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

Efficacy of Acellular Dermal Matrix Versus Tenting Technique in Peri-implant Soft Tissue Augmentation and Crestal Bone Stability: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Soft Tissue Augmentation
• Intervention / Treatment: Procedure: Acellular Dermal Matrix; Procedure: Soft Tissue Expansion using Tenting Technique

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lithuania
  • Vilnius, Lithuania, 01362
    • VIC Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acellular Dermal Matrix; This group received vertical soft tissue thickness augmentation using an acellular dermal matrix.	Procedure: Acellular Dermal Matrix; 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).
Experimental: Soft Tissue Expansion using Tenting Technique; This group underwent soft tissue expansion using a tenting technique with a submerged healing abutment.	Procedure: Soft Tissue Expansion using Tenting Technique; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crestal Bone Levels	Assessment of changes in crestal bone level (CBL)	Baseline - 1year follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vertical soft tissue thickness	Efficacy of vertical soft tissue thickness augmentation	Measured from before implant placement to implant uncovering at 2 months
PPD	Pocket probing depth	Baseline - 1year follow up
BOP	Bleeding on probing	Baseline - 1year follow up
PI	Plaque Index	Baseline - 1year follow up

Collaborators and Investigators

• Sponsor: Harvard Medical School (HMS and HSDM)

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: dental implant; phenotype; bone resorption; bone remodeling; mucosal tissues; mucosal tissue augmentation; vertical soft tissue height
• Other Study ID Numbers: BEC-LSMU(R)-27

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We plan to make de-identified individual participant data (IPD) from our study on dental implant techniques available to other researchers upon request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No