Clinical trial NCT05445102: Effect of Autogenous Demineralized Dentin as a Bone Graft Substitute in Management of Periodontal Intrabony Defects
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Intrabony Defect
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical attachment level gain
timeFrame: change from baseline at 3 month and change from baseline at 6 month
Secondary outcomes:
measure: Probing depth
timeFrame: change from baseline at 3 month and at 6 month
measure: Radiographic bone fill
timeFrame: change from baseline at 3 month and at 6 month
measure: Recession
timeFrame: change from baseline at 3 month and at 6 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: weam Elbattway, doctor
role: STUDY_DIRECTOR
References: