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

Primary Purpose

Caries,Dental

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
silvernanoparticles
SDF
Sponsored by
Suez Canal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caries,Dental

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Suez canal university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

silver nanoparticles

silverdiamine fluoride

no medicament

Arm Description

Outcomes

Primary Outcome Measures

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).
Radiographic examination
Indicating presence of periapical radiolucencies, widening of lamina dura, internal and external root resorption (presence/ absence).
sensitivity to percussion
recorded as yes or no
visual inspection for sinus/ fistula swelling
recorded as yes or no

Secondary Outcome Measures

Full Information

First Posted
December 23, 2021
Last Updated
January 28, 2022
Sponsor
Suez Canal University
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1. Study Identification

Unique Protocol Identification Number
NCT05231330
Brief Title
Clinical Evaluation of Silver Nanoparticles in Comparison to Silver Diamine Fluoride in Management of Deep Carious Lesions
Official Title
Clinical Evaluation of Silver Nanoparticles in Comparison to Silver Diamine Fluoride in Management of Deep Carious Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Suez Canal University

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries,Dental

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
silver nanoparticles
Arm Type
Experimental
Arm Title
silverdiamine fluoride
Arm Type
Active Comparator
Arm Title
no medicament
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
silvernanoparticles
Intervention Description
silvernanoparticles in fluoride varnish
Intervention Type
Drug
Intervention Name(s)
SDF
Other Intervention Name(s)
silver diamine fluoride
Intervention Description
silver diamine fluoride
Primary Outcome Measure Information:
Title
Cold pulp testing
Description
: An ice-rod will be used for this test. Results should be positive or negative.
Time Frame
6 months
Title
Absence of spontaneous pain
Description
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).
Time Frame
6 month
Title
Radiographic examination
Description
Indicating presence of periapical radiolucencies, widening of lamina dura, internal and external root resorption (presence/ absence).
Time Frame
6 month
Title
sensitivity to percussion
Description
recorded as yes or no
Time Frame
6 month
Title
visual inspection for sinus/ fistula swelling
Description
recorded as yes or no
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Suez canal university
City
Suez
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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