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Fluoride
Silver Diamine Fluoride vs Sodium Fluoride for Tooth Decay
Phase < 1
Waitlist Available
Research Sponsored by University of New England
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 6 month for next 3 years
Awards & highlights
Study Summary
This trial looks at the effectiveness of silver diamine fluoride (SDF) in arresting root caries in older adults.
Who is the study for?
This trial is for older adults aged 65-85 with dental crowns or bridges and decay around the crown margins. Participants should not plan to replace their crowns conventionally, must be able to follow up for at least a year, and cannot have periapical lesions, tooth pain on tapping, allergies to silver or fluoride, gingivitis, stomatitis (mouth inflammation), tooth mobility, or furcation involvement (bone loss).Check my eligibility
What is being tested?
The study tests Silver Diamine Fluoride (SDF) against Sodium Fluoride in preventing further tooth decay around the edges of dental crowns in seniors. It aims to determine which treatment is more effective at stopping cavities without surgical intervention.See study design
What are the potential side effects?
Potential side effects may include allergic reactions if sensitive to silver or fluoride. There could also be temporary staining of teeth where SDF is applied and possible irritation of gum tissue surrounding treated areas.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 6 month for next 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 6 month for next 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Tactile exam to evaluate extend of caries around tooth margin
Secondary outcome measures
DIAGOdent: laser fluorescence to aid in the detection of caries
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention groupExperimental Treatment1 Intervention
Subjects in this group will receive Silver Diamine Fluoride around their crown margins every six month for the next 3 years.
Group II: Fluoride varnish groupActive Control1 Intervention
Subjects in this group will receive fluoride varnish around their crown margins every six month for the next 3 years.
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Who is running the clinical trial?
University of New EnglandLead Sponsor
15 Previous Clinical Trials
1,713 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You do not plan to get the traditional treatment to replace a dental crown for any reason.You have a dental condition with a lesion around the root of a tooth.Teeth that hurt when touched.You are allergic to silver or fluoride.People with gum diseasePeople who have mouth sores.You have loose teeth.Participants who have dental issues involving the furcation area.You are between 65 and 85 years old and have dental crowns or bridges.The edges of your dental crown are not properly sealed.There is decay around the edges of a dental crown.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention group
- Group 2: Fluoride varnish group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could I be eligible to join this medical trial?
"Individuals aged 65 to 85 who possess dentin caries are eligible for this medical trial; 200 patients are targeted in total."
Answered by AI
Are applicants aged 60 and above admissible for participation in this trial?
"According to the enrollment requirements, eligible participants must be aged 65 or older and no more than 85 years old."
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Are researchers currently enrolling participants in this experiment?
"Information posted on clinicaltrials.gov signals that the trial is presently recruiting participants, with its initial posting appearing on June 26th 2021 and last edited October 3rd 2021."
Answered by AI
What is the maximum participant capacity for this research endeavor?
"Affirmative. The particulars of this medical study, which was initially posted on June 26th 2021, are available on the clinicaltrials.gov website – it is presently seeking 200 participants from one location."
Answered by AI
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