Rationale and background
information
Introduction: Dental caries is the most
common oral disease in children and adolescents1. Literature
indicates that more than 50% of carious lesions occurring among school children
involve occlusal surface which is attributed to the presence of deep pits and
fissures with their irregularities and invaginations2. The
topography of fissures makes mechanical removal of plaque bacteria from tooth
surface difficult. Fluorides in different forms are most effective in
preventing caries on smooth and proximal surfaces. However, they are less
effective on occlusal surfaces. Pits and fissures are eight times more
vulnerable to become carious in comparison with smooth surfaces.3 Current
concept of minimally invasive dentistry emphasizes the need to focus on
prevention rather than treatment of an established disease. The sealing with an
occlusal barrier isolates the occlusal surface from the surrounding environment
preventing the onset of caries.
Statement of the problem/Hypothesis: Pit and fissure sealants are an ideal way of
preventing dental caries on occlusal pits and fissures. Although, four different types of sealants namely resin based sealants,
glass Ionomer based sealants, resin modified glass Ionomer sealants and
polyacid modified resin sealants are widely used for preventing occlusal caries
among susceptibles,4-12 current evidence on comparative
effectiveness of different types of sealants is very weak according to a
systematic review by American Dental Association and American Academy of
pediatric dentistry.13 This highlights the need for clinical trials
that compare the effectiveness of different types of sealants in preventing
dental caries. Hence, this study is undertaken to compare retention and
effectiveness of four different types of sealants (resin based, glass ionomer
based, resin modified glass ionomer and polyacid modified resin sealants) in
preventing dental caries on occlusal surfaces of permanent first and second
molars and premolars among 6-14 years old children selected from orphanages of Mysuru
city.
Purpose and significance of Research: The newly erupted molars and premolars are highly susceptible to caries, and
this is the time at which sealants are highly advisable especially among lower
class children who are at high risk for dental caries. This research provides
an opportunity to offer primary preventive service (sealant application) for
children from selected orphanages of Mysuru city who are otherwise are deprived
of such services while facilitating us to evaluate and compare sealant
retention between four different types of sealants.
Aim
&Objectives
Aim: To compare the retention and effectiveness of four different types of
sealants (resin based, glass ionomer based, resin modified glass ionomer and
polyacid modified resin-based sealants) in preventing dental caries on occlusal
surfaces of permanent first and second molars and premolars among 6-14 years
old children selected from orphanages in Mysuru city.
Objectives:
1.
To
identify and undertake pit and fissure sealant application in first and second
permanent molars and premolars using four different types of sealants (resin-based
sealants, glass ionomer-based sealants, resin modified glass ionomer sealants
and polyacid based resin sealants) among 6 -14 years old school children selected from orphanages in Mysuru city.
2.
To
evaluate and compare sealant retention and its effectiveness in preventing
dental caries increments between four different types of sealants during the 18
months follow up period.
3. To provide strategic recommendation
on the sealant ideally suited for application in field settings such as orphanages
where sophisticated dental equipment may not be available.
MethodologyData collection procedure
Type
& duration of study:
This will be a split mouth double blind randomized
control trial conducted over a period of 24 months.
Study setting & source of data: The study will be conducted among 6-14 years old children selected from orphanages in Mysuru city.
Ethical clearance and informed consent: Study will be conducted
in accordance with the guidelines of Declaration of Helsinki for biomedical
research involving human subjects (World Medical Association Declaration of
Helsinki, 2001). Ethical
clearance will be obtained from Institutional Ethics Committee (IEC). Data will be collected after
taking consent from the wardens/caretakers of these children. An assent from
children will also be taken before recruiting the children into the study.
Permission will be obtained from the headmaster of the school.
Sample size and its estimation including sampling
procedure: Sample size was estimated using
nMaster software (Department of Biostatistics, Christian Medical College,
Vellore) for Repeated measures Analysis of Variance (With intra class
correlation coefficient - ICC) between four different time intervals. The
sample size was estimated to be 29 teeth per group at an assumed within group
variance of 0.2, between group variance of 0.5, intra class correlation
coefficient of 0.8, effect size of 0.6, 80% power and 5% level of significance.
However, the sample size was rounded off to 35 teeth per group to compensate
for an anticipated 20% loss to follow up.
An
orphanage housing students in the age range of 6-14 years will be identified.
All the children in this orphanage will be screened by a trained investigator
to identify children in the age range of 6-14 years who require sealant application
in at least four teeth (first and second permanent molars and premolars) in
their mouth. Children from other orphanages will be considered if required
number of eligible children are not available in the selected orphanage.
Sample
selection criteria:
Inclusion
criteria:
1. Children with permanent molars and
premolars with deep pits and fissures
2. Children with at least four permanent
molars and premolars requiring sealant applications
3. Children who are willing to
participate in the study with consent from their wardens/caretakers
Exclusion criteria:
1. Children with gross oral defects
which interfere with mastication resulting in unilateral mastication
2. Children presenting with generalized
attrition of permanent teeth indicating bruxism
3. Uncooperative children not willing to
offer assent
4. Children not available for follow up
examinations
Withdrawal criteria: Children experiencing any unanticipated side effects
following intervention. Such
children will be offered required care by the investigator.
Trial registration:
The trial will be registered with clinical trial registry of India. The trial
will be carried out in accordance with the guidelines of declaration of
Helsinki.
Baseline
data collection: A structured close ended
questionnaire will be used to document demographic details, oral hygiene
practices, dietary habits, medical and dental history. A sterile mouth mirror,
explorer and CPITN probe will be used for clinical oral examination of
children. Examination will be performed on a portable dental chair under adequate
illumination within the premises of orphanage.
Randomization
and intervention: The selected children
will be provided sealant application using four different types of sealants by
a single trained investigator. Computer generated random allocation sequence
will be used for assigning the type of sealant to be applied for four different
teeth within the same mouth. The random allocation will be undertaken by the
coordinator of the trial.
A child requiring four sealant
applications in his/her mouth will be given four different types of sealants
(resin-based sealant, glass ionomer-based sealant, resin modified glass ionomer
sealant and polyacid based resin sealant) in four different teeth according to
the manufacturer’s instructions.
The following sealants which are
commercially available will be applied
1.
Resin based- 3m Espe Clinpro Sealant
2.
GIC based- Gc Fuji 7 Sealant
3.
Resin modified GIC- HY Bond resiglass SHOU
4.
Polyacid modified resin- Dyract seal
Blinding:
Details of
randomization will be concealed from the investigator involved in follow up
examination of children. Data sheets compiled during the study period at
different time intervals will be kept confidential till the completion of study
to ensure blinding.
Follow up examinations: Follow up examinations
will be undertaken at intervals of six months for 18 months following
intervention by one calibrated investigator who is not involved in
intervention.
Sealant retention and caries status in the
sealed teeth following intervention will be assessed using modified Simonsen’s
criteria.14
Score 0: No loss of sealant and no evidence
of caries
Score 1: Partial loss of sealant and no
evidence of caries
Score 2: Partial loss of sealant and evidence
of caries
Score 3: Complete loss of sealant and no
evidence of caries
Score 4: Complete loss of sealant and
evidence of caries
Re-application of sealants:
Children with partially or completely lost sealants who require reapplication
of sealants will be offered the same type of sealant that was offered at the
time of intervention by the same investigator. Number of such reapplications
undertaken over a period of 18 months for different teeth in each child will be
documented in their data collection sheets.
Data
analysis procedure
Statistical methods: Data
analysis will be done using SPSS 24.0. Comparison of proportion of sealants
retained, sealant failures and new caries increments between the four sealant
groups will be done at each time interval using Pearson’s Chi square test.
Comparison of proportion of sealants retained, sealant failures and caries
increment in each group between baseline and subsequent follow up examinations
will be done using Friedman’s test. Mean number of teeth requiring
reapplication of sealants between the four different sealant groups at each
time interval will be compared using one way Analysis of variance and Tukey’s
post hoc test. Effect size indicating the magnitude of difference will be
computed. Statistical significance will be fixed at 0.05.
Expected
outcome and social relevance/Implications: This randomized control trial will add to the
existing body of evidence on the comparative effectiveness of four different
types of sealants which in fact is week at present, while facilitating us to
evaluate and identify the ideal sealant type that could be recommended in these
kinds of field settings. Underprivileged children from these orphanages will be
offered preventive procedures which they would not have received
otherwise.
References
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