Clinical Trial

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

Recruiting Phase 4
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Record status
This record was last updated August 26, 2024 (before its estimated January 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-09-19; most recent amendment 2024-08-23.
Status change: Not Yet Recruiting → Recruiting 2024-03-11
Trial Details
NCT Number NCT06048042
Lead Sponsor Cairo University
Conditions Intrabony Periodontal Defect
Enrollment 24 participants
Start Date 2024-07-17
Primary Completion 2025-01 (estimated)
Study Completion 2025-03 (estimated)
Updated on ClinicalTrials.gov 2024-08-26