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

Partial Dentin Caries Removal Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03193606
• Other study ID #: CEBC-CU-2017-06-15
• Status: Completed
• Phase: N/A
• Start date: July 3, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: May 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 1, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Partial Dentin Caries Removal

Intervention

Other:
• nano silver fluoride solution
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

Locations

Country	Name	City	State
Egypt	Rahma Ahmed	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Santos VE Jr, Vasconcelos Filho A, Targino AG, Flores MA, Galembeck A, Caldas AF Jr, Rosenblatt A. A new "silver-bullet" to treat caries in children--nano silver fluoride: a randomised clinical trial. J Dent. 2014 Aug;42(8):945-51. doi: 10.1016/j.jdent.2014.05.017. Epub 2014 Jun 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caries remineralization. (Mineral density)	using Density measurement tool in the Digora software	six months
Secondary	dentin bridge formation.	Linear measurement tool in the Digora software in Mm	six months