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

Sponsor
Suez Canal University (Other)
Overall Status
Completed
CT.gov ID
NCT05231330
Collaborator
(none)
36
Enrollment
1
Location
3
Arms
12
Actual Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical Evaluation of Silver Nanoparticles in Comparison to Silver Diamine Fluoride in Management of Deep Carious Lesions
Actual Study Start Date :
Mar 1, 2020
Actual Primary Completion Date :
Oct 1, 2020
Actual Study Completion Date :
Mar 1, 2021

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Cold pulp testing [6 months]

      : An ice-rod will be used for this test. Results should be positive or negative.

    2. Absence of spontaneous pain [6 month]

      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. Radiographic examination [6 month]

      Indicating presence of periapical radiolucencies, widening of lamina dura, internal and external root resorption (presence/ absence).

    4. sensitivity to percussion [6 month]

      recorded as yes or no

    5. visual inspection for sinus/ fistula swelling [6 month]

      recorded as yes or no

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Suez canal university Suez Egypt

    Sponsors and Collaborators

    • Suez Canal University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kareem Hamdy Ahmed Aly, principal investigator, Suez Canal University
    ClinicalTrials.gov Identifier:
    NCT05231330
    Other Study ID Numbers:
    • HR1
    First Posted:
    Feb 9, 2022
    Last Update Posted:
    Feb 9, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Dental Caries
    Fluorides

    Study Results

    No Results Posted as of Feb 9, 2022