About this trial
The aim of this study is three-fold: 1. To evaluate the clinical performance of glass ionomer fissure sealants and resin fissure sealants when placed immediately after or one week following the application of silver fluoride on permanent molars affected by Molar-Incisor Hypomineralization in high caries-risk children. 2. To compare the effects of rinsing off the silver fluoride or not rinsing it off (blot-drying with cotton pellet) on sealant retention when the sealant is placed immediately after silver fluoride application, and 3. To measure the desensitizing effect of fissure sealant application following silver fluoride treatment on hypersensitive MIH molars.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients and their parents who consent to participate and have signed the informed consent form.
Patients with at least one permanent molar diagnosed with molar incisor hypomineralization based on EAPD guidelines.
Fully erupted teeth with ICDAS I or II lesions that necessitate the application of fissure sealants.
Teeth displaying demarcated opacities on the occlusal surface and at least one additional surface.
Disqualifiers
Teeth that have existing restorations or cavities.
Patients currently receiving orthodontic treatment.
Patients who are uncooperative during dental procedures.
Teeth affected by dental fluorosis or enamel defects associated with specific syndromes.
Trial design
Parallel
Treatments tested in this trial
Immediate restoration (resin- based) after blot-drying silver fluoride application
DeviceBlot-drying silver fluoride with cotton pellet followed by resin-based fissure sealant
Immediate restoration (GI- based) after blot-drying silver fluoride application
DeviceBlot-drying silver fluoride with cotton pellet followed by glass ionomer-based fissure sealant
Immediate restoration (Resin based) after rinsing silver fluoride application
DeviceRinsing silver fluoride off followed by resin-based fissure sealant
Immediate restoration (GIC) after rinsing silver fluoride application
DeviceRinsing silver fluoride off and blot-drying of fissures followed by glass ionomer-based fissure sealant
Resin based fissure sealant restoration one week after silver fluoride (AgF) application
DeviceResin based fissure sealant restoration one week after silver fluoride (AgF) application
GI- based fissure sealant restoration one week after silver fluoride (AgF) application
DeviceGI- based fissure sealant restoration one week after silver fluoride (AgF) application
Treatment groups
6
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
Retention Rate of Fissure Sealants with regard to the type of sealant and AgF pretreatment applied.
The US Public Health Service criteria (secondary caries, anatomical form, marginal adaptation, marginal discoloration) will be used for clinical evaluation of restorations. The restorations will be evaluated at baseline and 1., 6., 12., 18., 24. months. Intra-oral photos will be taken directly after treatment and at control appointments to evaluate discoloration and seconder caries under magnification.
Secondary outcomes
Incidence of Caries
The US Public Health Service criteria (secondary caries, anatomical form, marginal adaptation, marginal discoloration) will be used for clinical evaluation of restorations. The restorations will be evaluated at baseline and 1., 6., 12., 18., 24. months
Marginal Integrity of Sealants
The US Public Health Service criteria (secondary caries, anatomical form, marginal adaptation, marginal discoloration) will be used for clinical evaluation of restorations. The restorations will be evaluated at baseline and 1., 6., 12., 18., 24. months
Tooth Sensitivity
The Schiff Cold Air Sensitivity Scale (SCASS) will be used at 1, 6, 12, 18 and 24 months follow-ups to assess the presence of hypersensitivity in affected teeth by applying an air blast perpendicularly on the occlusal surface of the tooth for 1 second at a distance of 1 cm. The patient's response will be recorded according to the following scores: 0 = subject does not respond to the stimulus; 1. = subject does not respond to the stimulus but considers the stimulus to be painful; 2. = subject responds to the air stimulus and moves away from the stimulus; and 3 = subject responds to the air stimulus, moves away from the stimulus, and requests an immediate cessation of the stimulus
Color and esthetic Changes
Discoloration of the restorations will be recorded at 1, 6, 12, 18, and 24 months follow-ups.
Sponsors and contacts
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