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OpenTrials
Completed

NCT Number: NCT03193606

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

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.

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Key information

Conditions

Partial Dentin Caries Removal

Age range

16 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rahma Ahmed

Giza, 002, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nano silver fluoride solution

Other

prepared Nano-silver fluoride could have the capability to arrest caries. As its Nano silver particles have an antimicrobial activity against Mutans Streptococci and Lactobacilli; the main pathogens involved in the development of carious lesions. In addition, its fluoride component is well known to enhance remineralization and inhibit bacterial activity. So, Nano silver fluoride could be a promising solution to combat residual bacteria in tooth cavity with effective remineralization potential on remaining carious dentin

Primary outcomes

  1. Caries remineralization. (Mineral density)

    Time frame: six months

    using Density measurement tool in the Digora software

Secondary outcomes

  1. dentin bridge formation.

    Time frame: six months

    Linear measurement tool in the Digora software in Mm

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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)

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 21, 2017
Registry last updated
May 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.