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

Not Applicable
Completed
Conditions
Soft Tissue Augmentation
Interventions
Procedure: Soft Tissue Expansion using Tenting Technique
Procedure: Acellular Dermal Matrix
Registration Number
NCT06302387
Lead Sponsor
Harvard Medical School (HMS and HSDM)
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
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.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Soft Tissue Expansion using Tenting TechniqueSoft Tissue Expansion using Tenting TechniqueThis group underwent soft tissue expansion using a tenting technique with a submerged healing abutment.
Acellular Dermal MatrixAcellular Dermal MatrixThis group received vertical soft tissue thickness augmentation using an acellular dermal matrix.
Primary Outcome Measures
NameTimeMethod
Crestal Bone LevelsBaseline - 1year follow up

Assessment of changes in crestal bone level (CBL)

Secondary Outcome Measures
NameTimeMethod
Vertical soft tissue thicknessMeasured from before implant placement to implant uncovering at 2 months

Efficacy of vertical soft tissue thickness augmentation

PPDBaseline - 1year follow up

Pocket probing depth

PIBaseline - 1year follow up

Plaque Index

BOPBaseline - 1year follow up

Bleeding on probing

Trial Locations

Locations (1)

VIC Clinic

🇱🇹

Vilnius, Lithuania

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