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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
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Discoloration, Tooth

Eligibility Criteria

3 Years - 5 Years (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    March 23, 2021
    Last Updated
    March 28, 2021
    Sponsor
    Cairo University
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    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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