Clinical and Radiographic Evaluation of Autogenous Demineralized Dentin Graft Versus Autogenous Bone Graft in Management of Periodontal Intrabony Defects Using Modified Minimally Invasive Surgical Technique: A Non-Randomized Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
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• 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.

Locations
Other Locations
Egypt
Faculty of Dentistry, Cairo University
RECRUITING
Cairo
Contact Information
Primary
Ghada M. Abouhussein, Bachelor
ghada.mohammed@dentistry.cu.edu.eg
+02 01004966156
Backup
Nesma Shemais, Ass Lecturer
nesma.shemais@dentistry.cu.edu.eg
Time Frame
Start Date: 2024-07-17
Estimated Completion Date: 2025-03
Participants
Target number of participants: 24
Treatments
Experimental: Autogenous Demineralized Dentin Graft
An Autogenous Demineralized Dentin Graft will be prepared from the participant's freshly extracted teeth and placed in the intrabony defect following the modified minimally invasive surgical technique.
Active_comparator: Autogenous bone Graft
An Autogenous Bone Graft will be harvested from the retromolar area and placed in the intrabony defect following the modified minimally invasive surgical technique.
Related Therapeutic Areas
Sponsors
Leads: Cairo University

This content was sourced from clinicaltrials.gov