Effect of Glutathione vs KI in Reducing SDF Staining When Used in Treatment of Primary Carious Teeth

Effect of Glutathione vs Potassium Iodide in Reducing Silver Diamine Flouride Staining When Used in Treatment of Primary Carious Teeth

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

Study Overview

• Status: Not yet recruiting
• Conditions: Discoloration, Tooth
• Intervention / Treatment: Drug: Potassium Iodide or Glutathione

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Reem Hifni; Phone Number: +201060600311; Email: reemhifni@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 5 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Silver Diamine Flouride; Discoloration of primary carious teeth treated by SDF	Drug: Potassium Iodide or Glutathione; Patient will receive either Glutathione or Potassium iodide
EXPERIMENTAL: Glutathione; Discoloration rate of primary carious teeth treated by SDF + Glutathione	Drug: Potassium Iodide or Glutathione; Patient will receive either Glutathione or Potassium iodide
EXPERIMENTAL: Potassium iodide; Discoloration rate of primary carious teeth treated by SDF + KI	Drug: Potassium Iodide or Glutathione; Patient will receive either Glutathione or Potassium iodide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Colour assessment	Using Vita easy shade ( continuous) ΔE	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parenteral satisfaction	Direct using questionnaires Binary (Yes/No)	6 months
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)	6 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2021
• Primary Completion (ANTICIPATED): August 1, 2021
• Study Completion (ANTICIPATED): May 1, 2022

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (ACTUAL): March 25, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 28, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Discoloration
• Other Study ID Numbers: Reducing discoloration of SDF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No