Clinical trial NCT06302387: Acellular Dermal Matrix Versus Tenting Technique in Peri-implant Soft Tissue Augmentation and Crestal Bone Stability
Official title: Efficacy of Acellular Dermal Matrix Versus Tenting Technique in Peri-implant Soft Tissue Augmentation and Crestal Bone Stability: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Soft Tissue Augmentation
Keywords: dental implant
phenotype
mucosal tissues
mucosal tissue augmentation
vertical soft tissue height
bone resorption
bone remodeling
Lead sponsor: Harvard Medical School (HMS and HSDM)
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The interventional study model for this trial is a two-arm, double-blind, randomized, prospective controlled clinical trial.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Crestal Bone Levels
timeFrame: Baseline - 1year follow up
Secondary outcomes:
measure: Vertical soft tissue thickness
timeFrame: Measured from before implant placement to implant uncovering at 2 months
measure: PPD
timeFrame: Baseline - 1year follow up
measure: BOP
timeFrame: Baseline - 1year follow up
measure: PI
timeFrame: Baseline - 1year follow up
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: VIC Clinic
Study officials:
References:
citation: 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.
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.