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

NCT ID: NCT06302387

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2023-02-01

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.

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.

Conditions

Soft Tissue Augmentation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Acellular Dermal Matrix

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

Group Type: EXPERIMENTAL

Acellular Dermal Matrix

Intervention Type: 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).

Soft Tissue Expansion using Tenting Technique

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

Group Type: EXPERIMENTAL

Soft Tissue Expansion using Tenting Technique

Intervention Type: 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.

Interventions

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).

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role: lead

Responsible Party

German O. Gallucci

Associate Professor and Chair Department of Restorative Dentistry and Biomaterials Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

VIC Clinic

Vilnius, , Lithuania

Countries

Lithuania

References

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.

Reference Type: RESULT

PMID: 29855100 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24641001 (View on PubMed)

Other Identifiers

BEC-LSMU(R)-27

Identifier Type: -

Identifier Source: org_study_id