Esthetic Outcomes of Immediately Placed Implants Receiving Immediate Provisionalization and Delayed Restoration

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Hsun-Liang Chan, University of Michigan
ClinicalTrials.gov Identifier:
NCT01925339
First received: August 15, 2013
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Tooth Diseases
Device: Test (immediate restoration)
Device: Control: delayed restoration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • mucosal recession [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • radiographic marginal bone level change [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test (immediate restoration)
Test (immediate restoration): immediate restoration will be placed on immediately placed implants.
Device: Test (immediate restoration)
Test (immediate restoration)
Experimental: Control: delayed restoration
Control: delayed restoration: immediate placed implants will be restored at 4 months.
Device: Control: delayed restoration
Control: delayed restoration

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female, aged >18
  • 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
  • Pregnancy or lactating mothers
  • Diseases of the immune system or any medical condition that may influence the treatment outcome (for examples uncontrolled diabetes (HbA1c >7), uncontrolled cardiovascular disease, neurologic or psychiatric disorders, systemic infections, history of radiation therapy in the head and neck area, current use of oral bisphosphonates for >3 years or history of IV bisphosphonates use, current alcoholism or drug abuse etc.)

Intraoral criteria:

  • 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.)
  • Generalized uncontrolled dental diseases, e.g. caries, periodontal diseases, etc.
  • Localized uncontrolled periodontal disease at the study site
  • 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01925339

Contacts
Contact: Andrea Cranston, RDH, BSDH 734-763-3346 acransto@umich.edu

Locations
United States, Michigan
University of Michigan School of Dentistry Not yet recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Husn-Liang Chan, DDS, MS    734-763-3325    hlchan@umich.edu   
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Hsun-Liang Chan, DDS, MS University of Michigan
  More Information

No publications provided

Responsible Party: Hsun-Liang Chan, Clinical Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01925339     History of Changes
Other Study ID Numbers: HUM00070747
Study First Received: August 15, 2013
Last Updated: August 26, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 29, 2014