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

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.

Study Overview

• Status: Withdrawn
• Conditions: Tooth Loss
• Intervention / Treatment: Other: Particulate bone graft; Other: Autogenous dental pulp tissue; Other: Resorbable collagen membrane; Other: Suture

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Particulate bone graft; Creos allo.gain allogenic bone particulate mineralized cortical bone will be hydrated and placed in the extraction socket.; Other Names: creos allo.gain; allogenic bone particulates; 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.; 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.; Other: Suture; Resorbable or non-resorbable suture material
Active Comparator: 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.	Other: Particulate bone graft; Creos allo.gain allogenic bone particulate mineralized cortical bone will be hydrated and placed in the extraction socket.; Other Names: creos allo.gain; allogenic bone particulates; 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.; Other: Suture; Resorbable or non-resorbable suture material

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bone fill as assessed by radiograph	immediately after placement of bone graft
Bone fill as assessed by radiograph	2 months after placement of bone graft
Bone fill as assessed by radiograph	4 months after placement of bone graft

Secondary Outcome Measures

Outcome Measure	Time Frame
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 quantitative PCR (qPCR)	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 BGLAP assessed by immunostaining using anti-BGLAP antibody	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 DMP1 assessed by immunostaining using anti-DMP1 antibody	4 months after placement of bone graft
Expression of osteoblastic marker Col1a1 assessed by quantitative PCR (qPCR)	4 months after placement of bone graft
Expression of osteoblastic marker Sost assessed by quantitative PCR (qPCR)	4 months after placement of bone graft

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Karo Parsegian, DMD, MDSc, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): September 1, 2025
• Study Completion (Anticipated): September 1, 2025

Study Registration Dates

• First Submitted: May 7, 2019
• First Submitted That Met QC Criteria: May 7, 2019
• First Posted (Actual): May 9, 2019

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: January 19, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Bone graft; Tooth extraction; Dental pulp
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Tooth Loss
• Other Study ID Numbers: HSC-DB-18-0873

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No