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

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT03447795
Collaborator
(none)
20
1
2
16
1.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Alveolar ridge preservation
N/A

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
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled clinical trial (RCT) with parallel group, two arm, with 1:1 allocation ratio.Randomized controlled clinical trial (RCT) with parallel group, two arm, with 1:1 allocation ratio.
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Alveolar Ridge Preservation Using Autogenous Tooth Graft Versus Autogenous Demineralized Dentin Graft. A Randomized Controlled Clinical Trial.
Actual Study Start Date :
Feb 1, 2019
Actual Primary Completion Date :
Mar 1, 2020
Actual Study Completion Date :
Jun 1, 2020

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Cone beam computed tomography (CBCT) analysis [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 Outcome Measures

    1. Histological analysis [after 6 months of grafting]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cairo University Cairo Egypt

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Mohamed AbdelRaouf Hussein, Dr. Ahmed Elfana, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03447795
    Other Study ID Numbers:
    • 19|01|02
    First Posted:
    Feb 27, 2018
    Last Update Posted:
    Nov 10, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Nov 10, 2020