NCT03774888

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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

Conditions

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

Interventions

Type	Name	Description
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
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
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.

Timeline

• Start date: 2019-10-03
• Primary completion: 2021-05-10
• Completion: 2023-07-05
• First posted: 2018-12-13
• Last updated: 2024-05-09
• Results posted: 2024-05-09

Locations

1 site across 1 country: United States