Ignite Creation Date:
2024-07-17 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06489093
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-27
Brief Title:
Remineralizing Effect of Different Silver-containing Agents on Initial Caries Lesions in Primary Teeth in Children
Sponsor:
Plovdiv Medical University
Organization:
Plovdiv Medical University
Study Overview
Official Title:
Evaluation of the Effect of Green Synthesized Nano-silver Fluoride and Silver Diamine Fluoride on Carious Lesions in Children
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the present work is to study the effect of the application of Silver diamine fluoride SDF and a novel green synthesized Nano-silver fluoride NSF on early enamel lesions in primary teeth Proving their positive effect would be the basis for the development of innovative dental materials and hygienic agents to combat the carious process which is a critical prerequisite for improving the quality of dental services and reducing dental anxiety and fear
Detailed Description:
Dental caries is a major public health concern especially in very young children Early detection of the disease enhances and simplifies treatment effectiveness Non-operative treatments are particularly advantageous as they are minimally invasive reduce future operative treatment needs and are more comfortable thereby improving overall compliance and dental experience
The aim of the study is to compare the clinical efficacy of Silver diamine fluoride SDF and laboratory prepared green synthesized Nano-silver fluoride on early enamel lesions in primary teeth
The proposed study is a randomized controlled clinical trial Included patients are healthy positive children aged from 3 to 8 years requiring non-operative treatment of incipient caries lesions on smooth surfaces of primary teeth Lesions will be assessed visually using ICDAS II Nyvad criteria and laser fluorescence LF pen
Patients are randomly assigned to one of three study groups
Group N Green synthesized Nano silver fluoride prepared in laboratory Group S SDF KI 38 Riva Star SDI Group C Control group
Prior to treatment parents are informed about the nature of the study and sign an informed consent Children are introduced to the method of conducting treatment in a style appropriate for the childs age Lesions are assesed using the ICDAS II system Nyvad criteria and laser fluorescence All patients receive professional oral hygiene with a fluoride-free brush and polishing paste Treatment of each patients respective teeth is performed following the treatment protocol of the respective agents Follow-ups are performed at 1st 3rd 6th and 12th month
The aim of the study is to compare the clinical efficacy of Silver diamine fluoride SDF and laboratory prepared green synthesized Nano-silver fluoride on early enamel lesions in primary teeth
The proposed study is a randomized controlled clinical trial Included patients are healthy positive children aged from 3 to 8 years requiring non-operative treatment of incipient caries lesions on smooth surfaces of primary teeth Lesions will be assessed visually using ICDAS II Nyvad criteria and laser fluorescence LF pen
Patients are randomly assigned to one of three study groups
Group N Green synthesized Nano silver fluoride prepared in laboratory Group S SDF KI 38 Riva Star SDI Group C Control group
Prior to treatment parents are informed about the nature of the study and sign an informed consent Children are introduced to the method of conducting treatment in a style appropriate for the childs age Lesions are assesed using the ICDAS II system Nyvad criteria and laser fluorescence All patients receive professional oral hygiene with a fluoride-free brush and polishing paste Treatment of each patients respective teeth is performed following the treatment protocol of the respective agents Follow-ups are performed at 1st 3rd 6th and 12th month
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None