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

Soft Tissue Augmentation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06302387
• Other study ID #: BEC-LSMU(R)-27
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: February 1, 2023

Study information

• Verified date: March 2024
• Source: Harvard Medical School (HMS and HSDM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 1, 2023
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Soft Tissue Augmentation

Intervention

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).
• 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.

Locations

Country	Name	City	State
Lithuania	VIC Clinic	Vilnius

Sponsors (1)

Lead Sponsor	Collaborator
Harvard Medical School (HMS and HSDM)

Country where clinical trial is conducted

Lithuania, 

References & 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 clinic — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Crestal Bone Levels	Assessment of changes in crestal bone level (CBL)	Baseline - 1year follow up
Secondary	Vertical soft tissue thickness	Efficacy of vertical soft tissue thickness augmentation	Measured from before implant placement to implant uncovering at 2 months
Secondary	PPD	Pocket probing depth	Baseline - 1year follow up
Secondary	BOP	Bleeding on probing	Baseline - 1year follow up
Secondary	PI	Plaque Index	Baseline - 1year follow up