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

NCT05445102 | Unknown Phase 3 DMC

• 1 other identifier: 11422
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intrabony Defect

Outcome Measures

Primary Outcomes (1)

• Clinical attachment level gain

  measured by william's periodontal probe

  change from baseline at 3 month and change from baseline at 6 month

Secondary Outcomes (3)

• Probing depth

  change from baseline at 3 month and at 6 month

• Radiographic bone fill

  change from baseline at 3 month and at 6 month

• Recession

  change from baseline at 3 month and at 6 month

Study Arms (1)

autogenous demineralized dentin graft as bone substitute in treatment of intrabony defect

EXPERIMENTAL

Procedure: autogenous demineralized dentin graft as bone substitute in treatment of intrabony defect

Interventions

autogenous demineralized dentin graft as bone substitute in treatment of intrabony defect PROCEDURE

after extraction of tooth it will be grinded using hand bone mill and demineralized and placed in intrabony defect

autogenous demineralized dentin graft as bone substitute in treatment of intrabony defect

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Bone Substitutes

Intervention Hierarchy (Ancestors)

Biocompatible Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• weam Elbattway, doctor

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

omnia alfekky, bachelor

CONTACT

1019604560; omnia.abdlmonaem@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 6, 2022
• Study Start: May 22, 2022
• Primary Completion: May 22, 2023
• Study Completion: September 22, 2023
• Last Updated: July 6, 2022

Record last verified: 2022-06

Locations

EG (1)