NCT01925339

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2013

Completed
2.3 years until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2018

Completed
11 months until next milestone

Results Posted

Study results publicly available

February 18, 2019

Completed
Last Updated

February 18, 2019

Status Verified

February 1, 2019

Enrollment Period

2.3 years

First QC Date

August 15, 2013

Results QC Date

January 25, 2019

Last Update Submit

February 12, 2019

Conditions

Tooth DiseasesTooth ExtractionDental Implant

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 1 year

Secondary Outcomes (1)

  • Radiographic Marginal Bone Level Change

    Baseline, 1 year

Study Arms (2)

Test (immediate restoration)

EXPERIMENTAL

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

Device: Test (immediate restoration)

Control: delayed restoration

EXPERIMENTAL

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

Device: Control: delayed restoration

Interventions

Test (immediate restoration)DEVICE

Test (immediate restoration)

Test (immediate restoration)
Control: delayed restorationDEVICE

Control: delayed restoration

Control: delayed restoration

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Conditions

Tooth Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Results Point of Contact

Title
Dr. Hom-Lay Wang
Organization
University of Michigan
homlay@umich.edu
734-763-3383

Study Officials

  • Hom-Lay Wang, DDS, MSD, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Collegiate Professor of Periodontics and Professor of Dentistry

Study Record Dates

First Submitted

August 15, 2013

First Posted

August 19, 2013

Study Start

December 1, 2015

Primary Completion

March 15, 2018

Study Completion

March 15, 2018

Last Updated

February 18, 2019

Results First Posted

February 18, 2019

Record last verified: 2019-02

Locations

US(1)