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

NCT03193606 | Completed

• 1 other identifier: CEBC-CU-2017-06-15
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Partial Dentin Caries Removal

Outcome Measures

Primary Outcomes (1)

• Caries remineralization. (Mineral density)

  using Density measurement tool in the Digora software

  six months

Secondary Outcomes (1)

• dentin bridge formation.

  six months

Study Arms (2)

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.

Other: nano silver fluoride solution

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.

Interventions

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

nano silver fluoride solution

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Rahma Ahmed

Giza, 002, Egypt

Location

Related 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.

  PMID: 24930870 BACKGROUND

Study Officials

• Heba Ah El deeb

  Associate professor, Conservative dentistry department Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: teaching assisstant

Model Details: split mouth randomized clinical trial

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 21, 2017
• Study Start: July 3, 2018
• Primary Completion: February 28, 2019
• Study Completion: March 1, 2019
• Last Updated: May 3, 2019

Record last verified: 2019-05

Locations

EG (1)