Effect of Glutathione vs KI in Reducing SDF Staining When Used in Treatment of Primary Carious Teeth
Primary Purpose
Discoloration, Tooth
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Potassium Iodide or Glutathione
Sponsored by
About this trial
This is an interventional treatment trial for Discoloration, Tooth
Eligibility Criteria
Inclusion Criteria:
-
Children:
- Aged 3 to 5 years, in good general health and medically free.
- The parents provided written informed consent.
- Medically free
Teeth:
- Carious primary teeth
- Restorable teeth.
- Teeth are not pulpally involved
Exclusion Criteria:
Children:
- with a history of allergy to silver
- Unable to attend follow-up visits.
- Refusal of participation.
Teeth:
- Previously restored teeth.
- Periapical swelling and tenderness in this area.
- With mobility.
- With spontaneous pain.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Silver Diamine Flouride
Glutathione
Potassium iodide
Arm Description
Discoloration of primary carious teeth treated by SDF
Discoloration rate of primary carious teeth treated by SDF + Glutathione
Discoloration rate of primary carious teeth treated by SDF + KI
Outcomes
Primary Outcome Measures
Colour assessment
Using Vita easy shade ( continuous) ΔE
Secondary Outcome Measures
Parenteral satisfaction
Direct using questionnaires Binary (Yes/No)
3-Side effects Gum swelling Gum bleaching Tooth or gum pain Nausea 3-Side effects Gum swelling Gum bleaching Tooth or gum pain Nausea 3-Side effects Gum swelling Gum bleaching Tooth or gum pain Nausea Side effects
Direct using questionnaires Binary (Yes/No)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04816487
Brief Title
Effect of Glutathione vs KI in Reducing SDF Staining When Used in Treatment of Primary Carious Teeth
Official Title
Effect of Glutathione vs Potassium Iodide in Reducing Silver Diamine Flouride Staining When Used in Treatment of Primary Carious Teeth
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2021 (Anticipated)
Primary Completion Date
August 1, 2021 (Anticipated)
Study Completion Date
May 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Although black staining is considered a drawback that is clinically observed following SDF application and is the main primary barrier for its use clinically . Child's behaviour and cooperation cannot be controlled at a young age or in special health care needs cases. Therefore, the best treatment modality will always be a simple, fast and painless procedure and SDF is the best solution for those cases. Discolouration caused researchers to search for a solution that will reduce or prevent discolouration using KI and GSH. A systematic review was conducted in-vitro, and it showed the use of SDF with KI had reduced stains markedly, potential advantages of minimal staining might be advantageous, along a short period. However, studies with long-term follow-up would be required to provide evidence-based guidelines for using SDF and KI formulations in routine clinical practice
Detailed Description
Early childhood caries (ECC) has been increasing worldwide and became a significant health problem. ECC is a multifactorial disease result from the interaction of different factors as cariogenic microorganisms, exposure to fermentable carbohydrates through inappropriate feeding habits. It affects teeth that are less susceptible to caries. The management of ECC is expensive, often requiring extensive restorative treatment such as the drill and fill technique and extraction of teeth at an early age. Nowadays, non-invasive treatment for arresting untreated dental caries is becoming urgently needed.
Silver diamine fluoride (SDF) treatment offers an alternative non-invasive treatment for caries as it arrests caries progression. S.D.F. is a colourless agent in the form of liquid with an alkaline PH of 10 it contains 24.4% to 28.8% (weight/volume) silver and 5.0 to 5.9% fluoride .. SDF is inexpensive treatment, and its ease of the application makes it a durable treatment option in dental clinics. Arresting active caries is an essential treatment modality and requires training by all dental auxiliaries.
The major drawback to SDF treatment has been its black stain and discolouration, which has limited its use. The precipitation of silver by-products in the dental tissues results in black staining, which can be discouraging and limits its use in visible areas. SDF also temporarily stains skin and gingiva, requiring them to be handled carefully to avoid contact with these tissues. To overcome the staining, SDF researchers investigated applying a saturated solution of potassium iodide (10% weight % KI) and studied the effect of glutathione (GSH) biomolecule on reducing of enamel and dentin discolouration.
Potassium iodide (KI) is used as a nutritional supplement. A supersaturated solution of KI is used in managing the discolouration problem of the carious lesion without affecting its caries arresting effect. It reduces the staining caused by the SDF as silver ions from the SDF solution reacts with the iodide ions present in KI solution, which results in the formation of silver iodide.
Glutathione (GSH) is a tri-peptide biomolecule, and it is considered one of the best with silver as it contains a thiol group (-SH) which has a high affinity for adsorption onto metal surfaces . GSH also forms a coat around silver particles, decreasing the aggregation of silver particles and controlling the rate of silver ion release (Homeostasis) , which reduces the discolouration of an SDF-coated tooth over time. This study was conducted to compare the effect of glutathione (GSH) versus Potassium iodide (KI) in reducing the SDF staining effect in carious primary teeth.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Discoloration, Tooth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Silver Diamine Flouride
Arm Type
Active Comparator
Arm Description
Discoloration of primary carious teeth treated by SDF
Arm Title
Glutathione
Arm Type
Experimental
Arm Description
Discoloration rate of primary carious teeth treated by SDF + Glutathione
Arm Title
Potassium iodide
Arm Type
Experimental
Arm Description
Discoloration rate of primary carious teeth treated by SDF + KI
Intervention Type
Drug
Intervention Name(s)
Potassium Iodide or Glutathione
Intervention Description
Patient will receive either Glutathione or Potassium iodide
Primary Outcome Measure Information:
Title
Colour assessment
Description
Using Vita easy shade ( continuous) ΔE
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Parenteral satisfaction
Description
Direct using questionnaires Binary (Yes/No)
Time Frame
6 months
Title
3-Side effects Gum swelling Gum bleaching Tooth or gum pain Nausea 3-Side effects Gum swelling Gum bleaching Tooth or gum pain Nausea 3-Side effects Gum swelling Gum bleaching Tooth or gum pain Nausea Side effects
Description
Direct using questionnaires Binary (Yes/No)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
-
Children:
Aged 3 to 5 years, in good general health and medically free.
The parents provided written informed consent.
Medically free
Teeth:
Carious primary teeth
Restorable teeth.
Teeth are not pulpally involved
Exclusion Criteria:
Children:
with a history of allergy to silver
Unable to attend follow-up visits.
Refusal of participation.
Teeth:
Previously restored teeth.
Periapical swelling and tenderness in this area.
With mobility.
With spontaneous pain.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reem Hifni
Phone
+201060600311
Email
reemhifni@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Effect of Glutathione vs KI in Reducing SDF Staining When Used in Treatment of Primary Carious Teeth
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