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Comparison of Silver Diamine Fluoride and Sodium Fluoride Varnish to Prevent and Arrest Root Caries in Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04432415
Recruitment Status : Suspended (Coronavirus Pandemic)
First Posted : June 16, 2020
Last Update Posted : June 16, 2020
Sponsor:
Collaborator:
Sistema para el Desarrollo Integral de la Familia
Information provided by (Responsible Party):
Aida Borges, Universidad Nacional Autonoma de Mexico

Brief Summary:

Dental caries (coronal and root) is highly prevalent in older adults. It is important to identify and implement the most effective methods that prevent the formation of root caries lesions and inhibit existing lesions at the community level.

A clinical trial will be conducted in three groups of adults 60 years old and older, comparing the application of silver diamine fluoride solution and sodium fluoride varnish in dental root surfaces with caries and sound root surfaces. The objectives are to determine over a 30-month period which of the two agents is most effective in reducing the incidence of root caries, and which is most effective in arresting active root caries lesions.

Hypothesis: the incidence of root caries will be lower in the group of subjects treated with silver diamine fluoride compared to sodium fluoride varnish. The arrest of active root lesions will be higher when using silver diamine fluoride compared to sodium fluoride varnish.

Signed informed consent will be requested from persons 60 years and over, residents of four long-term care centers and attendees of a day care center in four central states of Mexico: Mexico City, Cuernavaca City, Oaxaca City and Toluca City. All facilities are administered by the National System for Integral Family Development (IFD), a public welfare institution that works at the federal and state levels.

Three groups will be formed (60 participants in each), two groups will be administered each of the agents, the third group will be the control group. All groups will receive dental health education (oral hygiene, instructions for care and hygiene of removable dental prosthesis, information on prevention of coronal and root caries and periodontal diseases). The preventive agents will be administered according to the manufacturer's instructions. Clinical evaluations will be carried out at baseline 6, 12, 18, 24 and 30 months. The incidence of root caries among the groups will be compared with the percentage of active root lesions that were arrested and that remained inactive.

If the greater efficacy of silver diamine fluoride is proven, it can be proposed for use in caries preventive programs for older persons, reducing the risk of tooth loss and improving quality of life. It will also serve as a guide for dental surgeon in-office decision-making regarding the method to use to prevent and limit root caries lesions in older adults at risk.


Condition or disease Intervention/treatment Phase
Root Caries Device: Silver Diamine Fluoride Device: Soduim Fluoride Varnish Device: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be assigned randomly into treatment and control group using a randomization protocol.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants will not know which type of fluoride they are getting. Outcome assesor will not know the type of fluoride or placebo assigned to each group
Primary Purpose: Prevention
Official Title: Comparison of the Efficacy of Silver Diamine Fluoride Solution and Sodium Fluoride Varnish for the Prevention and Arrest of Root Caries in a Group of Older Adults
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : July 31, 2019
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

Arm Intervention/treatment
Experimental: Group Silver Diamine Fluoride
Participants receive Annual applications of 38% SDF solution and semestral applications of artificial saliva and a personalized dental health education program.
Device: Silver Diamine Fluoride
Annual application od Silver Diamine Fluoride

Experimental: Group Sodium Fluoride Varnish
Participants receive semestral applications of Sodium Varnish Fluoride and a personalized dental health education program.
Device: Soduim Fluoride Varnish
biannual apllication of Sodium Fluoride Varnish

Placebo Comparator: Placebo
Participants receive semestral apllications of artificial saliva and a personalized dental health education program.
Device: Placebo
biannual application of artificial saliva




Primary Outcome Measures :
  1. Incidence of root caries lesions [ Time Frame: 30 months ]
    Number of new caries lesions


Secondary Outcome Measures :
  1. Arrested root caries lesions [ Time Frame: 30 months ]
    number of active root caries lesions arrested (non active)



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Adults 60 years of age and older
  • At least 5 teeth with gingival recession and exposed root surfaces not indicated for extraction
  • No problems performing activities of daily living
  • Agree to participate and sign the informed consent.

Exclusion criteria:

  • Health problems that prevent oral hygiene
  • Cognitive problems that prevent understanding oral hygiene instructions
  • Salivary gland diseases (hyposalivation)
  • Having received radiation therapy to the head and neck
  • Deafness
  • Active infections of the oral mucosa
  • Allergy to silver
  • Stomatitis
  • Allergy to colophony (component of varnishes)

Elimination criteria:

-Adults who do not return to subsequent applications of silver diamine fluoride, sodium fluoride varnish, or artificial saliva.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04432415


Locations
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Mexico
Centro Gerontológico Arturo Mundet
Mexico City, Mexico, 01040
Sponsors and Collaborators
Universidad Nacional Autonoma de Mexico
Sistema para el Desarrollo Integral de la Familia
Investigators
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Principal Investigator: Aida Borges-Yañez, PhD Universidad Nacional Autonoma de Mexico
Publications:
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Responsible Party: Aida Borges, Principal investigator, Universidad Nacional Autonoma de Mexico
ClinicalTrials.gov Identifier: NCT04432415    
Other Study ID Numbers: UNAMexico CIE/0810/03/2017
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aida Borges, Universidad Nacional Autonoma de Mexico:
root caries
Fluorides
aged
incidence
Mexico
Long-Term Care
Additional relevant MeSH terms:
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Root Caries
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Fluorides, Topical
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs