Soft Tissue Augmentation
Conditions
Keywords
dental implant, phenotype, mucosal tissues, mucosal tissue augmentation, vertical soft tissue height, bone resorption, bone remodeling
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.
Interventions
PROCEDUREAcellular 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).
PROCEDURESoft 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.
Sponsors
Harvard Medical School (HMS and HSDM)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
double-blind, where neither the patients nor the clinicians responsible for treatment know the specific treatment modality
Intervention model description
The interventional study model for this trial is a two-arm, double-blind, randomized, prospective controlled clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Crestal Bone Levels | Baseline - 1year follow up | Assessment of changes in crestal bone level (CBL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vertical soft tissue thickness | Measured from before implant placement to implant uncovering at 2 months | Efficacy of vertical soft tissue thickness augmentation |
| PPD | Baseline - 1year follow up | Pocket probing depth |
| BOP | Baseline - 1year follow up | Bleeding on probing |
| PI | Baseline - 1year follow up | Plaque Index |
Countries
Lithuania
Outcome results
None listed