Evaluation of Autogenous Demineralized Dentin Graft Vs Autogenous Bone Graft in Management of Intrabony Defects

Recruiting now · Phase 4

Conditions studied: Intrabony Periodontal Defect

In brief

The main goal is to evaluate and compare the clinical and radiographic efficacy of autogenous demineralized dentin as bone graft substitute versus autogenous bone graft when performed with modified minimally invasive surgical technique (M-MIST) in the treatment of periodontal intrabony defects. The main question is: In periodontitis patients with intrabony defects, will using autogenous demineralized dentin as bone graft substitute result in clinical attachment gain and linear bone fill similar to autogenous bone graft following modified minimally invasive surgical technique? After enrolment, each participant with intra-bony defects will receive the initial phase of the therapy, which will include oral hygiene instructions, supragingival and subgingival debridement using ultrasonic and hand instrumentations and relieving of occlusal trauma if any. After 4-6 weeks, an individually customized positioning stent will be fabricated for each participant and a pre-operative periapical x-ray using parallel-angle technique will be employed using X-ray film holding system to ensure accuracy and reproducibility of the measurements. Criteria used to indicate that surgery is required include the persistence of interproximal defect with PD (Probing depth) ≥ 5 mm, CAL (Clinical attachment loss) ≥ 4 mm. Surgical procedures will include flap elevation for approaching the defect-associated sites using the modified minimally invasive surgical technique (M-MIST). Intervention group: The defect will be filled with autogenous demineralized dentin graft prepared from the participant's freshly extracted own teeth. Control group: The defect will be filled with autogenous bone graft harvested from the retromolar area. For both groups, flaps will be approximated and sutured at the original position. All the subjects will be evaluated at 1, 3, and 6 months for clinical and radiographic parameters. Outcomes:The results of Clinical attachment level (CAL) gain, Linear bone fill, Gingival index (GI), Plaque index (PI), Probing pocket depth (PPD), Gingival recession (GR), Bleeding on probing (BoP), Postoperative pain and Patient satisfaction will be measured at baseline, 1 month, 3 months and after 6 months.

Key facts

Study ID: NCT06048042
Run by: Cairo University
People needed: 24
Starts: 2024-07-17
Expected to finish: 2025-03-01
Last updated by the study team: 2024-08-26

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

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 two or three-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 intrabony 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).
Failure to maintain good oral hygiene.
Teeth related criteria:
Teeth with supra-bony defects.
Teeth with grade III mobility.
Teeth having interproximal craters, grade III furcation involvement, and grade III mobility.
Presence of caries or overhanging restorations.
Presence of peri-apical injuries.

Where it is running

Faculty of Dentistry, Cairo University — Cairo, Egypt (enrolling)

Full record on ClinicalTrials.gov

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