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

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.

Study Overview

• Status: Completed
• Conditions: Caries,Dental
• Intervention / Treatment: Drug: silvernanoparticles; Drug: SDF

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Suez, Egypt
    • Suez Canal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: silver nanoparticles	Drug: silvernanoparticles; silvernanoparticles in fluoride varnish
ACTIVE_COMPARATOR: silverdiamine fluoride	Drug: SDF; silver diamine fluoride; Other Names: silver diamine fluoride
NO_INTERVENTION: no medicament

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Suez Canal University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2020
• Primary Completion (ACTUAL): October 1, 2020
• Study Completion (ACTUAL): March 1, 2021

Study Registration Dates

• First Submitted: December 23, 2021
• First Submitted That Met QC Criteria: January 28, 2022
• First Posted (ACTUAL): February 9, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 9, 2022
• Last Update Submitted That Met QC Criteria: January 28, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: HR1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No