NCT05445102

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

Status unknown Phase 3 Last updated 6 July 2022

What this trial tests

Phase 3 trial testing autogenous demineralized dentin graft as bone substitute in treatment of intrabony defect in Intrabony Defect in 10 participants. Status unknown.

Timeline

22 May 2022

Primary endpoint
22 May 2023

22 September 2023

Quick facts

Lead sponsor	Cairo University
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	22 May 2022
Primary completion	22 May 2023
Estimated completion	22 September 2023
Sites	1 location across Egypt

Drugs / interventions tested

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

Conditions studied

• Intrabony Defect — all drugs for Intrabony Defect →

Sponsor

Cairo University

Who can join

Adults 18 to 60, any sex, with Intrabony Defect. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.