Randomized Clinical and Radiographic Study

NCT ID: NCT06609720

Last Updated: 2024-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-12-30

Brief Summary

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Randomized clinical and radiographic trial

Detailed Description

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

Conditions

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Autogenous Dentin Graft

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 groups with 2 subgroups, each subgroup receive either ADG or DFDBA
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group 1 subgroup A

Grade II furcation involvement treated with autogenous dentin graft

Group Type EXPERIMENTAL

(guided tissue regeneration)

Intervention Type PROCEDURE

Randomized clinical and radiographic trial

Group 1 Subgroup B

Grade II furcation involvement treated with demineralized freeze-dried bone allograft

Group Type EXPERIMENTAL

(guided tissue regeneration)

Intervention Type PROCEDURE

Randomized clinical and radiographic trial

Group II subgroup A

Grade III furcation involvement treated with Autogenous dentin graft

Group Type EXPERIMENTAL

(guided tissue regeneration)

Intervention Type PROCEDURE

Randomized clinical and radiographic trial

Group II subgroup B

Grade III furcation involvement treated with demineralized freeze-dried bone allograft

Group Type EXPERIMENTAL

(guided tissue regeneration)

Intervention Type PROCEDURE

Randomized clinical and radiographic trial

Interventions

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(guided tissue regeneration)

Randomized clinical and radiographic trial

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Banan Lotfy Mohamed Amer

Assistant lecturer at periodontology department, Principal Investigator, MSC

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Banan L Amer, Master

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Samia A Darwish, Professor

Role: STUDY_DIRECTOR

Tanta University

Locations

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Faculty of dentistry

Tanta, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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OMPDR

Identifier Type: -

Identifier Source: org_study_id

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