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

A Randomized Controlled Trial to Compare the Histomorphometric and Clinical Outcomes of Soft Tissue Augmentation at the Time of Lateral Ridge Augmentation Procedures

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-0007
      • Unversity of Alabama at Birmingham, School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: 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
Experimental: 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	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
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Hussein Basma, DDS, MS, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2019
• Primary Completion (Actual): May 10, 2021
• Study Completion (Actual): July 5, 2023

Study Registration Dates

• First Submitted: December 11, 2018
• First Submitted That Met QC Criteria: December 11, 2018
• First Posted (Actual): December 13, 2018

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: connective tissue graft; dental implants; Keratinized Tissue; Keratinized mucosa; attached mucosa; ridge augmentation; guided bone regeneration; acellular demral matrix
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: IRB-300002688

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No