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Clinical Trials/NCT03193606
NCT03193606CompletedNot Applicable

Radiographic Assessment of Glass Ionomer Restorations With and Without Prior Application of Nano Silver Fluoride in Occlusal Carious Molars Treated With Partial Caries Removal Technique (Randomized Clinical Trial)

Cairo University1 site in 1 country22 target enrollmentStarted: July 3, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
22
Locations
1
Primary Endpoint
Caries remineralization. (Mineral density)

Study Overview

Brief Summary

eligible teeth will be randomly divided into two groups to be treated with incomplete caries excavation (A), where (A1) represents teeth to be treated with application of Nano silver fluoride solution on remaining carious dentin prior to final permanent glass ionomer restoration application, (A2) represents comparator group to be restored without Nano silver fluoride application prior to restoration. Every participant will receive both the intervention and control treatment. Image of radiographic density of remaining carious dentin will be evaluated using PSP plate at baseline immediately after restoration and after 6 months after restorative procedures.

The null hypothesis tested is that application of Nano silver fluoride solution prior to glass ionomer restoration will not increase radiopacity of the underlying dentin treated by incomplete carious removal technique compared to that of direct glass ionomer restoration without prior application of Nano silver fluoride.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
16 Years to 35 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Patients presenting with at least 2 teeth with active carious lesions limited to the occlusal surface of molars at risk of pulp exposure during direct complete excavation (primary caries lesion involving more than half of the entire dentin thickness determined radiographically).
  • •Signs and symptoms indicative of pulp vitality, i.e. a positive response to thermal stimulation during a cold test
  • •Absence of apical pathosis, clinical diagnosis of pulp exposure, fistula, swelling of periodontal tissues.

Exclusion Criteria

  • •Teeth with spontaneous pain or sensitivity to percussion.
  • •Teeth with periodontal lesions, internal or external root resorption, mobility of tooth, sinus opening, or abscessed tooth.
  • •Radiographic examination revealed, interrupted or broken lamina dura, widened periodontal ligament space, periapical radiolucency.
  • •patients with systemic medical conditions
  • •pregnant females

Arms & Interventions

no nano silver fluoride

No Intervention

carious dentin to be treated with partial caries excavation without application of nano silver fluoride solution restored directly with glass ionomer.

nano silver fluoride solution

Experimental

carious dentin to be treated with partial caries excavation with application of nano silver fluoride solution prior to glass ionomer restoration.

Intervention: nano silver fluoride solution (Other)

Outcomes

Primary Outcomes

Caries remineralization. (Mineral density)

Time Frame: six months

using Density measurement tool in the Digora software

Secondary Outcomes

  • dentin bridge formation.(six months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rahma Ahmed Ibrahem Hafiz

teaching assisstant

Beni-Suef University

Study Sites (1)

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