Effect of Glutathione vs KI in Reducing SDF Staining When Used in Treatment of Primary Carious Teeth
- Registration Number
- NCT04816487
- Lead Sponsor
- Cairo University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
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
-
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Glutathione Potassium Iodide or Glutathione Discoloration rate of primary carious teeth treated by SDF + Glutathione Silver Diamine Flouride Potassium Iodide or Glutathione Discoloration of primary carious teeth treated by SDF Potassium iodide Potassium Iodide or Glutathione Discoloration rate of primary carious teeth treated by SDF + KI
- Primary Outcome Measures
Name Time Method Colour assessment 6 months Using Vita easy shade ( continuous) ΔE
- Secondary Outcome Measures
Name Time Method 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 Direct using questionnaires Binary (Yes/No)
Parenteral satisfaction 6 months Direct using questionnaires Binary (Yes/No)