Trial record 6 of 152 for:    Open Studies | "Tooth Diseases"

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 2013 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 16, 2013
Last verified: August 2013
  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.


Condition Intervention
Tooth Diseases
Procedure: Test: Immediate implant restoration
Procedure: Control: Delayed Crown Placement

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 bone gain [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2013
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.
Procedure: Test: Immediate implant restoration
The implant will be restored immediately after the implant is placed.
Experimental: Control: delayed restoration
Control: delayed restoration: immediate placed implants will be restored at 4 months.
Procedure: Control: Delayed Crown Placement
In the control group, the immediately placed implant will be restored at 4 months after the placement procedure.

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 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 1-year after restorations are placed 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. As a second aim, biomarkers related to hard and soft tissue healing will be evaluated.

  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
  • Maxillary premolar, canine, lateral incisor or central incisor with a hopeless prognosis
  • Presence of mild to moderate bony defect on the buccal aspect of the hopeless tooth
  • Presence of sufficient bone height to house a 10mm long implant at the study site
  • Willingness to comply with all study requirements and signing the informed consent

Exclusion Criteria:

  • Area of study adjacent to an existing implant
  • Active acute infection at the extraction site (e.g., sinus tract, swelling)
  • Current heavy smokers (10< cigarettes) or quit smoking less than one year
  • Observable gingival enlargement due to use of medications known to affect the periodontal status (calcium antagonists, anticonvulsives, immunosuppressives, anti-inflammatory medications…)
  • Pregnancy or lactating mothers
  • History of alcoholism or drug abuse
  • Untreated deep carious lesions or defective restorations that can potentially exacerbate during the course of the experiment
  • Diseases of the immune system or any medical condition that may influence the outcome (uncontrolled diabetes (HbA1c >7), neurologic or psychiatric disorders, systemic infections…)
  • Current use of oral bisphosphonates
  • History of IV bisphosphonates use
  • History of radiation therapy in the head and neck area
  • Absence of buccal plate once tooth is extracted or implant is placed
  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 16, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 22, 2014