NCT05231330

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 9, 2022

Completed
Last Updated

February 9, 2022

Status Verified

January 1, 2022

Enrollment Period

7 months

First QC Date

December 23, 2021

Last Update Submit

January 28, 2022

Conditions

Caries,Dental

Outcome Measures

Primary Outcomes (5)

  • Cold pulp testing

    : An ice-rod will be used for this test. Results should be positive or negative.

    6 months

  • 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

  • Radiographic examination

    Indicating presence of periapical radiolucencies, widening of lamina dura, internal and external root resorption (presence/ absence).

    6 month

  • sensitivity to percussion

    recorded as yes or no

    6 month

  • visual inspection for sinus/ fistula swelling

    recorded as yes or no

    6 month

Study Arms (3)

silver nanoparticles

EXPERIMENTAL
Drug: silvernanoparticles

silverdiamine fluoride

ACTIVE COMPARATOR
Drug: SDF

no medicament

NO INTERVENTION

Interventions

silvernanoparticlesDRUG

silvernanoparticles in fluoride varnish

silver nanoparticles
SDFDRUG

silver diamine fluoride

Also known as: silver diamine fluoride
silverdiamine fluoride

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suez canal university

Suez, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Interventions

silver diamine fluoride

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

December 23, 2021

First Posted

February 9, 2022

Study Start

March 1, 2020

Primary Completion

October 1, 2020

Study Completion

March 1, 2021

Last Updated

February 9, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)