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

NCT ID: NCT03774888

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-03
• Study Completion Date: 2023-07-05

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Connective tissue graft at time of bone graft

Intervention Type: PROCEDURE

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

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

Group Type: EXPERIMENTAL

Acellular Demal Matrix at time of bone graft

Intervention Type: PROCEDURE

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

No soft tissue graft (Control)

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.

Group Type: ACTIVE_COMPARATOR

No soft tissue grafting at time of bone graft

Intervention Type: PROCEDURE

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.

Interventions

Connective tissue graft at time of bone graft

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

Intervention Type: PROCEDURE

Acellular Demal Matrix at time of bone 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

Intervention Type: PROCEDURE

No soft tissue grafting at time of bone graft

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Hussein Basma

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hussein Basma, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

Unversity of Alabama at Birmingham, School of Dentistry

Birmingham, Alabama, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB-300002688

Identifier Type: -

Identifier Source: org_study_id