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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Hom-Lay Wang, DDS, MSD, Ph D, University of Michigan
ClinicalTrials.gov Identifier:
NCT01925339
First received: August 15, 2013
Last updated: August 15, 2016
Last verified: August 2016
  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
Tooth Extraction
Dental Implant
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

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: December 2015
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (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:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

  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: Janet Kinney, RDH, MS 734-763-3346 kinneyj@umich.edu
Contact: Andrea Frantz, RDH, BSDH 734-763-3346 acransto@umich.edu

Locations
United States, Michigan
University of Michigan School of Dentistry Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Janet Kinney, RDH, MS    734-763-3346    kinneyj@umich.edu   
Contact: Andrea Frantz, RDH, BSDH    734-763-3346    acransto@umich.edu   
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Hom-Lay Wang, DDS, MSD, PhD University of Michigan
  More Information

Responsible Party: Hom-Lay Wang, DDS, MSD, Ph D, Collegiate Professor of Periodontics and Professor of Dentistry, University of Michigan
ClinicalTrials.gov Identifier: NCT01925339     History of Changes
Other Study ID Numbers: HUM00070747 
Study First Received: August 15, 2013
Last Updated: August 15, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on December 07, 2016