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

NCT ID: NCT04816487

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2022-05-01

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.

Conditions

Discoloration, Tooth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Silver Diamine Flouride

Discoloration of primary carious teeth treated by SDF

Group Type: ACTIVE_COMPARATOR

Potassium Iodide or Glutathione

Intervention Type: DRUG

Patient will receive either Glutathione or Potassium iodide

Glutathione

Discoloration rate of primary carious teeth treated by SDF + Glutathione

Group Type: EXPERIMENTAL

Potassium Iodide or Glutathione

Intervention Type: DRUG

Patient will receive either Glutathione or Potassium iodide

Potassium iodide

Discoloration rate of primary carious teeth treated by SDF + KI

Group Type: EXPERIMENTAL

Potassium Iodide or Glutathione

Intervention Type: DRUG

Patient will receive either Glutathione or Potassium iodide

Interventions

Potassium Iodide or Glutathione

Patient will receive either Glutathione or Potassium iodide

Intervention Type: DRUG

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Reem Abdulaziz Hifni

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Reem Hifni

Role: CONTACT

reemhifni@gmail.com

+201060600311

Other Identifiers

Reducing discoloration of SDF

Identifier Type: -

Identifier Source: org_study_id