NCT00067392

Brief Summary

The purpose of this study is to determine the difference in success when placing implants immediately into an extraction site compared to delaying the implant placement until the extraction site has healed. In addition, the level of bone around the implants will be compared to determine if one method leads to better results over time.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2003

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2003

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 20, 2003

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2003

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

November 9, 2010

Status Verified

July 1, 2008

Enrollment Period

4.4 years

First QC Date

August 15, 2003

Last Update Submit

November 8, 2010

Conditions

Dental Caries

Keywords

Partial edentulismBone atrophyBone healing

Outcome Measures

Primary Outcomes (1)

  • Crestal bone levels adjacent to the implants

    4 months

Secondary Outcomes (1)

  • Position of the papillary complex and facial gingival margin, and indicator of the inflammatory state of the perimplant tissues.

    4 months

Interventions

Dental ImplantPROCEDURE

Dental Implant 4 month time frame

Eligibility Criteria

Age21 Months - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients will be willing to be present for examination two times a year for at least three years, as well as maintenance cleanings twice a year 3 months prior to the data collection visit.
  • All patients will be free of uncontrolled diabetes (any type), existing malignancy, and will not be receiving any therapy that suppresses their immune system, such as radiation, chemotherapy, or chronic steroid usage
  • Need for extraction of a single rooted maxillary central or lateral incisor, canine, or premolar, with no signs of acute infection (purulent exudate, erythema, pain, and swelling).
  • Patients will have bone present on all surfaces of the tooth within 3 mm of the gingival margin of the planned restoration, in order to provide sufficient bone to circumferentially cover the implant.
  • All patients will have adequate space for satisfactory restoration of the edentulous space.
  • Each patient's dentition will be free of active periodontal disease or exhibit controllable periodontal disease such that their teeth will clinically be non-mobile and have probing depths less than 3 mm.
  • All prospective sites will have at least 2mm of attached or keratinized gingiva.
  • The crestal bone width should be enough to accommodate either a 3.75 diameter implant for the central incisor, canine, and premolar sites, or a 3.25 mm diameter implant for the lateral incisor tooth sites. Bone height should be at least 14 mm for accommodation of the implant.

You may not qualify if:

  • Patients with labial dehiscence defects greater than 3 mm from the proposed gingival margin of the planned restoration will be excluded from this study.
  • Patients who cannot come for follow up due to conflicts of schedules will not be accepted into the study.
  • Patients with advanced cardiovascular, pulmonary, renal, liver disease that place them in an ASA III or IV rating will be excluded. Post-menopausal women with known osteoporosis as determined by their medical internist, will be excluded. Patients with known alcohol abuse will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LSU School of Dentistry

New Orleans, Louisiana, 70119, United States

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Dental Implants

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental MaterialsBiomedical and Dental MaterialsDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Michael S Block, DMD, Ph.D

    LSU School of Dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 15, 2003

First Posted

August 20, 2003

Study Start

November 1, 2003

Primary Completion

April 1, 2008

Study Completion

May 1, 2009

Last Updated

November 9, 2010

Record last verified: 2008-07

Locations

US(1)