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

NCT03447795 | Completed DMC

• 1 other identifier: 19|01|02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Alveolar Ridge Preservation; Dentin Graft; Autogenous Tooth Bone Graft

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Histological analysis

  after 6 months of grafting

Study Arms (2)

autogenous tooth grafted sites

EXPERIMENTAL

Procedure: Alveolar ridge preservation

autogenous demineralised dentin grafted sites

ACTIVE COMPARATOR

Procedure: Alveolar ridge preservation

Interventions

Alveolar ridge preservation PROCEDURE

grafting procedure using autogenous tooth.

Also known as: ARP

autogenous demineralised dentin grafted sites; autogenous tooth grafted sites

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Ahmed Elfana

Model Details: Randomized controlled clinical trial (RCT) with parallel group, two arm, with 1:1 allocation ratio.

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: February 27, 2018
• Study Start: February 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: June 1, 2020
• Last Updated: November 10, 2020

Record last verified: 2020-11

Locations

EG (1)