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Clinical Trials/NCT03447795
NCT03447795CompletedNot Applicable

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

Cairo University1 site in 1 country20 target enrollmentStarted: February 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Cone beam computed tomography (CBCT) analysis

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

autogenous tooth grafted sites

Experimental

Intervention: Alveolar ridge preservation (Procedure)

autogenous demineralised dentin grafted sites

Active Comparator

Intervention: Alveolar ridge preservation (Procedure)

Outcomes

Primary Outcomes

Cone beam computed tomography (CBCT) analysis

Time Frame: immediately and after 6 months of grafting

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.

Secondary Outcomes

  • Histological analysis(after 6 months of grafting)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmed Mohamed AbdelRaouf Hussein

Dr. Ahmed Elfana

Cairo University

Study Sites (1)

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