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

Caries,Dental Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05231330
• Other study ID #: HR1
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Caries,Dental
• Dental Caries

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