Edentulous Alveolar RidgeNCT06302322
Long-term Follow up of Mucosal Tissue Height Influence on Peri-implant Bone Levels.
A study testing Thin Tissues, Thick Tissues and Surgically augmented thin tissues in people with Edentulous Alveolar Ridge, run by Harvard Medical School (HMS and HSDM) at 1 site in Lithuania.
Trial summary
Our study looks into how the thickness of the gum tissue affects the health of the bone around dental implants over ten years. We include 59 people and divide them into three groups based on their gum tissue thickness. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous Alveolar Ridge
- What is being tested?
- Thin Tissues, Thick Tissues and Surgically augmented thin tissues
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteLithuania
- Study dates
- 7 Jan 2021to 1 Oct 2022
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
The inclusion criteria for the study were individuals aged 18 years or older, generally healthy with no medical contraindications for implant surgery, missing teeth in the lower jaw posterior area, at least 6 mm bone width, healthy soft tissue, at least 2 mm keratinized gingiva buccally and lingually, no bone augmentation procedures before or during implant placement, and a signed informed consent form. The exclusion criteria included poor oral hygiene, history of uncontrolled periodontitis, smoking, diabetes, alcoholism, and medication influencing healing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Mucosal Tissue Height on Implant Crestal Bone Stability: A Longitudinal 10-year Cohort Study
Our study looks into how the thickness of the gum tissue affects the health of the bone around dental implants over ten years. We include 59 people and divide them into three groups based on their gum tissue thickness. Some have naturally thin gums, some have thin gums that were made thicker with a special procedure, and some already had thick gums. We try to find out if having thicker gums, whether naturally or through enhancement, can help keep the bone around dental implants healthy in the long run.
Read the detailed description
The protocol of our study focuses on understanding the impact of gum tissue thickness on the stability of the bone surrounding dental implants over a period of ten years. We enroll 59 participants and categorize them based on their initial gum thickness. The study groups included participants with naturally thin gums, participants whose thin gums were surgically enhanced with an allogenic tissue matrix to increase thickness, and participants with naturally thick gums. We monitore the bone levels around the implants using X-rays at baseline and annually, assessing any changes in bone health and stability. Our objective is to determine if and how the thickness of gum tissue influences long-term bone preservation around dental implants, aiming to provide insights into better implant care and outcomes.
- Conditions
- Edentulous Alveolar Ridge
- Being tested
- Thin Tissues, Thick Tissues, Surgically augmented thin tissues
- Keywords
- dental implant, phenotype, mucosal tissues, mucosal tissue augmentation, vertical soft tissue height, bone resorption, bone remodeling, bone formation
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thin TissuesProcedure or surgery
Patients with thin tissues received implants 10 years ago and are now followed up after 10 years.
Thick TissuesProcedure or surgery
Patients with thick tissues received implants 10 years ago and are now followed up after 10 years.
Surgically augmented thin tissuesProcedure or surgery
Patients with thin tissues received soft tissue augmentation and implants 10 years ago and are now followed up after 10 years.
| Study group | Role | What they receive |
|---|---|---|
| Natural Thin Gums | Experimental | Not described Receives: Procedure: Thin Tissues |
| Natural Thick Gums | Experimental | Not described Receives: Procedure: Thick Tissues |
| Surgically augmented Thin Gums | Experimental | Not described Receives: Procedure: Surgically augmented thin tissues |
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: 10 year follow up
Secondary outcomes (3)
PPD
Pocket probing depth
Measured: 10 year follow up
BOP
Bleeding on Probing
Measured: 10 year follow up
PI
Plaque Index
Measured: 10 year 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 start7 Jan 2021
- Primary completion15 Aug 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Edentulous Alveolar RidgeStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 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
- NCT06302322
- Sponsor's protocol ID
- 158200-07-512-149
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 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
Puisys A, Linkevicius T. The influence of mucosal tissue thickening on crestal bone stability around bone-level implants. A prospective controlled clinical trial. Clin Oral Implants Res. 2015 Feb;26(2):123-9. doi: 10.1111/clr.12301. Epub 2013 Dec 9.
PubMed 24313250
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
- Influence of Mucosal Tissue Height on Implant Crestal Bone Stability: A Longitudinal 10-year Cohort Study
- ClinicalTrials.gov ID
- NCT06302322
- Acronym / sponsor ID
- 158200-07-512-149
- Conditions
- Edentulous Alveolar Ridge
- Keywords
- dental implant, phenotype, mucosal tissues, mucosal tissue augmentation, vertical soft tissue height, bone resorption, bone remodeling, bone formation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Harvard Medical School (HMS and HSDM)University, hospital or other
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 1 Oct 2022 (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.
Our study looks into how the thickness of the gum tissue affects the health of the bone around dental implants over ten years. We include 59 people and divide them into three groups based on their gum tissue thickness. Some have naturally thin gums, some have thin gums that were made thicker with a special procedure, and some already had thick gums. We try to find out if having thicker gums, whether naturally or through enhancement, can help keep the bone around dental implants healthy in the long run.
Detailed description
The protocol of our study focuses on understanding the impact of gum tissue thickness on the stability of the bone surrounding dental implants over a period of ten years. We enroll 59 participants and categorize them based on their initial gum thickness. The study groups included participants with naturally thin gums, participants whose thin gums were surgically enhanced with an allogenic tissue matrix to increase thickness, and participants with naturally thick gums. We monitore the bone levels around the implants using X-rays at baseline and annually, assessing any changes in bone health and stability. Our objective is to determine if and how the thickness of gum tissue influences long-term bone preservation around dental implants, aiming to provide insights into better implant care and outcomes.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Natural Thin Gums | Experimental | Procedure: Thin Tissues |
| Natural Thick Gums | Experimental | Procedure: Thick Tissues |
| Surgically augmented Thin Gums | Experimental | Procedure: Surgically augmented thin tissues |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Thin TissuesPatients with thin tissues received implants 10 years ago and are now followed up after 10 years. | Procedure or surgery | Natural Thin Gums |
| Thick TissuesPatients with thick tissues received implants 10 years ago and are now followed up after 10 years. | Procedure or surgery | Natural Thick Gums |
| Surgically augmented thin tissuesPatients with thin tissues received soft tissue augmentation and implants 10 years ago and are now followed up after 10 years. | Procedure or surgery | Surgically augmented Thin Gums |
Primary outcome
Crestal Bone Levels
Time frame: 10 year follow up
Assessment of changes in crestal bone level (CBL)
3 secondary outcomes
PPD
Time frame: 10 year follow up
BOP
Time frame: 10 year follow up
PI
Time frame: 10 year 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.
- Background: PubMed 24313250Puisys A, Linkevicius T. The influence of mucosal tissue thickening on crestal bone stability around bone-level implants. A prospective controlled clinical trial. Clin Oral Implants Res. 2015 Feb;26(2):123-9. doi: 10.1111/clr.12301. Epub 2013 Dec 9.
- 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.
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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 Thin Tissues, Thick Tissues and Surgically augmented thin tissues in people with Edentulous Alveolar Ridge, 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?
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: 10 year 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 NCT06302322, which also lists 1 linked publication.
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.