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

NCT03774888 | Completed Results

• 1 other identifier: IRB-300002688
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• Measure Changes Clinically in Crestal Soft Tissue Thickness (in mm)

  The changes in clinical vertical crestal soft tissue thickness by using an endodontic file and periodontal probe.

  From baseline to 6 months

• Measure Changes Digitally in Crestal Soft Tissue Thickness (in mm)

  The changes in soft tissue thickness digitally with superimposition of the intraoral scan and cone-bone computed tomography scan.

  From baseline to 6 months

• Measure Changes Clinically in Soft Tissue Thickness at 4mm Apical From Gingival Margin

  The changes in clinical soft tissue thickness at 4mm apical form the gingival margin by using an endodontic file and periodontal probe.

  From baseline to 6 months

• Measure Changes Digitally in Soft Tissue Thickness at 4mm Apical Form Gingival Margin

  The changes in soft tissue thickness digitally with superimposition of the intraoral scan and cone-bone computed tomography scan.

  From baseline to 6 months

Study Arms (3)

connective tissue graft

EXPERIMENTAL

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

Procedure: Connective tissue graft at time of bone graft

Acellular Dermal Matrix

EXPERIMENTAL

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

Procedure: Acellular Demal Matrix at time of bone graft

No soft tissue graft (Control)

ACTIVE COMPARATOR

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.

Procedure: No soft tissue grafting at time of bone graft

Interventions

Connective tissue graft at time of bone graft 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

connective tissue graft

Acellular Demal Matrix at time of bone graft 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

Acellular Dermal Matrix

No soft tissue grafting at time of bone graft 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.

No soft tissue graft (Control)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Unversity of Alabama at Birmingham, School of Dentistry

Birmingham, Alabama, 35294-0007, United States

Location

MeSH Terms

Conditions

Infections; Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Randomization was performed by site (dental implant) due to challenges recruiting sufficient participants for all arms.

Results Point of Contact

• Title: Hussein Basma, DDS, MS
• Organization: University of Alabama at Birmingham

basma86@uab.edu

2059344506

Study Officials

• Hussein Basma, DDS, MS

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: December 13, 2018
• Study Start: October 3, 2019
• Primary Completion: May 10, 2021
• Study Completion: July 5, 2023
• Last Updated: May 9, 2024
• Results First Posted: May 9, 2024

Record last verified: 2023-11

Locations

US (1)