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

Not Applicable

Completed

• Conditions: Bone Graft; Complications, Infection or Inflammation; Dental Implant; Ridge Deficency
• Interventions: Procedure: No soft tissue grafting at time of bone graft; Procedure: Connective tissue graft at time of bone graft; Procedure: Acellular Demal Matrix at time of bone graft

• Registration Number: NCT03774888
• Lead Sponsor: University of Alabama at Birmingham

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

Study Timeline

• Study First Submitted: 2018-12-11
• Study First Submitted QC: 2018-12-11
• Study First Posted: 2018-12-13
• Study Start: 2019-10-03
• Primary Completion: 2021-05-10
• Study Completion: 2023-07-05
• Status Verified: 2023-11
• Results First Submitted: 2023-11-27
• Results First Submitted QC: 2023-11-27
• Last Update Submitted: 2023-11-27
• Results First Posted: 2024-05-09
• Last Update Posted: 2024-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No soft tissue graft (Control)	No soft tissue grafting at time of bone 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.
connective tissue graft	Connective tissue graft at time of bone 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
Acellular Dermal Matrix	Acellular Demal Matrix at time of bone graft	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

Primary Outcome Measures

Name	Time	Method
Measure Changes Clinically in Crestal Soft Tissue Thickness (in mm)	From baseline to 6 months	The changes in clinical vertical crestal soft tissue thickness by using an endodontic file and periodontal probe.
Measure Changes Digitally in Crestal Soft Tissue Thickness (in mm)	From baseline to 6 months	The changes in soft tissue thickness digitally with superimposition of the intraoral scan and cone-bone computed tomography scan.
Measure Changes Clinically in Soft Tissue Thickness at 4mm Apical From Gingival Margin	From baseline to 6 months	The changes in clinical soft tissue thickness at 4mm apical form the gingival margin by using an endodontic file and periodontal probe.
Measure Changes Digitally in Soft Tissue Thickness at 4mm Apical Form Gingival Margin	From baseline to 6 months	The changes in soft tissue thickness digitally with superimposition of the intraoral scan and cone-bone computed tomography scan.

Trial Locations

Locations (1)

Unversity of Alabama at Birmingham, School of Dentistry; 🇺🇸 Birmingham, Alabama, United States