Effect of Autogenous Demineralized Dentin as a Bone Graft Substitute in Management of Periodontal Intrabony Defects

Clinical and Radiographic Effect of Extracted Autogenous Demineralized Dentin as a Bone Graft Substitute in Management of Periodontal Intrabony Defects: A Case Series

one of the ultimate goals in periodontology is to achieve periodontal regeneration and change the prognosis of questionable or hopeless teeth to maintainable.Bone substitutes have been actively used to reconstruct bony defects. Four categories of bone graft materials exist: Autograft, Allograft, Alloplast, and Xenograft.many researchers paid attention to human tooth as one of the intraoral donor sites due to the chemical and structural similarity between dentin and alveolar bone since both demonstrate low crystalline hydroxyl appetite (HA) with comparable calcium-to-phosphorus ratio.

Extracted tooth will be cleaned from periodontal ligaments, cementum, soft tissue attachment, caries, or restorations (if present), using a high-speed fine finishing stone and saline irrigation. The pulp chamber will be cleaned with sterile endodontic files. Subsequently, teeth will be grounded, using hand bone mill .

ADDG particles prepared by demineralization of tooth particles in 0.6N hydrochloric acid for 30 min to achieve demineralized then washed twice in saline and dried with sterile gauze. The intrabony defect will be debrided using hand and ultrasonic devices and then ADDG particles will fill the defect. Vertical or horizontal mattress sutures and additional interrupted single sutures will be performed to obtain primary closure of the interdental space. The selection of the suturing technique will be based upon the dimension of the interdental space and the thickness and height of the interdental tissues using 5-0 proline suture then follow up period at 3 months and 6 months measuring CAL which is primary outcome and radiographic bone fill , probing depth and recession which are secondary outcome.

Study Overview

• Status: Recruiting
• Conditions: Intrabony Defect
• Intervention / Treatment: Procedure: autogenous demineralized dentin graft as bone substitute in treatment of intrabony defect

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: omnia alfekky, bachelor; Phone Number: +20 1019604560; Email: omnia.abdlmonaem@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Cairo University
    • Contact: omnia alfekky, bachelor; Email: omnia.abdlmonaem@dentistry.cu.edu.eg
    • Contact: weam Elbattawy, doctor; Email: weam.elbattawy@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient-related criteria:

Motivated patient 18 years of age or order.

• Patient consulting in the outpatient clinic.
• Patient ready to perform oral hygiene instructions.
• Provide informed consent.
• Accepts the 6 months follow-up period.

Teeth related criteria:

• Tooth with one or two walled intra-bony defect, probing depth ≥ 5mm with intra osseous defect ≥ 3mm.
• Mature permanent tooth.
• Unrestorable tooth or fractured tooth beyond restoration, impacted third molar or Supernumerary tooth to be extracted and used as whole tooth graft inside the defect

Exclusion Criteria:

• Patient-related criteria:

  • Medically compromised patients.
  • Pregnant women.
  • Uncooperative patients.
  • Smokers.
  • Systemic diseases that may compromise healing or bone metabolism (e.g diabetes, hyperthyroidism)

Teeth related criteria:

• Teeth with supra-bony defects.
• Teeth with grade III mobility.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: autogenous demineralized dentin graft as bone substitute in treatment of intrabony defect	Procedure: autogenous demineralized dentin graft as bone substitute in treatment of intrabony defect; after extraction of tooth it will be grinded using hand bone mill and demineralized and placed in intrabony defect

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical attachment level gain	measured by william's periodontal probe	change from baseline at 3 month and change from baseline at 6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing depth	measured by William's periodontal probe	change from baseline at 3 month and at 6 month
Radiographic bone fill	periapical radiograph using Digora system	change from baseline at 3 month and at 6 month
Recession	measured by William's periodontal probe	change from baseline at 3 month and at 6 month

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: weam Elbattway, doctor, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2022
• Primary Completion (Anticipated): May 22, 2023
• Study Completion (Anticipated): September 22, 2023

Study Registration Dates

• First Submitted: June 28, 2022
• First Submitted That Met QC Criteria: June 30, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: June 30, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 11422

Drug and device information, study documents

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