Caries Prevention Clinical Trial
Official title:
Effectiveness of Using a Light Curable Resin Modified Glass Ionmer Cement Varnish (Vanish XT) in Prevention of Occlusal Caries: a Randomized Controlled Clinical Trial
Despite the continuous effort to prevent and treat dental caries, it continues to be one of
the most common chronic diseases in both children and adults. Prevention and minimally
intervention treatment by early detection of the lesion are becoming the new philosophy in
managing dental caries. The prevalence of pit and fissure caries was found to be 90% of all
dental caries in permanent molars. Moreover, the risk of caries development is higher soon
after the tooth had erupted.
The purpose of the current study is; to evaluate the effectiveness of a resin-modified glass
ionmer cement (Vanish XT) varnish in the prevention of occlusal caries and compare it to a
fluoride varnish in newly erupted first permanent molars.
material and method: The sample will comprise of 84 bilateral pairs of newly erupted first
permanent molars in children with age of 6-9 years.This sample will be randomly selected
after patient's screening from pediatric dentistry clinics at King Abdul-Aziz University
Dental Hospital, Jeddah, Saudi Arabia. Informed written consent will be obtained from the
parents prior to sampling.
Healthy children with all four first permanent molar will be included in the study. Children
must have at least one pair of contralateral newly erupted first permanent molars free from
caries. Teeth with deep pits and fissures free of caries, restorations, sealants, fracture,
hypoplasia, or cracks will be included in the study.
The children who met the inclusion criteria will be enrolled in the trial after a signed
consent form is obtained. Pairs of maxillary or mandibular first molars will be included so
that one side will be randomly assigned to study group and the contralateral side to control
group.
Study group: This group will consist of 84 first permanent molars. These molars will be
sealed using light curing resin-modified glass ionomer varnish (ClinproTM XT Vanish, 3M ESPE,
Dental Products, St. Paul, MN, USA)
Control group: This group will consist of 84 first permanent molars. These molars will
receive 5% Sodium Fluoride (NaF) with Tri-Calcium Phosphate topical varnish (Vanish White
Varnish, 3M ESPE, Dental Products, St. Paul, MN, USA). These molars will serve as a control
group.
The clinical examination will be assessing the caries lesions at baseline and 3,6, 12, and 18
months by the trained and calibrated dentists' according to ICDAS II criteria (International
Caries Detection and Assessment System). Teeth with deep pits and fissures, which scored 0
will be included in this study.
In addition, once the clinical examination is done, bitewing radiographs will be taken for
each child on the first visit to diagnose caries at the baseline.
A child structured questionnaire to be completed by interviewing the parents (adopted from
WHO Oral Health Questionnaire for Children) concerning the dental history of the child and
oral hygiene habits will be given at the baseline and at each recall visit.
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