Soft Tissue AugmentationNCT06302387
Acellular Dermal Matrix Versus Tenting Technique in Peri-implant Soft Tissue Augmentation and Crestal Bone Stability
A study testing Acellular Dermal Matrix and Soft Tissue Expansion using Tenting Technique in people with Soft Tissue Augmentation, run by Harvard Medical School (HMS and HSDM) at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue Augmentation
- What is being tested?
- Acellular Dermal Matrix and Soft Tissue Expansion using Tenting Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Jan 2018to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Acellular Dermal Matrix Versus Tenting Technique in Peri-implant Soft Tissue Augmentation and Crestal Bone Stability: A Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Soft Tissue Augmentation
- Being tested
- Acellular Dermal Matrix, Soft Tissue Expansion using Tenting Technique
- Keywords
- dental implant, phenotype, mucosal tissues, mucosal tissue augmentation, vertical soft tissue height, bone resorption, bone remodeling
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acellular Dermal MatrixProcedure or surgery
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 TechniqueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Acellular Dermal Matrix | Experimental | This group received vertical soft tissue thickness augmentation using an acellular dermal matrix. Receives: Procedure: Acellular Dermal Matrix |
| Soft Tissue Expansion using Tenting Technique | Experimental | This group underwent soft tissue expansion using a tenting technique with a submerged healing abutment. Receives: Procedure: Soft Tissue Expansion using Tenting Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crestal Bone Levels
Assessment of changes in crestal bone level (CBL)
Measured: Baseline - 1year follow up
Secondary outcomes (4)
Vertical soft tissue thickness
Efficacy of vertical soft tissue thickness augmentation
Measured: Measured from before implant placement to implant uncovering at 2 months
PPD
Pocket probing depth
Measured: Baseline - 1year follow up
BOP
Bleeding on probing
Measured: Baseline - 1year follow up
PI
Plaque Index
Measured: Baseline - 1year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Jan 2018
- Primary completion1 Apr 2020
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue AugmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The interventional study model for this trial is a two-arm, double-blind, randomized, prospective controlled clinical trial.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard Medical School (HMS and HSDM)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, German O. Gallucci, Harvard Medical School (HMS and HSDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302387
- Sponsor's protocol ID
- BEC-LSMU(R)-27
- Status last verified
- Mar 2024
- First submitted
- 21 Feb 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to make de-identified individual participant data (IPD) from our study on dental implant techniques available to other researchers upon request.
Publications
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.
PubMed 29855100Sculean 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.
PubMed 24641001
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Acellular Dermal Matrix Versus Tenting Technique in Peri-implant Soft Tissue Augmentation and Crestal Bone Stability: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06302387
- Acronym / sponsor ID
- BEC-LSMU(R)-27
- Conditions
- Soft Tissue Augmentation
- Keywords
- dental implant, phenotype, mucosal tissues, mucosal tissue augmentation, vertical soft tissue height, bone resorption, bone remodeling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Harvard Medical School (HMS and HSDM)University, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The interventional study model for this trial is a two-arm, double-blind, randomized, prospective controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Acellular Dermal Matrix | Experimental | Procedure: Acellular Dermal MatrixThis group received vertical soft tissue thickness augmentation using an acellular dermal matrix. |
| Soft Tissue Expansion using Tenting Technique | Experimental | Procedure: Soft Tissue Expansion using Tenting TechniqueThis group underwent soft tissue expansion using a tenting technique with a submerged healing abutment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acellular Dermal MatrixThe 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). | Procedure or surgery | Acellular Dermal Matrix |
| Soft Tissue Expansion using Tenting TechniqueThe 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. | Procedure or surgery | Soft Tissue Expansion using Tenting Technique |
Primary outcome
Crestal Bone Levels
Time frame: Baseline - 1year follow up
Assessment of changes in crestal bone level (CBL)
4 secondary outcomes
Vertical soft tissue thickness
Time frame: Measured from before implant placement to implant uncovering at 2 months
PPD
Time frame: Baseline - 1year follow up
BOP
Time frame: Baseline - 1year follow up
PI
Time frame: Baseline - 1year follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Results publication: PubMed 29855100Linkevicius 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.
- Results publication: PubMed 24641001Sculean 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.
- Individual participant dataSharing planned: Yes. We plan to make de-identified individual participant data (IPD) from our study on dental implant techniques available to other researchers upon request.
Related trials for Soft Tissue Augmentation
Recruiting
Evaluating the Barrier Function, Regenerative Capacity, and Soft Tissue Outcomes of Acellular Dermal Matrix
Acellular Dermal Matrix, Bone Grafting
Not yet recruiting
Sandwich vs. Mixed Bone Augmentation for Implant Placement
Peri-implant Bone and Soft Tissues
Not yet recruitingPhase 1/2
Alveolar Ridge Preservation (ARP) Study Using Alloplastic Biomaterial and a Resorbable Synthetic Membrane. A Digital Workflow (CBCT/Scanner) Evaluates Hard and Soft Tissue Volumetric Changes at 4 Months, Validating Support for the Gingival Phenotype and Buccal Bone Plate.
Alveolar Ridge Augmentation, Bone Substitutes
Not yet recruiting
Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
Soft Tissue Augmentation, Gingival Recession Localized Moderate
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Keratinized Tissue Augmentation Using Augmented Gingival Matrix Compared to Free Gingival Graft Around Implants
Keratinized Tissue Augmentation Around Dental Implants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acellular Dermal Matrix and Soft Tissue Expansion using Tenting Technique in people with Soft Tissue Augmentation, run by Harvard Medical School (HMS and HSDM) at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crestal Bone Levels (time frame: Baseline - 1year follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06302387, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.