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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acellular Dermal Matrix | Experimental | This group received vertical soft tissue thickness augmentation using an acellular dermal matrix. |
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| Soft Tissue Expansion using Tenting Technique | Experimental | This group underwent soft tissue expansion using a tenting technique with a submerged healing abutment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Crestal Bone Levels | Assessment of changes in crestal bone level (CBL) | Baseline - 1year follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Vertical soft tissue thickness | Efficacy of vertical soft tissue thickness augmentation | Measured from before implant placement to implant uncovering at 2 months |
| PPD | Pocket probing depth |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VIC Clinic | Vilnius | 01362 | Lithuania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29855100 | Result | 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. | |
| 24641001 |
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We plan to make de-identified individual participant data (IPD) from our study on dental implant techniques available to other researchers upon request.
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The interventional study model for this trial is a two-arm, double-blind, randomized, prospective controlled clinical trial.
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double-blind, where neither the patients nor the clinicians responsible for treatment know the specific treatment modality
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| 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. |
|
| Baseline - 1year follow up |
| BOP | Bleeding on probing | Baseline - 1year follow up |
| PI | Plaque Index | Baseline - 1year follow up |
| 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. |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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