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

Not Applicable

Completed

• Conditions: Caries,Dental
• Interventions: Drug: silvernanoparticles; Drug: SDF

• Registration Number: NCT05231330
• Lead Sponsor: Suez Canal University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Primary Completion: 2020-10-01
• Study Completion: 2021-03-01
• Study First Submitted: 2021-12-23
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-28
• Last Update Submitted: 2022-01-28
• Study First Posted: 2022-02-09
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
silver nanoparticles	silvernanoparticles	-
silverdiamine fluoride	SDF	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Suez canal university; 🇪🇬 Suez, Egypt