Gum DiseaseNCT06185075
Influence of Implant Crown Transmucosal Contour Design on Soft and Hard Tissue Clinical Outcomes
A study testing Implant crown delivery in people with Gum Disease, run by University of Michigan at 1 site in United States.
Trial summary
This study will evaluate how the crown's shape under the gums will influence the gum tissue around dental implants. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gum Disease
- What is being tested?
- Implant crown delivery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2023to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be a current participant of HUM00208140 main study
- Have a dental implant that is ready to be restored (placed at least 3 months ago and healing is adequate)
Who cannot join
- The dental implant crown was already delivered.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Michigan School of Dentistry
Ann Arbor, Michigan, 48109
About this study
This study will evaluate how the crown's shape under the gums will influence the gum tissue around dental implants.
Read the detailed description
This research is studying the transmucosal contour, or shape of crowns (white-colored tooth structure that sits above the gum) under the gums on dental implants. Participants will be randomly selected for the dental implant crown to be designed with either a straight or concave transmucosal contour, and followed up on for 1 year after crown delivery.
- Conditions
- Gum Disease
- Being tested
- Implant crown delivery
- Medical subject headings
- Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant crown deliveryProcedure or surgery
Dental implant crown will be designed, fabricated by a dental lab, and delivered.
| Study group | Role | What they receive |
|---|---|---|
| Straight transmucosal contour | Active comparator | Implant crown will be designed with a straight transmucosal contour Receives: Procedure: Implant crown delivery |
| Concave transmucosal contour | Active comparator | Implant crown will be designed with a concave transmucosal contour Receives: Procedure: Implant crown delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone loss around dental implant
Measured from radiographs in mm
Measured: 6 months and 12 months after crown delivery
Gum tissue thickness
Measured from intraoral scan in mm
Measured: 6 months and 12 months after crown delivery
Gingival margin height
Measured from intraoral scan in mm
Measured: 6 months and 12 months after crown delivery
Amount of keratinized gingiva
Measured clinically in mm
Measured: 6 months and 12 months after crown delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start28 Nov 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gum DiseaseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Saleh, University of Michigan
- Investigators
- Muhammad Saleh, BDS, MSD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185075
- Sponsor's protocol ID
- HUM00208140 Substudy
- Status last verified
- Aug 2026
- First submitted
- 14 Dec 2023
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Implant Crown Transmucosal Contour Design on Soft and Hard Tissue Clinical Outcomes
- ClinicalTrials.gov ID
- NCT06185075
- Acronym / sponsor ID
- HUM00208140 Substudy
- Conditions
- Gum Disease
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 29 Dec 2023 (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 will evaluate how the crown's shape under the gums will influence the gum tissue around dental implants.
Detailed description
This research is studying the transmucosal contour, or shape of crowns (white-colored tooth structure that sits above the gum) under the gums on dental implants. Participants will be randomly selected for the dental implant crown to be designed with either a straight or concave transmucosal contour, and followed up on for 1 year after crown delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Straight transmucosal contour | Active comparator | Procedure: Implant crown deliveryImplant crown will be designed with a straight transmucosal contour |
| Concave transmucosal contour | Active comparator | Procedure: Implant crown deliveryImplant crown will be designed with a concave transmucosal contour |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Be a current participant of HUM00208140 main study
- Have a dental implant that is ready to be restored (placed at least 3 months ago and healing is adequate)
Key exclusion criteria (1 listed)
- The dental implant crown was already delivered.
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 |
|---|---|---|
| Implant crown deliveryDental implant crown will be designed, fabricated by a dental lab, and delivered. | Procedure or surgery | Concave transmucosal contour, Straight transmucosal contour |
Primary outcome
Marginal bone loss around dental implant
Time frame: 6 months and 12 months after crown delivery
Measured from radiographs in mm
Gum tissue thickness
Time frame: 6 months and 12 months after crown delivery
Measured from intraoral scan in mm
Gingival margin height
Time frame: 6 months and 12 months after crown delivery
Measured from intraoral scan in mm
Amount of keratinized gingiva
Time frame: 6 months and 12 months after crown delivery
Measured clinically in mm
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Gum Disease
Recruiting
Thermosensitive Hyaluronic Gel With Octenidine as an Adjunctive to Subgingival Instrumentation
Periodontal Disease
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
Tinnitus, Chronic Subjective Tinnitus
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.
Muhammad Saleh, BDS, MSD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant crown delivery in people with Gum Disease, run by University of Michigan at 1 site in United States.
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 2 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 12 Aug 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Marginal bone loss around dental implant (time frame: 6 months and 12 months after crown delivery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2026.