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Dental caries is a multifactorial, progressive disease which is the major causes of dental pain, infection and tooth loss. Dental caries can substantially compromise the quality of life in older adults 1 2. As the number of older adults in the US increases, the dental professionals have become increasingly concerned with the dental need of elderly and preventive regimes to reduce the incidence of caries3 .
Prevention becomes an area of paramount importance. Many studies have advocated nonsurgical intervention for shallow dentin caries lesion.The most effective method for prevention to date is considered to be fluoride. In the United states fluoride has been incorporated in many ways like water fluoridation, fluoride mouth wash, dentifrices and professionally applied fluoride varnishes . The American Dental Association (ADA) recommended the use of fluoride for patients of all ages who are at risk of developing dental caries7 . With the high success of fluoride, another treatment method using Silver Diamine Fluoride (SDF) is gaining popularity in the United States. SDF has been used in many countries like Japan, Australia, China, and Cuba for treatment of caries . Successful treatment data from other countries is promising, and promoting the use of SDF in the United States. SDF is available in the United States as 38% aqueous solution and approved as a desensitizing agent. American Dental Association published an evidence-based clinical practice guideline on nonrestorative treatments for caries teeth and recommended use of SDF on a carious cavitated lesion on permanent teeth9 . Clinical studies have shown the effectiveness of SDF in arresting root caries in older adults.
Potential subjects will be identified through regular appointments. Screening will be performed on subjects to determine their eligibility based on inclusion and exclusion criteria. Subjects will sign an informed consent before enrollment in the study. Patient will be receiving one of the two fluoride treatments, Silver Diamine Fluoride or Sodium fluoride, to arrest caries around crown margins. Clinical and radiographic exam will be performed on all the participants.
Clinical exam will include the following
The procedures of every clinical appointments will be as following:
First appointment:
Visit will include
Second visit (6 month from the first appointment ):
Visit will include
Third visit (12 month from the first appointment ):
Visit will include
Third visit (12 month from the first appointment ):
Visit will include
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Subjects in this group will receive Silver Diamine Fluoride around their crown margins every six month for the next 3 years. |
|
| Fluoride varnish group | Active Comparator | Subjects in this group will receive fluoride varnish around their crown margins every six month for the next 3 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silver Diammine Fluoride | Drug | Subjects will receive SDF around their crown margins every 6 months for next 3 years. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tactile exam to evaluate extend of caries around tooth margin | WHO ball end probe will be used to detect cavities around the restoration margins. Code 0: Sound tooth surface with restoration Code 1: First visual change in enamel Code 2: Distinct visual change in enamel/ dentin adjacent to restoration Code 3: Carious defect of more than 0.5 mm Code 4: Marginal caries in enamel/dentin/cementum adjacent to restoration with dark shadow Code 5: Distinct cavity adjacent to restoration Code 6: Extensive distinct cavity with visible dentine | Every 6 month for next 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| DIAGOdent: laser fluorescence to aid in the detection of caries | As the incident laser light is dispersed into the site, carious tooth structure will exhibit fluorescence, proportionate to the degree of caries, resulting in elevated scale readings on the display. Healthy tooth structure exhibits little or no fluorescence and will result in very low scale readings on the display. Over 90% accurate in detecting lesions not detectable with an explorer or bitewing X-rays. The remote display for DIAGNOdent pen uses infra-red signals, and the values are shown simultaneously on the DIAGNOdent pen and on the remote display |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shaista Rashid, B.D.S, M.S. | Contact | 2072214861 | srashid2@une.edu | |
| Mohamed ElSalhy, MPH, PHD | Contact | 2072214862 | melsalhy@une.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New England | Recruiting | Portland | Maine | 04101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28888414 | Background | Giusti L, Steinborn C, Steinborn M. Use of silver diamine fluoride for the maintenance of dental prostheses in a high caries-risk patient: A medical management approach. J Prosthet Dent. 2018 May;119(5):713-716. doi: 10.1016/j.prosdent.2017.06.007. Epub 2017 Sep 6. | |
| 31299955 | Result | Seifo N, Cassie H, Radford JR, Innes NPT. Silver diamine fluoride for managing carious lesions: an umbrella review. BMC Oral Health. 2019 Jul 12;19(1):145. doi: 10.1186/s12903-019-0830-5. |
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Participants will be assigned randomly into treatment and control group using a predetermined randomization protocol.
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Participants will not know which type of fluoride they are getting around their crow margins.
Principal investigator will measuring the extend of the decay does not know about the type of fluoride treatment patient got.
| Fluoride Varnishes | Drug | Subjects will receive SDF around their crown margins every 6 months for next 3 years. |
|
| Every 6 month for next 3 years |
| ID | Term |
|---|---|
| D017213 | Root Caries |
| ID | Term |
|---|---|
| D003731 | Dental Caries |
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C024633 | silver diamine fluoride |
| D005460 | Fluorides, Topical |
| ID | Term |
|---|---|
| D005459 | Fluorides |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D007287 | Inorganic Chemicals |
| D002327 | Cariostatic Agents |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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