Discoloration, ToothNCT04816487
Effect of Glutathione vs KI in Reducing SDF Staining When Used in Treatment of Primary Carious Teeth
A study testing Potassium Iodide or Glutathione in people with Discoloration, Tooth, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Discoloration, Tooth
- What is being tested?
- Potassium Iodide or Glutathione
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- -
- Children:
- Aged 3 to 5 years, in good general health and medically free.
- The parents provided written informed consent.
- Medically free
- Teeth:
Show all 9Show fewer
- Carious primary teeth
- Restorable teeth.
- Teeth are not pulpally involved
Who cannot join
- Children:
- with a history of allergy to silver
- Unable to attend follow-up visits.
- Refusal of participation.
- Teeth:
- Previously restored teeth.
Show all 9Show fewer
- Periapical swelling and tenderness in this area.
- With mobility.
- With spontaneous pain.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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
- Being tested
- Potassium Iodide or Glutathione
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potassium Iodide or GlutathioneDrug
Patient will receive either Glutathione or Potassium iodide
| Study group | Role | What they receive |
|---|---|---|
| Silver Diamine Flouride | Active comparator | Discoloration of primary carious teeth treated by SDF Receives: Drug: Potassium Iodide or Glutathione |
| Glutathione | Experimental | Discoloration rate of primary carious teeth treated by SDF + Glutathione Receives: Drug: Potassium Iodide or Glutathione |
| Potassium iodide | Experimental | Discoloration rate of primary carious teeth treated by SDF + KI Receives: Drug: Potassium Iodide or Glutathione |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colour assessment
Using Vita easy shade ( continuous) ΔE
Measured: 6 months
Secondary outcomes (2)
Parenteral satisfaction
Direct using questionnaires Binary (Yes/No)
Measured: 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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start1 May 2021 (estimated)
- Primary completion1 Aug 2021 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Discoloration, ToothStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reem Abdulaziz Hifni, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816487
- Sponsor's protocol ID
- Reducing discoloration of SDF
- Status last verified
- Mar 2021
- First submitted
- 23 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Glutathione vs Potassium Iodide in Reducing Silver Diamine Flouride Staining When Used in Treatment of Primary Carious Teeth
- ClinicalTrials.gov ID
- NCT04816487
- Acronym / sponsor ID
- Reducing discoloration of SDF
- Conditions
- Discoloration, Tooth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Silver Diamine Flouride | Active comparator | Drug: Potassium Iodide or GlutathioneDiscoloration of primary carious teeth treated by SDF |
| Glutathione | Experimental | Drug: Potassium Iodide or GlutathioneDiscoloration rate of primary carious teeth treated by SDF + Glutathione |
| Potassium iodide | Experimental | Drug: Potassium Iodide or GlutathioneDiscoloration rate of primary carious teeth treated by SDF + KI |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- -
- Aged 3 to 5 years, in good general health and medically free.
- The parents provided written informed consent.
- Medically free
- Carious primary teeth
Key exclusion criteria (9 listed)
- Children:
- Previously restored teeth.
- Periapical swelling and tenderness in this area.
- With mobility.
- With spontaneous pain.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Potassium Iodide or GlutathionePatient will receive either Glutathione or Potassium iodide | Drug | Glutathione, Potassium iodide, Silver Diamine Flouride |
Primary outcome
Colour assessment
Time frame: 6 months
Using Vita easy shade ( continuous) ΔE
2 secondary outcomes
Parenteral satisfaction
Time frame: 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
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Potassium Iodide or Glutathione in people with Discoloration, Tooth, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reem Hifni (+201060600311, reemhifni@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colour assessment (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.