular Dermal Matrix

Experimental group

Description:

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

Treatment:

Procedure: Acellular Demal Matrix at time of bone graft

No soft tissue graft (Control)

Active Comparator group

Description:

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.

Treatment:

Procedure: No soft tissue grafting at time of bone graft