Back to resultsEsthetic Outcomes of Immediately Placed Implants Receiving Immediate Provisionalization and Delayed Restoration
Primary Purpose
Tooth Diseases, Tooth Extraction, Dental Implant
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Test (immediate restoration)
Control: delayed restoration
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Diseases
Eligibility Criteria
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
Sites / Locations
- University of Michigan School of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Test (immediate restoration)
Control: delayed restoration
Arm Description
Test (immediate restoration): immediate restoration will be placed on immediately placed implants.
Control: delayed restoration: immediate placed implants will be restored at 4 months.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01925339
First Posted
August 15, 2013
Last Updated
February 12, 2019
Sponsor
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT01925339
Brief Title
Esthetic Outcomes of Immediately Placed Implants Receiving Immediate Provisionalization and Delayed Restoration
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
March 15, 2018 (Actual)
Study Completion Date
March 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Diseases, Tooth Extraction, Dental Implant
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test (immediate restoration)
Arm Type
Experimental
Arm Description
Test (immediate restoration): immediate restoration will be placed on immediately placed implants.
Arm Title
Control: delayed restoration
Arm Type
Experimental
Arm Description
Control: delayed restoration: immediate placed implants will be restored at 4 months.
Intervention Type
Device
Intervention Name(s)
Test (immediate restoration)
Intervention Description
Test (immediate restoration)
Intervention Type
Device
Intervention Name(s)
Control: delayed restoration
Intervention Description
Control: delayed restoration
Primary Outcome Measure Information:
Title
Mucosal Recession Change
Description
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
Secondary Outcome Measure Information:
Title
Radiographic Marginal Bone Level Change
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hom-Lay Wang, DDS, MSD, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan School of Dentistry
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Esthetic Outcomes of Immediately Placed Implants Receiving Immediate Provisionalization and Delayed Restoration
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