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

Study Overview
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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.

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

Conditions
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Caries,Dental

Intervention / Treatment
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* Drug: silvernanoparticles
* Drug: SDF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: success will be evaluated by: Cold pulp testing: An ice-rod will be used for this test. Results should be positive or negative. 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). Sensitivity to percussion: (presence/ absence). Inspection for Sinus/fistula/swelling: using visual inspection (presence/ absence). 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: silver nanoparticles<br> | Drug: silvernanoparticles<br>* silvernanoparticles in fluoride varnish<br>|
| Active Comparator: silverdiamine fluoride<br> | Drug: SDF<br>* silver diamine fluoride<br>* Other names: silver diamine fluoride;|
| No Intervention: no medicament<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cold pulp testing | : An ice-rod will be used for this test. Results should be positive or negative. | 6 months | 
| 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). | 6 month | 
| Radiographic examination | Indicating presence of periapical radiolucencies, widening of lamina dura, internal and external root resorption (presence/ absence). | 6 month | 
| sensitivity to percussion | recorded as yes or no | 6 month | 
| visual inspection for sinus/ fistula swelling | recorded as yes or no | 6 month |