Standard Local AnesthesiaIntraoral CryotherapySilver Diamine Fluoride (SDF)
Standard Local Anesthesia: Local anesthesia will be administered using 1.8 mL articaine HCl with 1:100,000 epinephrine (e.g., Ultracain DS) via a standardized block anesthesia technique prior to operative treatment. (Applied in
Intraoral Cryotherapy: Cold application to the buccal mucosa adjacent to the treated tooth for 5 minutes before local anesthetic administration.
Silver Diamine Fluoride (SDF): SDF will be applied to the target tooth before local anesthetic administration according to standard clinical application procedures.
Study summary
Molar-incisor hypomineralization (MIH) is a developmental enamel defect of unclear etiology that affects permanent first molars and often permanent incisors, leading to increased porosity, hypersensitivity, and poor prognosis. The porous structure of MIH-affected enamel facilitates bacterial penetration, which may cause subclinical pulpal inflammation and reduce the effectiveness of local anesthesia during dental procedures. Achieving adequate anesthesia in children with MIH can be challenging, resulting in increased discomfort, anxiety, and behavioral management difficulties.
Cryotherapy has been shown to reduce pain by decreasing local inflammation and slowing nerve conduction, while silver diamine fluoride (SDF) has demonstrated efficacy in reducing dentin hypersensitivity through tubule occlusion, antibacterial activity, and remineralization. This study aims to evaluate the effects of intraoral cryotherapy and silver diamine fluoride application on pain perception and the efficacy of local anesthesia during operative dental procedures in MIH-affected permanent first molars.
Eligibility
Sex
ALL
Min age
6 Years
Max age
12 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* Children aged between 6 and 12 years.
* Systemically healthy children with no medical conditions that could interfere with dental treatment.
* Presence of at least one permanent first molar affected by molar-incisor hypomineralization (MIH), diagnosed according to the European Academy of Paediatric Dentistry (EAPD) criteria.
* Teeth with caries lesions classified as ICDAS II codes 2, 3, 4, 5, or 6.
* Children with an adequate level of cooperation to allow completion of dental treatment under clinical conditions.
* Children and their parents/legal guardians who have read, understood, and signed the informed consent form and agreed to participate in the study.
Exclusion Criteria:
* Teeth that are not restorable.
* Children with a known allergy or hypersensitivity to any materials used in the study, including local anesthetics, silver diamine fluoride, or restorative materials.
* Presence of spontaneous pain, percussion sensitivity, or other signs/symptoms of pulpal pathology in the study tooth.
* Children with systemic diseases or conditions that could affect pain perception, healing, or cooperation during dental treatment.
* Children who are unable or unwilling to complete the clinical procedure.
Primary outcome measure(s)
Pain intensity during dental treatment (FLACC) — Immediately after completion of the dental procedures Face, Legs, Activity, Cry, Consolability scale will be recorded. Each category is scored on the 0 to 2 scale. Add the scores together (for a total possible score of 0 to 10).
Pain intensity during operative dental treatment (Wong-Baker) — Immediately after the dental procedures were completed The patient's current pain was assessed using the Wong-Baker Faces Pain Rating Scale, with scores ranging from 0 to 5, where higher scores indicate greater pain intensity and a worse outcome, and the assessment was performed immediately after completion of the dental procedures.
Trial sites (2)
Facility
City
Region
Status
Çanakkale Onsekiz Mart University, School of Dentistry
Çanakkale
Turkey (Türkiye)
Mersin University, School of Dentistry
Mersin
Turkey (Türkiye)
More Çanakkale Onsekiz Mart University trials in Turkey
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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