Effects of Silver Diamine Fluoride and Intraoral Cryotherapy on Local Anesthesia in MIH-Affected Molars

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorÇanakkale Onsekiz Mart University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard Local Anesthesia

    Other intervention

    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

    Other intervention

    Cold application to the buccal mucosa adjacent to the treated tooth for 5 minutes before local anesthetic administration.

  • Silver Diamine Fluoride (SDF)

    Other intervention

    SDF will be applied to the target tooth before local anesthetic administration according to standard clinical application procedures.

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: Control (Standard Local Anesthesia)Active comparator 1 intervention
Group B: Intraoral Cryotherapy + Standard Local AnesthesiaExperimental treatment 2 interventions
Group C: Silver Diamine Fluoride (SDF) + Standard Local AnesthesiaExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Pain intensity during dental treatment (FLACC)

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).

Time frame
Immediately after completion of the dental procedures
2

Pain intensity during operative dental treatment (Wong-Baker)

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.

Time frame
Immediately after the dental procedures were completed

Secondary outcomes

Other outcomes

Sponsors and contacts

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