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Completed

NCT Number: NCT05231330

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.

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Key information

Conditions

Caries,Dental Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suez canal university

Suez, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

silvernanoparticles

Drug

silvernanoparticles in fluoride varnish

SDF

Drug

silver diamine fluoride

Other names: silver diamine fluoride

Primary outcomes

  1. Cold pulp testing

    Time frame: 6 months

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

  2. Absence of spontaneous pain

    Time frame: 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

    Time frame: 6 month

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

  4. sensitivity to percussion

    Time frame: 6 month

    recorded as yes or no

  5. visual inspection for sinus/ fistula swelling

    Time frame: 6 month

    recorded as yes or no

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Feb 9, 2022
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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