The Use of Dental Pulp Tissue as an Autogenous Graft for Ridge Augmentation

NCT ID: NCT03943849

Last Updated: 2022-02-03

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2025-09-01

Brief Summary

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The purpose of this study is to examine and compare the effects of autogenous dental pulp tissue on bone formation in the extraction sockets as compared to commonly used particulate bone graft. The effects on bone formation will be examined using a wide variety of assays.

Detailed Description

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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

DOUBLE

Investigators Outcome Assessors

Study Groups

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Particulate bone graft plus autogenous dental pulp tissue

Dental pulp will be isolated from teeth extracted for non-periodontal reasons chairside. The isolated dental pulp will be mixed with hydrated particulate bone graft, and the mixture will be placed in the debrided extraction socket. The socket will be covered by a resorbable collagen membrane and sutured.

Group Type EXPERIMENTAL

Particulate bone graft

Intervention Type OTHER

Creos allo.gain allogenic bone particulate mineralized cortical bone will be hydrated and placed in the extraction socket.

Autogenous dental pulp tissue

Intervention Type OTHER

Dental pulp will be isolated from teeth extracted for non-periodontal reasons chairside, mixed with hydrated particulate bone graft, and then placed in the extraction socket.

Resorbable collagen membrane

Intervention Type OTHER

After placement of particulate bone graft or particulate bone graft plus autogenous dental pulp tissue, socket will be covered by a resorbable collagen membrane and sutured.

Suture

Intervention Type OTHER

Resorbable or non-resorbable suture material

Particulate bone graft

Hydrated particulate bone graft will be placed in the debrided extraction socket. The socket will be covered by a resorbable collagen membrane and sutured.

Group Type ACTIVE_COMPARATOR

Particulate bone graft

Intervention Type OTHER

Creos allo.gain allogenic bone particulate mineralized cortical bone will be hydrated and placed in the extraction socket.

Resorbable collagen membrane

Intervention Type OTHER

After placement of particulate bone graft or particulate bone graft plus autogenous dental pulp tissue, socket will be covered by a resorbable collagen membrane and sutured.

Suture

Intervention Type OTHER

Resorbable or non-resorbable suture material

Interventions

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Particulate bone graft

Creos allo.gain allogenic bone particulate mineralized cortical bone will be hydrated and placed in the extraction socket.

Intervention Type OTHER

Autogenous dental pulp tissue

Dental pulp will be isolated from teeth extracted for non-periodontal reasons chairside, mixed with hydrated particulate bone graft, and then placed in the extraction socket.

Intervention Type OTHER

Resorbable collagen membrane

After placement of particulate bone graft or particulate bone graft plus autogenous dental pulp tissue, socket will be covered by a resorbable collagen membrane and sutured.

Intervention Type OTHER

Suture

Resorbable or non-resorbable suture material

Intervention Type OTHER

Other Intervention Names

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creos allo.gain allogenic bone particulates

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists (ASA) Physical Status Classification System ASA 1 (A normal healthy patient) or ASA 2 (A patient with mild systemic disease)
* never smoker
* patients with planned tooth extraction
* intact extraction sockets
* no medication or antibiotics intake for at least 6 months prior to the procedure
* patients who gave their consent to participate in the study.

Exclusion Criteria

* vulnerable subjects (children, pregnant and lactating women, patients with learning disabilities, and prisoners)
* inability to obtain pulp tissue (for example, due to previous endodontic therapy, obliterated pulp canals)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Karo Parsegian

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karo Parsegian, DMD, MDSc, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HSC-DB-18-0873

Identifier Type: -

Identifier Source: org_study_id

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