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

Dental Implant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03774888
• Other study ID #: IRB-300002688
• Status: Completed
• Phase: N/A
• Start date: October 3, 2019
• Est. completion date: July 5, 2023

Study information

• Verified date: November 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 5, 2023
• Est. primary completion date: May 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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
• 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
• 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.

Locations

Country	Name	City	State
United States	Unversity of Alabama at Birmingham, School of Dentistry	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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