Ridge Preservation Comparing Simultaneous vs. Delayed Grafting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-08

Study Completion Date

2019-04-26

Brief Summary

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Comparison of the clinical healing of simultaneous vs. delayed grafting for dental implant placement.

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Detailed Description

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The primary aims of this study are to compare the clinical and histologic results of a traditional ridge preservation with implant placement at 16 weeks (control group) with early implant placement (8 weeks) with simultaneous contour augmentation as described by Buser (test group).

Conditions

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Tooth Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Delayed Grafting

8 weeks after extraction implant placement and simultaneous osseous grafting.

Group Type EXPERIMENTAL

Delayed graft

Intervention Type PROCEDURE

8 weeks post-extraction 15 test patients will receive implant placement plus osseous grafting.

Simultaneous Grafting

At the time of extraction the socket will be grafted and implant placed 4 months later.

Group Type ACTIVE_COMPARATOR

Simultaneous graft

Intervention Type PROCEDURE

At the time of extraction osseous graft will be placed in the socket and implant placed 4 months later.

Interventions

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Delayed graft

8 weeks post-extraction 15 test patients will receive implant placement plus osseous grafting.

Intervention Type PROCEDURE

Simultaneous graft

At the time of extraction osseous graft will be placed in the socket and implant placed 4 months later.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Have one non-molar maxillary tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by 2 teeth.
* Healthy persons at least 18 years old.
* Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria

* Patients with debilitating systemic disease, or diseases that have a clinically significant effect on the periodontium.
* Exclude any molar tooth.
* Presence of or history of osteonecrosis of jaws.
* Patients with current or previous history of IV bisphosphonates, irrespective of duration.
* Patients taking oral bisphosphonates for ≥ 3 years.
* Pregnant women.
* Allergy to any material or medication used in the study.
* Patients who need prophylactic antibiotics prior to dental procedures.
* Previous head and neck radiation therapy.
* Chemotherapy in the previous 12 months.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes