NCT03774888

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

Completed NA Results posted Last updated 9 May 2024

What this trial tests

NA trial testing Connective tissue graft at time of bone graft in Bone Graft; Complications, Infection or Inflammation in 24 participants. Completed in 5 July 2023.

Timeline

3 October 2019

Primary endpoint
10 May 2021

5 July 2023

Quick facts

Lead sponsor	University of Alabama at Birmingham
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	3 October 2019
Primary completion	10 May 2021
Estimated completion	5 July 2023
Sites	1 location across United States

Drugs / interventions tested

• Connective tissue graft at time of bone graft
• Acellular Demal Matrix at time of bone graft
• No soft tissue grafting at time of bone graft

Conditions studied

• Bone Graft; Complications, Infection or Inflammation — all drugs for Bone Graft; Complications, Infection or Inflammation →
• Ridge Deficency — all drugs for Ridge Deficency →
• Dental Implant — all drugs for Dental Implant →

Sponsor

University of Alabama at Birmingham

Who can join

Adults 18 to 99, any sex, with Bone Graft; Complications, Infection or Inflammation or Ridge Deficency. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Measure Changes Clinically in Crestal Soft Tissue Thickness (in mm) Primary · From baseline to 6 months

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

Group	Value	95% CI
Connective Tissue Graft	1.96	± 1.05
Acellular Dermal Matrix	1.59	± 1.06
No Soft Tissue Graft (Control)	0.33	± 1

Measure Changes Digitally in Crestal Soft Tissue Thickness (in mm) Primary · From baseline to 6 months

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

Group	Value	95% CI
Connective Tissue Graft	1.65	± 0.95
Acellular Dermal Matrix	0.74	± 0.93
No Soft Tissue Graft (Control)	-0.09	± 0.61

Measure Changes Clinically in Soft Tissue Thickness at 4mm Apical From Gingival Margin Primary · 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.

Group	Value	95% CI
Connective Tissue Graft	2.38	± 1.32
Acellular Dermal Matrix	1.37	± 1.2
No Soft Tissue Graft (Control)	0.15	± 1.65

Measure Changes Digitally in Soft Tissue Thickness at 4mm Apical Form Gingival Margin Primary · From baseline to 6 months

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

Group	Value	95% CI
Connective Tissue Graft	1.75	± 0.87
Acellular Dermal Matrix	1.23	± 0.7
No Soft Tissue Graft (Control)	0.71	± 0.57

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.