ClinicalTrials.gg
Status unknownNCT05445102Updated Jul 6, 2022

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

A Phase 3 interventional study of autogenous demineralized dentin graft as bone substitute in treatment of intrabony defect in Intrabony Defect, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-06.

Sponsored by Cairo University · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Intrabony Defect
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • 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

Interventions

  • Procedureautogenous 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

06

What researchers measure

Primary outcomes

  1. Clinical attachment level gain

    measured by william's periodontal probe

    Time frame: change from baseline at 3 month and change from baseline at 6 month

Secondary outcomes

  1. Probing depth

    measured by William's periodontal probe

    Time frame: change from baseline at 3 month and at 6 month

  2. Radiographic bone fill

    periapical radiograph using Digora system

    Time frame: change from baseline at 3 month and at 6 month

  3. Recession

    measured by William's periodontal probe

    Time frame: change from baseline at 3 month and at 6 month

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05445102
Lead sponsor
Cairo University
Responsible party
Omnia Mohamed Shehata Abde Elmonaem (principal investigator, Cairo University) — Principal investigator
First posted
Jul 6, 2022
Start date
May 22, 2022
Primary completion
May 22, 2023 (estimated)
Completion
Sep 22, 2023 (estimated)
Last update
Jul 6, 2022

Study contacts

omnia alfekky, bachelor
Contact
omnia.abdlmonaem@dentistry.cu.edu.eg
1019604560 ext. +20
weam Elbattway, doctor
study director · Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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