Children, Dental Caries, Molar Incisor Hypomineralisation
Conditions
Keywords
Molar Incisor Hypomineralisation, Children, Silver Fluoride, Fissure Sealant, Glass ionomer, Silver-modified atraumatic restorative treatment
Brief summary
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.
Detailed description
Teeth will be randomized in a parallel design based on the application of restoration time (immediate or one week later), sealant material type (resin or glass ionomer), and for immediate applications, the condition of silver fluoride before restoration (dried with cotton or rinsed gently). A total of 216 permanent molars will be included in the study. Randomization of molar teeth into six groups according to the restoration time, dental restorative material type, and conditions:
Interventions
DEVICEImmediate restoration (resin- based) after blot-drying silver fluoride application
Blot-drying silver fluoride with cotton pellet followed by resin-based fissure sealant
DEVICEImmediate restoration (GI- based) after blot-drying silver fluoride application
Blot-drying silver fluoride with cotton pellet followed by glass ionomer-based fissure sealant
DEVICEImmediate restoration (Resin based) after rinsing silver fluoride application
Rinsing silver fluoride off followed by resin-based fissure sealant
DEVICEImmediate restoration (GIC) after rinsing silver fluoride application
Rinsing silver fluoride off and blot-drying of fissures followed by glass ionomer-based fissure sealant
DEVICEResin based fissure sealant restoration one week after silver fluoride (AgF) application
Resin based fissure sealant restoration one week after silver fluoride (AgF) application
DEVICEGI- based fissure sealant restoration one week after silver fluoride (AgF) application
GI- based fissure sealant restoration one week after silver fluoride (AgF) application
Sponsors
Hacettepe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Randomization of molar teeth into six groups according to the restoration time, dental restorative material type, and conditions: Group 1: Restoration one week after silver fluoride application (n=72) Subgroup 1: Resin-based fissure sealant (n=36) Subgroup 2: Glass ionomer-based fissure sealant (n=36) Group 2: Immediate restoration after silver fluoride application (n=144) Subgroup 1: Blot-drying silver fluoride with cotton pellet followed by resin-based fissure sealant (n=36) Subgroup 2: Blot-drying silver fluoride with cotton pellet followed by glass ionomer-based fissure sealant (n=36) Subgroup 3: Rinsing silver fluoride off and air-drying of fissures followed by resin-based fissure sealant (n=36) Subgroup 4: Rinsing silver fluoride off and blot-drying of fissures followed by glass ionomer-based fissure sealant (n=36)
Eligibility
Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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. * Children with systemic conditions requiring ongoing medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention Rate of Fissure Sealants with regard to the type of sealant and AgF pretreatment applied. | From enrollment to the end of treatment: 14 months (from July 2023 to October 2024). The first-year outcomes are planned for October 2025, and the second-year outcomes are planned for October 2026. | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Caries | From enrollment to the end of treatment: 14 months (from July 2023 to October 2024). The first-year outcomes are planned for October 2025, and the second-year outcomes are planned for October 2026. | 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 | From enrollment to the end of treatment: 14 months (from July 2023 to October 2024). The first-year outcomes are planned for October 2025, and the second-year outcomes are planned for October 2026. | 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 | From enrollment to the end of treatment: 14 months (from July 2023 to October 2024). The first-year outcomes are planned for October 2025, and the second-year outcomes are planned for October 2026. | 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 | From enrollment to the end of treatment: 14 months (from July 2023 to October 2024). The first-year outcomes are planned for October 2025, and the second-year outcomes are planned for October 2026. | Discoloration of the restorations will be recorded at 1, 6, 12, 18, and 24 months follow-ups. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactElif Ballıkaya, DDS, PhD
Backup ContactGizem Erbas Unverdi, DDS, PhD
Outcome results
None listed