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Completed

NCT Number: NCT06302387

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

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.

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Key information

Conditions

Soft Tissue Augmentation Bone Diseases Bone Resorption Musculoskeletal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VIC Clinic

Vilnius, 01362, Lithuania

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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.

Primary outcomes

  1. Crestal Bone Levels

    Time frame: Baseline - 1year follow up

    Assessment of changes in crestal bone level (CBL)

Secondary outcomes

  1. Vertical soft tissue thickness

    Time frame: Measured from before implant placement to implant uncovering at 2 months

    Efficacy of vertical soft tissue thickness augmentation

  2. PPD

    Time frame: Baseline - 1year follow up

    Pocket probing depth

  3. BOP

    Time frame: Baseline - 1year follow up

    Bleeding on probing

  4. PI

    Time frame: Baseline - 1year follow up

    Plaque Index

Sponsors and collaborators

Lead sponsor

Harvard Medical School (HMS and HSDM)

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2023
First posted
Mar 8, 2024
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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