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

Not Applicable

Withdrawn

• Conditions: Tooth Loss
• Interventions: Other: Particulate bone graft; Other: Autogenous dental pulp tissue; Other: Suture; Other: Resorbable collagen membrane

• Registration Number: NCT03943849
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2019-05-07
• Study First Submitted QC: 2019-05-07
• Study First Posted: 2019-05-09
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-19
• Last Update Posted: 2022-02-03
• Study Start: 2023-05-01
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Particulate bone graft plus autogenous dental pulp tissue	Particulate bone graft	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.
Particulate bone graft	Suture	Hydrated particulate bone graft will be placed in the debrided extraction socket. The socket will be covered by a resorbable collagen membrane and sutured.
Particulate bone graft plus autogenous dental pulp tissue	Resorbable collagen membrane	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.
Particulate bone graft	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.
Particulate bone graft plus autogenous dental pulp tissue	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.
Particulate bone graft plus autogenous dental pulp tissue	Suture	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.
Particulate bone graft	Resorbable collagen membrane	Hydrated particulate bone graft will be placed in the debrided extraction socket. The socket will be covered by a resorbable collagen membrane and sutured.

Primary Outcome Measures

Name	Time	Method
Bone fill as assessed by radiograph	4 months after placement of bone graft

Secondary Outcome Measures

Name	Time	Method
Extent of mineralization as assessed by von Kossa staining	4 months after placement of bone graft
Extent of mineralization as assessed by Xylenol Orange staining	4 months after placement of bone graft
Expression of osteoblastic marker BSP assessed by immunostaining using anti-BSP antibody	4 months after placement of bone graft
Expression of osteoblastic marker Bglap assessed by quantitative PCR (qPCR)	4 months after placement of bone graft
Expression of osteoblastic marker Bsp assessed by quantitative PCR (qPCR)	4 months after placement of bone graft
Expression of osteoblastic marker BGLAP assessed by immunostaining using anti-BGLAP antibody	4 months after placement of bone graft
Expression of osteoblastic marker DMP1 assessed by immunostaining using anti-DMP1 antibody	4 months after placement of bone graft
Expression of osteoblastic marker Sost assessed by quantitative PCR (qPCR)	4 months after placement of bone graft
Expression of osteoblastic marker Dmp1 assessed by quantitative PCR (qPCR)	4 months after placement of bone graft
Expression of osteoblastic marker Col1a1 assessed by quantitative PCR (qPCR)	4 months after placement of bone graft

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States