Gum Disease
Conditions
Brief 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.
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.
Interventions
DEVICEDental implant placement
A dental implant will be placed after tooth extraction.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Linear changes of gum tissue architecture | 1 month and 4 months after baseline surgery, 6 months and 12 months after crown delivery | Digitally measured soft tissue changes in mm\^2 using intraoral and CBCT scans |
| Volumetric changes of gum tissue architecture | 1 month and 4 months after baseline surgery, 6 months and 12 months after crown delivery | Digitally measured soft tissue changes in mm\^3 using intraoral and CBCT scans |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in marginal bone | 5 months after baseline surgery, 6 months and 12 months after crown delivery | Digitally measured marginal bone changes from radiographs in mm |
| Patient-reported satisfaction | 14 days after baseline surgery | Percentage of pain reported via post-operative diary |
| Microbial profile | Baseline, 4 months after baseline surgery, 6 months and 12 months after crown delivery | Amount of microbes and immune cells measured as means and medians with standard deviations. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHom-Lay Wang, DDS MSD PhD
Department of Periodontics and Oral Medicine, University of Michigan
Outcome results
None listed