Chitosan Nano-hydroxyapatite Hydrogel in Non-Surgical Treatment of Intrabony Defect

NCT ID: NCT06373757

Last Updated: 2024-04-18

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2023-09-01

Brief Summary

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The aim of this study was to evaluate the clinical effect of Chitosan with nano-hydroxyapatite hydrogel in the treatment of periodontal intrabony defects.

Detailed Description

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Periodontitis is a chronic inflammation of the periodontium that extends beyond the gingiva and involves the destruction of the connective tissue attachment of the teeth.

Treatment modalities of periodontitis includes local drug delivery such as chitosan which is a derivative of the exoskeleton of many arthropods including prawns, lobsters and crabs.

Chitosan has been used in guided bone regeneration, hemostasis of surgical wounds, and coating of dental implants, in reconstruction of temporomandibular joint disc and guided periodontal tissue regeneration. Moreover, chitosan has been used for preventing demineralization.

HA also called hydroxylapatite, is a naturally occurring mineral form of calcium apatite with the formula Ca5(PO4)3(OH). The OH- ion can be replaced by fluoride, and carbonate, producing fluorapatite or chlorapatite. It crystallizes in the hexagonal crystal system.

Conditions

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Chitosan Nano-hydroxyapatite Hydrogel Intrabony Defect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group I (nano-HAP/Chitosan hydrogel):

The periodontal pockets more than or equal 3-5mm were isolated. Chitosan and nano-HAP hydrogel were prepared in the same steps that were mentioned in the methodology and then the prepared gel was applied to the test site of patients with the deepest probing pocket measurement once per week for 3 weeks. Periodontal dressing (Coe-pack) was to secure the hydrogel in place.

Group Type EXPERIMENTAL

Nano-HAP/Chitosan hydrogel

Intervention Type OTHER

The periodontal pockets more than or equal 3-5mm were isolated. Chitosan and nano-HAP hydrogel were prepared in the same steps that were mentioned in the methodology and then the prepared gel was applied to the test site of patients with the deepest probing pocket measurement once per week for 3 weeks. Periodontal dressing (Coe-pack) was to secure the hydrogel in place.

Group II

Patients were treated with supra and sub-gingival debridement only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nano-HAP/Chitosan hydrogel

The periodontal pockets more than or equal 3-5mm were isolated. Chitosan and nano-HAP hydrogel were prepared in the same steps that were mentioned in the methodology and then the prepared gel was applied to the test site of patients with the deepest probing pocket measurement once per week for 3 weeks. Periodontal dressing (Coe-pack) was to secure the hydrogel in place.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age from 25 to 55 years.
* Both sexes.
* Patients with stage II to III periodontitis with probing pocket depths ≥ 5 mm and radiographic evidence showing infrabony defect.

Exclusion Criteria

* Patients received periodontal or antibiotic therapy within the previous 6 months preceding the study.
* Smokers.
* Pregnant and lactating females.
* Patients on medications known to affect bone turnover or with known side effects to chitosan, nano-hydroxyapatite, and collagen membrane.
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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October 6 University

OTHER

Sponsor Role lead

Responsible Party

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Amany Ahmed Mohamed Alaraby

Lecturer of Oral Medicine, Diagnosis and Periodontology Department, Faculty of Dentistry, October 6 University, 6 October city, Egypt

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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October 6 University

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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RECO6U/5-2023

Identifier Type: -

Identifier Source: org_study_id

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