Caries,Dental
Conditions
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.
Interventions
DRUGsilvernanoparticles
silvernanoparticles in fluoride varnish
DRUGSDF
silver diamine fluoride
Sponsors
Suez Canal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Outcome results
None listed