Acellular Dermal Matrix Versus Tenting Technique in Peri-implant Soft Tissue Augmentation and Crestal Bone Stability

Harvard Medical School (HMS and HSDM)

Status

Completed

Conditions

Soft Tissue Augmentation

Treatments

Procedure: Soft Tissue Expansion using Tenting Technique

Procedure: Acellular Dermal Matrix

Study type

Interventional

Funder types

Other

Identifiers

NCT06302387

BEC-LSMU(R)-27

Details and patient eligibility

About

This study looks at two ways to make gums thicker and bones stable around dental implants for people with thin gums. It compares two methods in 40 people: one method uses a special graft, and the other uses a technique called tenting. The goal is to see which method might work better for making the gums and bones around implants healthier. The check-ups are planned when the implant is put in and again after one year. The study focuses on how these methods are done without talking about what the results are.

Full description

The study's protocol entails a randomized comparison between acellular dermal matrix grafting and the tenting technique, aimed at enhancing gum thickness and bone stability around dental implants in individuals with thin gum profiles. Forty participants are systematically assigned to one of the two methods under investigation. The study is structured to evaluate the interventions' potential in improving conditions conducive to the success of dental implants, specifically targeting soft tissue thickness and crestal bone level stability. The comprehensive investigation is designed to explore effective approaches for managing patients with particular soft tissue challenges, focusing on the clinical application and procedural aspects without presenting any results or conclusions.

Enrollment

40 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male and female patients between 18-75 years old.
Physical and psychological capacity to undergo implant therapy (ASA I or II).
Fully healed single mandibular posterior treatment sites (premolars or molars) being edentulous for at least 3 months.
Minimum of 6 mm width and 8 mm height native bone ridge.
No requirement for concomitant or a history of regenerative treatments.
Minimum of 4mm keratinized mucosa at the implant site (2 mm buccal and 2mm lingual).
Healthy non-inflamed keratinized soft tissues with a maximum soft tissue thickness height of 2 mm measured at crestal buccal and lingual aspects.
Periodontally healthy by fulfilling all of the following criteria: Full-mouth bleeding score (FMBS) < 20%, Full-mouth plaque score (FMPS) < 15%, Community Periodontal Index of Treatment Needs (CPITN) < 2.

Exclusion criteria

Patients with a history of periodontitis.
Poor oral hygiene after Oral Hygiene Instructions (OHI).
Pregnant or lactating.
Uncontrolled concomitant medical diseases, e.g., diabetes.
Receiving or having received pharmacological treatment affecting wound healing within 3 months prior to the study-related intervention.