Root Caries Clinical Trial
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
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.
There is an increase in the incidence and prevalence of chronic diseases, including oral
problems in older persons. Coronal and root caries, and periodontitis represent the main
causes of tooth loss, and in older adults they have a great impact on quality of life,
nutritional status, social life, and the increased risk of systemic problems related to
dental infectious processes. At present, older adults have more remaining teeth and dental
caries is highly prevalent. It is important to investigate and implement methods that prevent
the formation of new carious lesions and that arrest existing lesions. The utilization of
silver diamine fluoride as a method to prevent coronal caries has been recognized and has
proven to be highly effective in treating dentin hypersensitivity and arresting active
lesions, also it is easy to apply. Therefore, it is important and necessary to implement
methods that avoid the formation of lesions and that inhibit the root caries lesions already
present.
If greater effectiveness of silver diamine fluoride in preventing and arresting active root
caries is confirmed, its use in conjunction with oral health education can be proposed as a
preventive method to be included in oral health programs in institutionalized persons in whom
dental care and attention are less frequent. Its ease of application, the longer time between
applications and its cost can facilitate better oral care. On the other hand, the results can
guide professionals in clinical practice in making decisions regarding the most appropriate
method to prevent and arrest root caries lesions in their patients.
Hypothesis The incidence of root caries (new root caries lesions) after 30 months will be
lower on root surfaces that have been treated with silver diamine fluoride solution (38%
concentration [44800 ppm]) compared to those treated with sodium fluoride varnish (5%
concentration [22,600 ppm]) and to those in the control group (artificial saliva).
The number of active root caries lesions arrested at baseline will be higher in people who
have been treated with silver diamine fluoride solution (38% concentration [44,800 ppm])
compared to those treated with sodium fluoride varnish (5% concentration [22600 ppm]) and
with the control group (artificial saliva).
General objective:
To identify whether the annual application of silver diamine fluoride solution combined with
an individualized oral health education program is more effective than biannual application
of sodium fluoride varnish combined with an individualized oral health education program and
a group control (artificial saliva and oral health individualized educational program) in the
reduction of the incidence of root caries and in the arrest of active root caries lesions
over a period of 30 months in a population of adults over 60 years of age in residents of 4
gerontological centers and a DIF day care center, in 2017-2020.
Specific objectives:
- To compare the incidence of root caries after 30 months in three groups receiving the
annual application of silver diamine fluoride solution (44800 ppm), the biannual
application of sodium fluoride varnish (22600 ppm) and the biannual application of
artificial saliva respectively, controlling for age, gender, frequency of toothbrushing,
use of dental floss, use of removable prostheses.
- To compare the number of active root carious lesions arrested at baseline after annual
application of silver diamine fluoride solution (44,800 ppm) and biannual application of
sodium fluoride varnish (22,600 ppm) and biannual application of artificial saliva, all
combined with an individualized oral health education program, controlling by age,
gender, frequency of toothbrushing, use of dental floss, use of removable prostheses.
- To design and implement an individualized oral health education program on prevention
and treatment of root and coronal caries, promotion and reinforcement of toothbrushing,
and the proper care and cleaning of removable prostheses.
METHODS Area: clinical research Study type: Intervention Study design: randomized controlled
clinical trial. Study characteristics: prospective, longitudinal, comparative. Participant
allocation: randomized Study classification: efficacy study Intervention model: parallel
groups Masking: blind (participant) Main purpose: Prevention Study population Residents of
four gerontological centers "Arturo Mundet" (Mexico City), "Vicente García Torres" (Mexico
City), "Los Tamayo" (Oaxaca, Oaxaca) and "Olga Tamayo" (Cuernavaca, Morelos ) and a day care
center in Santa Ana Tlapaltitlán (Toluca, State of Mexico). All centers are administered by
the National System for Integral Family Development, a public welfare institution that works
at the federal and state levels.
Sample size Three groups of size 60 are required, in a no probabilistic convenience sampling.
The administration will be carried out in the same way in the three groups using a mini
applicator brush.
Control group: biannual application of artificial saliva on exposed root surfaces. Sodium
Fluoride varnish: biannual application of sodium fluoride varnish (22,600 ppm) on exposed
healthy root surfaces and application at baseline and biannually on active root lesions.
Silver Diamine Fluoride: annual application of silver diamine fluoride solution (44800ppm) on
exposed healthy root surfaces and alternate annual application of artificial saliva, as well
as initial and annual application on active root lesions.
Before data collection persons will be invited to participate, the purpose of the study will
be explained, and if they accept will be examined to identify whether they meet the selection
criteria.
Once the participants have been selected and signed the informed consent, they will be
randomly assigned to one of the three groups. The baseline questionnaire on knowledge,
attitudes and practices, the clinical evaluation and the initial application of the
preventive agents or placebo, and the first personalized oral health education session will
be carried out.The clinical examination will be carried out in each center using a portable
dental unit and artificial light.
The evaluations will be repeated at 6, 12, 18, 24 and 30 months. The examiner will be
standardized for the evaluation of root caries using the International Caries Detection and
Assessment System (ICDAS) for root caries, and in the assessment of dental plaque and dental
calculus.
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