Randomized Clinical and Radiographic Study

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

Randomized clinical and radiographic trial

Study Overview

• Status: Completed
• Conditions: Autogenous Dentin Graft
• Intervention / Treatment: Procedure: (guided tissue regeneration)

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 subgroup A; Grade II furcation involvement treated with autogenous dentin graft	Procedure: (guided tissue regeneration); Randomized clinical and radiographic trial
Experimental: Group 1 Subgroup B; Grade II furcation involvement treated with demineralized freeze-dried bone allograft	Procedure: (guided tissue regeneration); Randomized clinical and radiographic trial
Experimental: Group II subgroup A; Grade III furcation involvement treated with Autogenous dentin graft	Procedure: (guided tissue regeneration); Randomized clinical and radiographic trial
Experimental: Group II subgroup B; Grade III furcation involvement treated with demineralized freeze-dried bone allograft	Procedure: (guided tissue regeneration); Randomized clinical and radiographic trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing pocket depth	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.	Measured at baseline, 6 months and 12 months
Clinical attachment level	According to Ramfjord, clinical parameter measured by a Naber's probe. Using stent to standard measurements.	Measured at baseline, 6 months and 12 months
Bleeding on probing	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.	Measured at baseline, 6 months and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic outcome	Using CBCT software to analyse furcation volume	measured at baseline and 1 year follow up

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Banan L Amer, Master, Tanta University; Study Director: Samia A Darwish, Professor, Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): December 12, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: December 5, 2023
• First Submitted That Met QC Criteria: September 23, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Actual): September 24, 2024
• Last Update Submitted That Met QC Criteria: September 23, 2024
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: dentin graft, tooth graft
• Other Study ID Numbers: OMPDR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes