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

Study Overview
=================
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.

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

Conditions
-----------------
Tooth Loss

Intervention / Treatment
-----------------
* Other: Particulate bone graft
* Other: Autogenous dental pulp tissue
* Other: Resorbable collagen membrane
* Other: Suture


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Particulate bone graft plus autogenous dental pulp tissue<br>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<br>* Creos allo.gain allogenic bone particulate mineralized cortical bone will be hydrated and placed in the extraction socket.<br>* Other names: allogenic bone particulates;Other: Autogenous dental pulp tissue<br>* 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.<br>Other: Resorbable collagen membrane<br>* 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.<br>Other: Suture<br>* Resorbable or non-resorbable suture material<br>|
| Active Comparator: Particulate bone graft<br>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<br>* Creos allo.gain allogenic bone particulate mineralized cortical bone will be hydrated and placed in the extraction socket.<br>* Other names: allogenic bone particulates;Other: Resorbable collagen membrane<br>* 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.<br>Other: Suture<br>* Resorbable or non-resorbable suture material<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bone graft, Tooth extraction, Dental pulp