Evaluation of Nano-crystalline Hydroxyapatite Silica Gel in Management of Periodontal Intrabony Defects

NCT ID: NCT02507596

Last Updated: 2022-03-11

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2019-12-31

Brief Summary

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A clinical and radiographic evaluation of Nano-crystalline hydroxyapatite silica gel in comparison with open flap debridement for management of periodontal intrabony defects.

Detailed Description

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Thirty patients suffering from advanced chronic periodontitis were included in this randomized controlled clinical trial. Each subject contributed matched two- or three-walled intrabony defects. Patients were equally assigned into the experimental group; Nano-crystalline hydroxyapatite silica gel or the negative control group;open flap debridement. Clinical and radiographic parameters were recorded at baseline and at 3 and 6 months postoperatively.

Conditions

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Chronic Periodontitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Nano-crystalline hydroxyapatite silica gel

hydroxyapaptite bone graft with nano particle size in silica gel will be used to fill in the defect after opening a periodontal flap

Group Type EXPERIMENTAL

Nano-crystalline hydroxyapatite silica gel

Intervention Type BIOLOGICAL

it is a type of synthetic bone graft.

Open flap debridement

an open periodontal flap without adding bone graft.

Group Type SHAM_COMPARATOR

open flap debridement

Intervention Type PROCEDURE

a periodontal surgical procedure for the purpose of debridement.

Interventions

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Nano-crystalline hydroxyapatite silica gel

it is a type of synthetic bone graft.

Intervention Type BIOLOGICAL

open flap debridement

a periodontal surgical procedure for the purpose of debridement.

Intervention Type PROCEDURE

Other Intervention Names

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Nanobone OFD

Eligibility Criteria

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Inclusion Criteria

* Severe chronic periodontitis patients.
* having at least one site with pocket depth ≥ 6 mm and clinical attachment level ≥ 5 mm, with radiographic evidence of bone loss as detected in periapical radiographs.

Exclusion Criteria

* Pregnant women
* Subjects had \<22 permanent teeth
* Having any given systemic disease
* Taking any type of medication and/or antibiotic therapy during the 3 months before the study
* Received periodontal treatment within the past 12 months Current or former smokers
Minimum Eligible Age

35 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Noha Ayman Ghallab

Associate Professor of Oral Medicine and Periodontology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Weam Battawy, MD

Role: STUDY_CHAIR

Lecturer of Oral Medicine and Periodontology

Noha Ghallab, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Oral Medicine and Periodontology

Dalia AbdelHamid, MD

Role: STUDY_DIRECTOR

Associate Professor of Biomaterials

Riham Hamdy, MD

Role: STUDY_CHAIR

Associate Professor of Oral and Maxillofacial Radiology

Locations

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Faculty of Oral and Dental Medicine, Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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Reynolds MA, Aichelmann-Reidy ME, Branch-Mays GL, Gunsolley JC. The efficacy of bone replacement grafts in the treatment of periodontal osseous defects. A systematic review. Ann Periodontol. 2003 Dec;8(1):227-65. doi: 10.1902/annals.2003.8.1.227.

Reference Type BACKGROUND
PMID: 14971256 (View on PubMed)

Heinz B, Kasaj A, Teich M, Jepsen S. Clinical effects of nanocrystalline hydroxyapatite paste in the treatment of intrabony periodontal defects: a randomized controlled clinical study. Clin Oral Investig. 2010 Oct;14(5):525-31. doi: 10.1007/s00784-009-0325-x. Epub 2009 Aug 13.

Reference Type BACKGROUND
PMID: 19680697 (View on PubMed)

Kasaj A, Rohrig B, Zafiropoulos GG, Willershausen B. Clinical evaluation of nanocrystalline hydroxyapatite paste in the treatment of human periodontal bony defects--a randomized controlled clinical trial: 6-month results. J Periodontol. 2008 Mar;79(3):394-400. doi: 10.1902/jop.2008.070378.

Reference Type BACKGROUND
PMID: 18315420 (View on PubMed)

Other Identifiers

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Nanobone_IBD

Identifier Type: -

Identifier Source: org_study_id

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