Alveolar Ridge Preservation Using Autogenous Tooth Graft Versus Autogenous Demineralized Dentin Graft. (ARP)

Alveolar Ridge Preservation Using Autogenous Tooth Graft Versus Autogenous Demineralized Dentin Graft. A Randomized Controlled Clinical Trial.

Alveolar bone resorption following tooth extraction is unavoidable. Graft placement following extraction is recommended when considering restorative procedures afterwards. The extracted tooth was considered a clinical waste. However, it is now seen as a convenient and available source for graft material. Different protocols are applied to process the extracted tooth for obtaining the graft material and investigations are needed to assess the protocol with the best outcome.

Study Overview

• Status: Completed
• Conditions: Alveolar Ridge Preservation; Dentin Graft; Autogenous Tooth Bone Graft
• Intervention / Treatment: Procedure: Alveolar ridge preservation

Detailed Description

Autogenous graft is widely accepted as the gold standard for grafting procedures(Sakkas et al. 2017). And since the introduction of autogenous dentin graft for alveolar ridge preservation by Kim et al. clinically (Y.-K. Kim et al. 2010), it has increasingly attracted attention and teeth are no longer seen only as a waste. Tooth dentin has a chemical composition similar to that of alveolar bone; the inorganic content is 70%-75%, organic content 20%, and water content 10%, whereas alveolar bone has proportions of 65%, 25%, and 10% respectively(Y.-K. Kim et al. 2013). The similarity in chemical composition between dentin and alveolar bone, as well as its content of growth factors such as bone morphogenetic proteins (BMPs), made the dentin a successful graft for filing alveolar bone defects of same patient(Y.-K. Kim et al. 2010, Nampo et al. 2010, Y.-K. Kim et al. 2013) .

The technique proposed by Kim et al includes demineralization of the dentin as it reduces minerals content, exposes collagen fibrils and increases BMPs released thus promoting the process of osteogenesis(Y.-K. Kim et al. 2010). However, demineralisation step is time-consuming, taking several days, which challenges same visit application. As a result, two main approaches have been developed to overcome this obstacle. One approach is to maintain the demineralization step but with improving the technique to shorten the processing time(MURATA et al. 2010, E.-S. Kim 2015, Kabir et al. 2015). On the other hand, many investigators have used the whole tooth without demineralization and reported satisfactory clinical outcome(Gideon Hallel et al. 2014, Valdec et al. 2017). Hence, more investigations are needed to evaluate the technique with the best outcome.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

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:

• Patients with non-restorable non-molar teeth
• Patients > 18 years old
• Motivated patients who are willing to continue the follow-up period

Exclusion Criteria:

• Compromised alveolar socket that is not contained to support graft material
• smokers and alcoholic patients.
• Patients with systemic conditions that may compromise hard tissue healing (i.e. poorly controlled diabetes, autoimmune diseases).
• Local infection at the site of extraction.
• Teeth with root canal filling.

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: autogenous tooth grafted sites	Procedure: Alveolar ridge preservation; grafting procedure using autogenous tooth.; Other Names: ARP
Active Comparator: autogenous demineralised dentin grafted sites	Procedure: Alveolar ridge preservation; grafting procedure using autogenous tooth.; Other Names: ARP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cone beam computed tomography (CBCT) analysis	CBCT scans will be taken at first day and at 6 months after the grafting procedures. The scans will be compared using predetermined reference points, buccolingual and vertical dimensions will be measured in cross-sectional images using the same reference points and lines. The difference in mm will be subtracted.	immediately and after 6 months of grafting

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histological analysis	Bone samples from at least one control and one intervention site will be taken during implant placement. Patients will be asked to sign and additional informed consent. A trephine bur will be used to obtain samples and then sent to the department of oral histology for assessment	after 6 months of grafting

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: February 15, 2018
• First Submitted That Met QC Criteria: February 26, 2018
• First Posted (Actual): February 27, 2018

Study Record Updates

• Last Update Posted (Actual): November 10, 2020
• Last Update Submitted That Met QC Criteria: November 6, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 19|01|02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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