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

NCT04816487 | Unknown

• 1 other identifier: Reducing discoloration of SDF
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Conditions

Discoloration, Tooth

Outcome Measures

Primary Outcomes (1)

• Colour assessment

  Using Vita easy shade ( continuous) ΔE

  6 months

Secondary Outcomes (2)

• Parenteral satisfaction

  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

  6 months

Study Arms (3)

Silver Diamine Flouride

ACTIVE COMPARATOR

Discoloration of primary carious teeth treated by SDF

Drug: Potassium Iodide or Glutathione

Glutathione

EXPERIMENTAL

Discoloration rate of primary carious teeth treated by SDF + Glutathione

Drug: Potassium Iodide or Glutathione

Potassium iodide

EXPERIMENTAL

Discoloration rate of primary carious teeth treated by SDF + KI

Drug: Potassium Iodide or Glutathione

Interventions

Potassium Iodide or Glutathione DRUG

Patient will receive either Glutathione or Potassium iodide

Glutathione; Potassium iodide; Silver Diamine Flouride

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Tooth Discoloration

Interventions

Potassium Iodide; Glutathione

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Iodides; Iodine Compounds; Inorganic Chemicals; Potassium Compounds; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Reem Hifni

CONTACT

+201060600311; reemhifni@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 25, 2021
• Study Start: May 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: May 1, 2022
• Last Updated: April 1, 2021

Record last verified: 2021-03