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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05231330
Other study ID # HR1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2020
Est. completion date March 1, 2021

Study information

Verified date January 2022
Source Suez Canal University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date March 1, 2021
Est. primary completion date October 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
silvernanoparticles
silvernanoparticles in fluoride varnish
SDF
silver diamine fluoride

Locations

Country Name City State
Egypt Suez canal university Suez

Sponsors (1)

Lead Sponsor Collaborator
Suez Canal University

Country where clinical trial is conducted

Egypt, 

Outcome

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