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

NCT06302387 | Completed

• 1 other identifier: BEC-LSMU(R)-27
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Soft Tissue Augmentation

Keywords

dental implant; phenotype; mucosal tissues; mucosal tissue augmentation; vertical soft tissue height; bone resorption; bone remodeling

Outcome Measures

Primary Outcomes (1)

• Crestal Bone Levels

  Assessment of changes in crestal bone level (CBL)

  Baseline - 1year follow up

Secondary Outcomes (4)

• Vertical soft tissue thickness

  Measured from before implant placement to implant uncovering at 2 months

• PPD

  Baseline - 1year follow up

• BOP

  Baseline - 1year follow up

• PI

  Baseline - 1year follow up

Study Arms (2)

Acellular Dermal Matrix

EXPERIMENTAL

This group received vertical soft tissue thickness augmentation using an acellular dermal matrix.

Procedure: Acellular Dermal Matrix

Soft Tissue Expansion using Tenting Technique

EXPERIMENTAL

This group underwent soft tissue expansion using a tenting technique with a submerged healing abutment.

Procedure: Soft Tissue Expansion using Tenting Technique

Interventions

Acellular Dermal Matrix PROCEDURE

The ADM arm involved vertical soft tissue augmentation using an acellular dermal matrix. This process included the placement of a porcine dermal collagen graft (Mucoderm®, Institut Straumann AG, Switzerland) atop the dental implant site. The graft, measuring 15x20 mm, was hydrated in a 0.5% Metronidazole solution for 20 minutes before application, then trimmed and placed to extend 10 by 5 mm beyond the implant margins in both buccal and lingual directions. The primary wound closure was achieved using double mattress suturing with 6-0 Prolene (Ethicon, USA).

Acellular Dermal Matrix

Soft Tissue Expansion using Tenting Technique PROCEDURE

The Tenting Technique arm involved soft tissue expansion using a submerged healing abutment to promote soft tissue growth. After implant placement, 2 mm healing abutments were set on the implants. Flaps were mobilized using vertical releasing incisions, and tension-free wound closure was achieved with horizontal mattress sutures followed by suturing the incision line with interrupted sutures for primary and submerged healing. This method aimed to create a subepithelial healing space for soft tissue expansion and augmentation.

Soft Tissue Expansion using Tenting Technique

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harvard Medical School (HMS and HSDM): lead

Study Sites (1)

VIC Clinic

Vilnius, 01362, Lithuania

Location

Related Publications (2)

• Linkevicius T, Linkevicius R, Alkimavicius J, Linkeviciene L, Andrijauskas P, Puisys A. Influence of titanium base, lithium disilicate restoration and vertical soft tissue thickness on bone stability around triangular-shaped implants: A prospective clinical trial. Clin Oral Implants Res. 2018 Jul;29(7):716-724. doi: 10.1111/clr.13263. Epub 2018 May 31.

  PMID: 29855100 RESULT

• Sculean A, Gruber R, Bosshardt DD. Soft tissue wound healing around teeth and dental implants. J Clin Periodontol. 2014 Apr;41 Suppl 15:S6-22. doi: 10.1111/jcpe.12206.

  PMID: 24641001 RESULT

MeSH Terms

Conditions

Bone Resorption

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: double-blind, where neither the patients nor the clinicians responsible for treatment know the specific treatment modality
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Chair Department of Restorative Dentistry and Biomaterials Sciences

Model Details: The interventional study model for this trial is a two-arm, double-blind, randomized, prospective controlled clinical trial.

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 8, 2024
• Study Start: January 1, 2018
• Primary Completion: April 1, 2020
• Study Completion: February 1, 2023
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

LI (1)