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Clinical and Radiographic Evaluation of Nano Silver Fluoride Versus Calcium Hydroxide in Indirect Pulp Treatment

NCT ID: NCT04005872

Last Updated: 2022-12-20

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2022-11-30

Brief Summary

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The management of deep carious lesions approaching a healthy pulp is considered a challenge to the dental practitioner. The conventional treatment of deep carious lesions requires the removal of all infected and affected dentin to avoid more cariogenic activity.

Detailed Description

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This study is designed to assess the clinical and radiographic effectivness of nano silver fluoride versus calcium hydroxide in an indirect pulp treatment of deep carious second primary molars. This clinical study is important because World Health Organization (WHO) has reported that school children experience to dental caries was 60-90% of worldwide (P. D. Garkoti et al., 2015).

This clinical trial has potential benefits to patients where indirect pulp treatment preserves pulp vitality by partial caries removal without exposing pulp. Several materials have been used for indirect pulp technique including calcium hydroxide (Metalita M et al., 2016).

Conditions

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Deep Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This clinical trial has potential benefits to patients where indirect pulp treatment preserves pulp vitality by partial caries removal without exposing pulp. Several materials have been used for indirect pulp technique including calcium hydroxide
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Eligible consented participants will be randomly assigned to know which side of the participant (right or left) will be control or intervention group according to a sequence generated on a Microsoft Excel sheet where the intervention (I) and the control (C) are simply randomized.

Study Groups

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Nano Silver Fluoride

2 drops of nano silver fluoride (NSF) applied on the last soft carious layer using micro brush

Group Type EXPERIMENTAL

Nano Silver Fluoride

Intervention Type DRUG

Nano silver fluoride (NSF) is a new material consisting of nano silver particles, chitosan and sodium fluoride. It is a bacteriostatic and bactericidal compound.

Calcium Hydroxide

Calcium hydroxide placed on the last soft carious layer approaching the pulp

Group Type ACTIVE_COMPARATOR

Calcium hydroxide

Intervention Type DRUG

Calcium hydroxide is a gold standard for indirect pulp capping which induces hard tissue.

Interventions

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Nano Silver Fluoride

Nano silver fluoride (NSF) is a new material consisting of nano silver particles, chitosan and sodium fluoride. It is a bacteriostatic and bactericidal compound.

Intervention Type DRUG

Calcium hydroxide

Calcium hydroxide is a gold standard for indirect pulp capping which induces hard tissue.

Intervention Type DRUG

Other Intervention Names

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NSF CaoH

Eligibility Criteria

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Inclusion Criteria

Patients:

* Cooperative children.
* Both genders.
* In age range from 4 to 7 years.

Teeth:

* Vital second primary molars with deep caries limited to occlusal surface.
* No clinical signs or symptoms of irreversible pulpitis or pulp necrosis.
* No radiographic abnormalities
* Restorable teeth.

Exclusion Criteria

* • Children with known history of allergy to any of the tested materials.

* Children with systemic conditions.
* Parents who refused to participate.
Minimum Eligible Age

4 Years

Maximum Eligible Age

7 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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Heba Moahmed Fouad

Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Heba Mohamed Refaat Fouad Genena

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Cairo U E

Identifier Type: -

Identifier Source: org_study_id