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

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05445102

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intrabony Defect	Procedure: autogenous demineralized dentin graft as bone substitute in treatment of intrabony defect	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 22, 2022

Anticipated Primary Completion Date :

May 22, 2023

Anticipated Study Completion Date :

Sep 22, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Clinical attachment level gain [change from baseline at 3 month and change from baseline at 6 month]
measured by william's periodontal probe

Secondary Outcome Measures

Probing depth [change from baseline at 3 month and at 6 month]
measured by William's periodontal probe
Radiographic bone fill [change from baseline at 3 month and at 6 month]
periapical radiograph using Digora system
Recession [change from baseline at 3 month and at 6 month]
measured by William's periodontal probe

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo University	Cairo		Egypt

Sponsors and Collaborators

Cairo University

Investigators

Study Director: weam Elbattway, doctor, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Omnia Mohamed Shehata Abde Elmonaem, principal investigator, Cairo University

ClinicalTrials.gov Identifier:

NCT05445102

Other Study ID Numbers:

11422

First Posted:

Jul 6, 2022

Last Update Posted:

Jul 6, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 6, 2022