Randomized Clinical and Radiographic Study

Not Applicable

Completed

• Conditions: Autogenous Dentin Graft
• Interventions: Procedure: (guided tissue regeneration)

• Registration Number: NCT06609720
• Lead Sponsor: Tanta University

Brief Summary

Randomized clinical and radiographic trial

Detailed Description

Evaluation of Autogenous Dentin Graft versus Demineralized Freeze-Dried Bone Allograft in the Treatment of Class ΙΙ and ΙΙΙ Mandibular Furcation Defects

Study Timeline

• Status Verified: 2021-02
• Study Start: 2021-03-01
• Study First Submitted: 2023-12-05
• Primary Completion: 2023-12-12
• Study Completion: 2023-12-30
• Study First Submitted QC: 2024-09-23
• Last Update Submitted: 2024-09-23
• Study First Posted: 2024-09-24
• Last Update Posted: 2024-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Presence of class II and/or ΙΙΙ furcation defects in mandibular first or second molars according to criteria outlined by Hamp et. al. 1975.

• Horizontal probing depth ≥3 mm using Naber's probe.
• Clinical attachment level ≥3 mm measured from cemento-enamel junction (CEJ) till the deepest probing depth.
• Evidence of radiolucency in the furcation area on panoramic radiograph.
• Patients who will be assigned for groups (I and II) should present with teeth required for extraction due to advanced periodontal bone loss or other indications such as hopeless wisdom teeth or orthodontic indications or unrestorable fractured teeth as a source for autogenous dentin graft (ADG).

Exclusion Criteria

• Medically compromised patients and systemic conditions precluding periodontal surgery.

  • Mandibular first or second molars with root caries or endodontic treatment.
  • Smokers, diabetics, pregnant or lactating women.
  • History of chemotherapy, radiotherapy in head and/or neck region.
  • Bisphosphonate therapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 subgroup A	(guided tissue regeneration)	Grade II furcation involvement treated with autogenous dentin graft
Group 1 Subgroup B	(guided tissue regeneration)	Grade II furcation involvement treated with demineralized freeze-dried bone allograft
Group II subgroup A	(guided tissue regeneration)	Grade III furcation involvement treated with Autogenous dentin graft
Group II subgroup B	(guided tissue regeneration)	Grade III furcation involvement treated with demineralized freeze-dried bone allograft

Primary Outcome Measures

Name	Time	Method
Probing pocket depth	Measured at baseline, 6 months and 12 months	According to Ramfjord, clinical parameter measured by UNC periodontal probe from a fixed point to the deepest probing depth. Using stent to standardize the measurements.
Clinical attachment level	Measured at baseline, 6 months and 12 months	According to Ramfjord, clinical parameter measured by a Naber\'s probe. Using stent to standard measurements.
Bleeding on probing	Measured at baseline, 6 months and 12 months	According to Ramfjord, the bleeding at each site observed after probing and recorded positive if bleeding was observed within 30 seconds, if not was recorded as negative.

Secondary Outcome Measures

Name	Time	Method
Radiographic outcome	measured at baseline and 1 year follow up	Using CBCT software to analyse furcation volume

Trial Locations

Locations (1)

Faculty of dentistry; 🇪🇬 Tanta, Egypt