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

NCT06048042 | Recruiting Phase 4

• 1 other identifier: ghadashatra123
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intrabony Periodontal Defect

Keywords

Intrabony Periodontal Defect; Demineralized dentin graft; Autogenous bone graft; modified minimally invasive surgical technique; M-MIST

Outcome Measures

Primary Outcomes (1)

• Clinical attachment level (CAL) gain change from baseline to 6 months.

  The CAL will be clinically measured using UNC 15 periodontal probe from the cemento-enamel junction (CEJ) to the depth of defect. An individually customized positioning stent will be fabricated for each patient to ensure accuracy and reproducibility of the measurements.

  CAL gain will be taken at baseline, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner.

Secondary Outcomes (8)

• Linear bone fill change from baseline to 6 months

  Linear bone fill will be measured at baseline, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner

• Gingival index (GI) change from baseline to 6 months

  GI will be measured baseline, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner

• Plaque index (PI) change from baseline to 6 months

  PI will be measured baseline, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner

• Probing pocket depth (PPD) change from baseline to 6 months

  PPD will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.

• Gingival recession (GR) change from baseline to 6 months

  GR will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.

Study Arms (2)

Autogenous Demineralized Dentin Graft

EXPERIMENTAL

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.

Biological: Autogenous Demineralized Dentin Graft

Autogenous bone Graft

ACTIVE COMPARATOR

An Autogenous Bone Graft will be harvested from the retromolar area and placed in the intrabony defect following the modified minimally invasive surgical technique.

Biological: Autogenous Bone Graft

Interventions

Autogenous Demineralized Dentin Graft BIOLOGICAL

The participant's own freshly extracted tooth will be cleaned from periodontal ligaments, cementum, soft tissue attachment, caries, or restorations (if present) and have their crown decapitated, using a high- speed fine finishing stone and saline irrigation. The pulp chamber and root pulp will be cleaned by split opening the root and cleaning it out using a high-speed diamond bur. Subsequently, teeth will be ground, and demineralized using a hand bone mill. Then the particles will be prepared by demineralization of tooth particles in 0.6N hydrochloric acid5 for 30 min then washed twice in saline and dried with sterile gauze. Then it will be used as a graft for the intra-bony defect after modified minimally invasive surgical technique.

Autogenous Demineralized Dentin Graft

Autogenous Bone Graft BIOLOGICAL

Modified minimally invasive surgical technique (M-MIST) will be performed in the intra-bony defects, with autogenous bone graft placement. The graft will be harvested from the retromolar area using automatic chip maker (ACM) bur and a hand bone mill will be used to grind the chips into particles, then it will be placed in the defect.

Autogenous bone Graft

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

RECRUITING

Study Officials

• Ghada M. Abouhussein, Bachelor

  Cairo University

  PRINCIPAL INVESTIGATOR

• Weam El-Battawy, Ass professor

  Cairo University

  STUDY DIRECTOR

• Nesma Shemais, Ass lecturer

  Cairo University

  STUDY CHAIR

Central Study Contacts

Ghada M. Abouhussein, Bachelor

CONTACT

+02 01004966156; ghada.mohammed@dentistry.cu.edu.eg

Nesma Shemais, Ass Lecturer

CONTACT

nesma.shemais@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master Degree student, Periodontology department, Faculty of Dentistry, Cairo University

Model Details: A non-randomized Clinical Trial

Study Record Dates

• First Submitted: September 9, 2023
• First Posted: September 21, 2023
• Study Start: July 17, 2024
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: August 26, 2024

Record last verified: 2024-08

Locations

EG (1)