Dental Implant, Tooth Diseases, Tooth Extraction
Conditions
Brief summary
The purpose of this study is to compare two different timings of restoring dental implants that are placed right after tooth extraction: The test group will have the provisional crown placed at the time of implant placement. The control group will have the tooth removed and the implant placed at the same appointment but restorations placed after 4 months. Both procedures currently are accepted methods for replacing missing teeth but direct comparisons of the two procedures are lacking. The results of this study should aid clinicians in selecting the best timing for restoring implants for their patients. The hypothesis is that immediate restoration might increase aesthetic outcomes, e.g. less mucosal recession.
Detailed description
A single center, randomized controlled, parallel-arm study is planned to investigate esthetic outcomes after immediate placement and restoration in the esthetic zone. Forty adult patients who have a hopeless maxillary anterior or premolar tooth, with intact adjacent teeth will be enrolled. A signed written informed consent will be obtained after he or she has been given verbal and written information describing the nature and duration of the study. Subjects will not be screened or treated until an informed consent has been obtained. Patient information will be protected according to the privacy regulations of the Federal Health Insurance Portability and Accountability Act of 1996 (HIPAA). The enrolled patients will be randomly placed into one of two treatment groups, immediate implant placement (IIP) and restoration group (IR) or the IIP + delayed restoration group (DR). For all patients, the hopeless tooth will be extracted atraumatically and an implant placed immediately. The decision will be made randomly to either restoring the implant immediately (Test group) with a provisional crown or restoring the implant at 4 months after implant placement (Control group). Outcome analyses will be performed until approximately 1-year after the implant surgery and primarily evaluate clinical and radiographic parameters to determine the esthetic outcomes of immediately restored IIP implants, in comparison to those immediately placed but restored in a delayed approach.
Interventions
DEVICETest (immediate restoration)
Test (immediate restoration)
DEVICEControl: delayed restoration
Control: delayed restoration
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or female, aged 21 or older * A minimum dentition of 20 permanent teeth (including natural rooted teeth or dental implants; pontic of a fixed bridge is not considered a tooth) * A maxillary premolar, canine, lateral incisor or central incisor with a hopeless prognosis * Presence of adjacent teeth and enough clearance for an implant crown * Presence of sufficient bone apical to the root apex of the hopeless tooth
Exclusion criteria
Systemic criteria: * Current heavy smokers (\>10 cigarettes per day) or heavy smokers who quitted less than 1 year * Pregnant or plan to get pregnant or lactating mothers * Diseases of the immune system or any medical condition that may influence the outcome (uncontrolled diabetes (HbA1c \>7), neurologic or psychiatric disorders, systemic infections, …) * Radiation therapy in the head and neck area within 3 years * Current use of oral bisphosphonates for \>3 years * History of IV bisphosphonates use * Other medical conditions that may contradict an implant surgery Intraoral criteria: * Area of study is adjacent to an existing implant * Acute infection at/or adjacent to the extraction site (e.g., sinus tract, swelling, etc.) * Observable gingival changes due to use of medications such as calcium antagonists, anticonvulsives, immunosuppressives, anti-inflammatory medications, etc.) * Untreated deep carious lesions or defective restorations that can potentially exacerbate during the course of the experiment * Uncontrolled periodontal disease * Poor oral hygiene (\>20% FMPS) CBCT criteria: • More than 4 mm of buccal plate dehiscence is present on CBCT scans Intraoperative criteria: • More than 4 mm of buccal plate dehiscence is present once the tooth is extracted
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mucosal Recession Change | Baseline, 1 year | Mucosal level change from baseline to one year was primarily determined by an imaginary line connecting the gingival margin of the adjacent teeth. This was measured in millimeters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Marginal Bone Level Change | Baseline, 1 year | Mean of mesial and distal marginal bone level changes measured by standard radiographs using customized device. This was measured in millimeters. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test (Immediate Restoration) Test (immediate restoration): immediate restoration will be placed on immediately placed implants.
Test (immediate restoration): Test (immediate restoration) | 20 |
| Control: Delayed Restoration Control: delayed restoration: immediate placed implants will be restored at 4 months.
Control: delayed restoration: Control: delayed restoration | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
Baseline characteristics
| Characteristic | Test (Immediate Restoration) | Total | Control: Delayed Restoration |
|---|---|---|---|
| Age, Continuous | 61.8 years STANDARD_DEVIATION 12.4 | 59.1 years STANDARD_DEVIATION 13.7 | 57.9 years STANDARD_DEVIATION 15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 20 Participants | 40 Participants | 20 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 20 Participants | 40 Participants | 20 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 20 Participants | 40 Participants | 20 Participants |
| Sex: Female, Male Female | 11 Participants | 21 Participants | 10 Participants |
| Sex: Female, Male Male | 9 Participants | 19 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 13 / 20 | 12 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Mucosal Recession Change
Mucosal level change from baseline to one year was primarily determined by an imaginary line connecting the gingival margin of the adjacent teeth. This was measured in millimeters.
Time frame: Baseline, 1 year
Population: Two subjects withdrew from the study prior to the 1 year time point. Therefore, no data was analyzed for these two subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test (Immediate Restoration) | Mucosal Recession Change | 0.1 milimeters | Standard Deviation 0.9 |
| Control: Delayed Restoration | Mucosal Recession Change | 0.1 milimeters | Standard Deviation 0.7 |
Secondary
Radiographic Marginal Bone Level Change
Mean of mesial and distal marginal bone level changes measured by standard radiographs using customized device. This was measured in millimeters.
Time frame: Baseline, 1 year
Population: Two subjects withdrew from the study prior to the 1 year time point. Therefore, no data was analyzed for these two subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test (Immediate Restoration) | Radiographic Marginal Bone Level Change | 0.8 milimeters | Standard Deviation 0.7 |
| Control: Delayed Restoration | Radiographic Marginal Bone Level Change | 0.8 milimeters | Standard Deviation 0.6 |