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

Tooth Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03943849
• Other study ID #: HSC-DB-18-0873
• Status: Withdrawn
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: September 1, 2025

Study information

• Verified date: January 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Tooth Loss

Intervention

Other:
• Particulate bone graft
Creos allo.gain allogenic bone particulate mineralized cortical bone will be hydrated and placed in the extraction socket.
• 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.
• 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.
• Suture
Resorbable or non-resorbable suture material

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone fill as assessed by radiograph		immediately after placement of bone graft
Primary	Bone fill as assessed by radiograph		2 months after placement of bone graft
Primary	Bone fill as assessed by radiograph		4 months after placement of bone graft
Secondary	Extent of mineralization as assessed by von Kossa staining		4 months after placement of bone graft
Secondary	Extent of mineralization as assessed by Xylenol Orange staining		4 months after placement of bone graft
Secondary	Expression of osteoblastic marker Bsp assessed by quantitative PCR (qPCR)		4 months after placement of bone graft
Secondary	Expression of osteoblastic marker BSP assessed by immunostaining using anti-BSP antibody		4 months after placement of bone graft
Secondary	Expression of osteoblastic marker Bglap assessed by quantitative PCR (qPCR)		4 months after placement of bone graft
Secondary	Expression of osteoblastic marker BGLAP assessed by immunostaining using anti-BGLAP antibody		4 months after placement of bone graft
Secondary	Expression of osteoblastic marker Dmp1 assessed by quantitative PCR (qPCR)		4 months after placement of bone graft
Secondary	Expression of osteoblastic marker DMP1 assessed by immunostaining using anti-DMP1 antibody		4 months after placement of bone graft
Secondary	Expression of osteoblastic marker Col1a1 assessed by quantitative PCR (qPCR)		4 months after placement of bone graft
Secondary	Expression of osteoblastic marker Sost assessed by quantitative PCR (qPCR)		4 months after placement of bone graft