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

NCT ID: NCT01925339

Last Updated: 2019-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2018-03-15

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.

Conditions

Tooth Diseases; Tooth Extraction; Dental Implant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test (immediate restoration)

Test (immediate restoration): immediate restoration will be placed on immediately placed implants.

Group Type: EXPERIMENTAL

Test (immediate restoration)

Intervention Type: DEVICE

Test (immediate restoration)

Control: delayed restoration

Control: delayed restoration: immediate placed implants will be restored at 4 months.

Group Type: EXPERIMENTAL

Control: delayed restoration

Intervention Type: DEVICE

Control: delayed restoration

Interventions

Test (immediate restoration)

Test (immediate restoration)

Intervention Type: DEVICE

Control: delayed restoration

Control: delayed restoration

Intervention Type: DEVICE

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Hom-Lay Wang, DDS, MSD, Ph D

Collegiate Professor of Periodontics and Professor of Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hom-Lay Wang, DDS, MSD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan School of Dentistry

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HUM00070747

Identifier Type: -

Identifier Source: org_study_id