Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03193606
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Rahma Ahmed Ibrahem Hafiz, Beni-Suef University

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.


Condition or disease Intervention/treatment Phase
Partial Dentin Caries Removal Other: nano silver fluoride solution Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: split mouth randomized clinical trial
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : July 3, 2018
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: nano silver fluoride solution
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
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

No Intervention: no nano silver fluoride
carious dentin to be treated with partial caries excavation without application of nano silver fluoride solution restored directly with glass ionomer.



Primary Outcome Measures :
  1. Caries remineralization. (Mineral density) [ Time Frame: six months ]
    using Density measurement tool in the Digora software


Secondary Outcome Measures :
  1. dentin bridge formation. [ Time Frame: six months ]
    Linear measurement tool in the Digora software in Mm



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193606


Locations
Layout table for location information
Egypt
Rahma Ahmed
Giza, Egypt, 002
Sponsors and Collaborators
Cairo University
Investigators
Layout table for investigator information
Study Director: Heba Ah El deeb Associate professor, Conservative dentistry department Cairo University

Publications:
Layout table for additonal information
Responsible Party: Rahma Ahmed Ibrahem Hafiz, teaching assisstant, Beni-Suef University
ClinicalTrials.gov Identifier: NCT03193606     History of Changes
Other Study ID Numbers: CEBC-CU-2017-06-15
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Pharmaceutical Solutions
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs