Gum DiseaseNCT07732647
Immediate Implant Provisionalization
A study testing Dental implant placement in people with Gum Disease, run by University of Michigan at 1 site in United States.
Trial summary
This research is studying gum tissue stability of dental implants placed at same appointment as the tooth extraction, with or without a provisional (temporary) crown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gum Disease
- What is being tested?
- Dental implant placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2026to 31 Aug 2028
- Phase
- Interventional
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Physical status according to the American Society of Anesthesiology (ASA) I or II, which include patients who are systematically healthy or may suffer from mild to moderate, however well-controlled systemic diseases.
- Periodontally healthy or with treated periodontitis with good oral hygiene ((FMPS) and (FMBS) ≤15%, measured at four sites per tooth).
- Presence of one non-restorable maxillary anterior tooth (from #5 to #12 sites)
- More than 20 occluding teeth with stable occlusion.
- Nonsmokers or smokers < 10 cig/day (self-reported).
Who cannot join
- Presence of uncontrolled or untreated periodontal disease.
- Presence of active periapical infection.
- Subjects taking medications known to modify bone metabolism or those that can interfere with the normal wound healing (such as bisphosphonates, corticosteroids, hormone replacement therapy, parathyroid hormone, denosumab, strontium ranelate, etc.), or those with uncontrolled systemic diseases or conditions that may similarly affect the patient's healing (osteoporosis, osteopenia, hyperparathyroidism, Paget's disease, uncontrolled diabetes (HBA1c > 8)).
- Pregnant subjects or individuals attempting to get pregnant (self-reported)
- Subjects smoking 10 or more cigarettes a day, or those with a history of drug or alcohol abuse (self-reported)
- Subjects unable to maintain adequate oral hygiene
- Insufficient restorative space or bite collapse.
- Lack of primary implant stability assessed intrasurgically.
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
Official title: Soft Tissue Stability of Immediate Implant Placement With and Without Immediate Provisionalization: A Randomized Controlled Clinical Trial
This research is studying gum tissue stability of dental implants placed at same appointment as the tooth extraction, with or without a provisional (temporary) crown.
Read the detailed description
This study aims to find out whether a new type of hybrid dental implant-which has a smooth surface near the gums to make cleaning easier and potentially lower the risk of infection-can help improve gum health and reduce implant complications. It also compares two common treatment approaches after tooth removal: placing a temporary provisional crown immediately versus using a standard healing cap. By studying these options, we hope to learn which method provides better healing, protects the gums more effectively, and leads to fewer problems around the implant.
- Conditions
- Gum Disease
- Being tested
- Dental implant placement
- Medical subject headings
- Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implant placementDevice
A dental implant will be placed after tooth extraction.
| Study group | Role | What they receive |
|---|---|---|
| Provisional crown | Active comparator | A provisional (temporary) crown will be placed on the dental implant after it is placed. Receives: Device: Dental implant placement |
| Healing cap | Active comparator | A healing cap will be placed on the dental implant after it is placed. Receives: Device: Dental implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear changes of gum tissue architecture
Digitally measured soft tissue changes in mm^2 using intraoral and CBCT scans
Measured: 1 month and 4 months after baseline surgery, 6 months and 12 months after crown delivery
Volumetric changes of gum tissue architecture
Digitally measured soft tissue changes in mm^3 using intraoral and CBCT scans
Measured: 1 month and 4 months after baseline surgery, 6 months and 12 months after crown delivery
Secondary outcomes (3)
Changes in marginal bone
Digitally measured marginal bone changes from radiographs in mm
Measured: 5 months after baseline surgery, 6 months and 12 months after crown delivery
Patient-reported satisfaction
Percentage of pain reported via post-operative diary
Measured: 14 days after baseline surgery
Microbial profile
Amount of microbes and immune cells measured as means and medians with standard deviations.
Measured: Baseline, 4 months after baseline surgery, 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 Jul 2026
- Study start19 Jun 2026
- Primary completion1 Jul 2028 (estimated)
- Study completion31 Aug 2028 (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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hom-Lay Wang, DDS, MSD, Ph D, University of Michigan
- Investigators
- Hom-Lay Wang, DDS MSD PhD, Principal investigator, Department of Periodontics and Oral Medicine, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732647
- Sponsor's protocol ID
- HUM00275903
- Status last verified
- Oct 2026
- First submitted
- 23 Jul 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No