Evaluation of Injectable Beta-tricalcium Phosphate Clinically in Treatment of Grade II Furcation Involvement

NCT ID: NCT04443972

Last Updated: 2020-06-23

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

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-12

Study Completion Date

2020-02-04

Brief Summary

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This study will be conducted to evaluate clinically and radiographically the use of PD VitalOs cement® bone graft in the treatment of class II furcation defects comparing with Hydroxyapatite bone graft and biodegradable collagen membrane in the treatment of class II furcation defects.

Detailed Description

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The study is a randomized, controlled clinical trial. Patients were randomly divided into two equal groups, Group I (Test group): included seven Grade II furcation defects treated by beta tricalcium phosphate bone cement only.

Group II (Control group): included seven Grade II furcation defects treated with granulated beta tricalcium phosphate bone graft covered by resorbable collagen membrane.

Conditions

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Furcation Defects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PD VitalOs cement® alone

class II furcation defects that will be treated with PD VitalOs cement® alone

Group Type EXPERIMENTAL

PD VitalOs cement®

Intervention Type OTHER

PD VitalOs cement®\* is a synthetic bone grafting cement designed for bone void filling and bone regeneration in dental surgery

PD VitalOs cement® plus Bone graft and membrane

PD VitalOs cement® and Hydroxyapatite bone graft and biodegradable collagen membrane in the treatment of class II furcation defects.

Group Type EXPERIMENTAL

PD VitalOs cement®

Intervention Type OTHER

PD VitalOs cement®\* is a synthetic bone grafting cement designed for bone void filling and bone regeneration in dental surgery

Hydroxyapatite bone graft

Intervention Type OTHER

a bioceramic bone substitute, providing a scaffold for bone deposition

biodegardable collagen membrane

Intervention Type OTHER

provide efficacious barriers that were interposed between the flap and root surface.

Interventions

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PD VitalOs cement®

PD VitalOs cement®\* is a synthetic bone grafting cement designed for bone void filling and bone regeneration in dental surgery

Intervention Type OTHER

Hydroxyapatite bone graft

a bioceramic bone substitute, providing a scaffold for bone deposition

Intervention Type OTHER

biodegardable collagen membrane

provide efficacious barriers that were interposed between the flap and root surface.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* • Presence of a lower molar with critical size grade II furcation defect (15) with a horizontal component of 4 mm and a vertical component of 4 to 6 mm (18), detected using Naber's probe and William's periodontal probe.

* Patient's age between 30 - 50 years.
* Both sexes.
* The patient should be psychologically accepting the procedures.
* Patients should be systemically free.

Exclusion Criteria

* • Uncooperative patients regarding oral hygiene measures performance.

* Patients with para functional habits.
* Smokers.
* Pregnant or lactating women.
* Patients who underwent any periodontal surgeries in the study site during the six months prior to study.
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alexandria University

OTHER

Sponsor Role collaborator

Hams Hamed Abdelrahman

OTHER

Sponsor Role lead

Responsible Party

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Hams Hamed Abdelrahman

Assistant lecturer

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ahmed Hosny Elsayed, BDS

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

shahira Ali El Damaty, PHD

Role: STUDY_DIRECTOR

Alexandria University

Gehan Sherif Kotry, PHD

Role: STUDY_DIRECTOR

Alexandria University

Rania Abd El Aziz Fahmy, PHD

Role: STUDY_DIRECTOR

Alexandria University

Locations

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outpatient clinic of oral medicine department, faculty of dentistry, Alexandria university

Alexandria, , Egypt

Site Status

Countries

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Egypt

References

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Other Identifiers

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Furcation invlvement

Identifier Type: -

Identifier Source: org_study_id

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