Clinical Evaluation of Silver Nanoparticles in Comparison to Silver Diamine Fluoride in Management of Deep Carious Lesions

NCT ID: NCT05231330

Last Updated: 2022-02-09

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-03-01

Brief Summary

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this clinical study will be carried out to evaluate the effect of fluoride varnish with silver nanoparticles in comparison to silver diamine fluoride in management of deep carious lesions.

Detailed Description

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Conditions

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Caries,Dental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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silver nanoparticles

Group Type EXPERIMENTAL

silvernanoparticles

Intervention Type DRUG

silvernanoparticles in fluoride varnish

silverdiamine fluoride

Group Type ACTIVE_COMPARATOR

SDF

Intervention Type DRUG

silver diamine fluoride

no medicament

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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silvernanoparticles

silvernanoparticles in fluoride varnish

Intervention Type DRUG

SDF

silver diamine fluoride

Intervention Type DRUG

Other Intervention Names

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silver diamine fluoride

Eligibility Criteria

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Inclusion Criteria

* success will be evaluated by:

1. Cold pulp testing: An ice-rod will be used for this test. Results should be positive or negative.
2. Absence of spontaneous pain: Post-operative pain will be assessed using the visual Analogue Scale Score (VAS), which is a measurement method for subjective characteristics of pain. Respondents specify their level of agreement to a statement by indicating a position along a 10 cm line between two end-points, with the term "no sensitivity" at one end and "intolerable sensitivity" at the other end. A score from (0 to 10 is given).
3. Sensitivity to percussion: (presence/ absence).
4. Inspection for Sinus/fistula/swelling: using visual inspection (presence/ absence).
5. Radiographic examination: Indicating presence of periapical radiolucencies, widening of lamina dura, internal and external root resorption (presence/ absence).

Exclusion Criteria

* Patient-related criteria:

* Medically compromised patients, who will not be able to attend multiple appointments or may require special management.
* Pregnant women; as radiographs cannot be taken for them.
* Allergy to any of the restorative materials, including anesthetics.
* Uncooperative patients, will not abide by the instructions or attend the appointments.

Tooth related criteria:

* Retained deciduous teeth; as the study is targeting only permanent teeth.
* Teeth with previous restorations, which may add another variable to the study (type of old restorative material, extent of recurrent caries.
* Teeth with cervical caries; which can't be evaluated on periapical radiographs
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Suez Canal University

OTHER

Sponsor Role lead

Responsible Party

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Kareem Hamdy Ahmed Aly

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Suez canal university

Suez, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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HR1

Identifier Type: -

Identifier Source: org_study_id

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