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

NCT07326241 | Not Yet Recruiting

• 1 other identifier: CanakkaleOMU4
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

MIH; Caries Assessment; Molar-Incisor Hypomineralization

Outcome Measures

Primary Outcomes (2)

• 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).

  Immediately after completion of the dental procedures

• 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.

  Immediately after the dental procedures were completed

Study Arms (3)

Control (Standard Local Anesthesia)

ACTIVE COMPARATOR

Standard local anesthesia and operative restorative treatment only (no adjunctive SDF or cryotherapy).

Other: Standard Local Anesthesia

Intraoral Cryotherapy + Standard Local Anesthesia

EXPERIMENTAL

Intraoral cryotherapy applied before anesthesia, followed by standard local anesthesia and operative restorative treatment.

Other: Standard Local Anesthesia; Other: Intraoral Cryotherapy

Silver Diamine Fluoride (SDF) + Standard Local Anesthesia

EXPERIMENTAL

Silver diamine fluoride applied before anesthesia, followed by standard local anesthesia and operative restorative treatment.

Other: Standard Local Anesthesia; Other: Silver Diamine Fluoride (SDF)

Interventions

Standard Local Anesthesia OTHER

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

Control (Standard Local Anesthesia); Intraoral Cryotherapy + Standard Local Anesthesia; Silver Diamine Fluoride (SDF) + Standard Local Anesthesia

Intraoral Cryotherapy OTHER

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

Intraoral Cryotherapy + Standard Local Anesthesia

Silver Diamine Fluoride (SDF) OTHER

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

Silver Diamine Fluoride (SDF) + Standard Local Anesthesia

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Çanakkale Onsekiz Mart University: lead
• Mersin University: collaborator

Study Sites (2)

Çanakkale Onsekiz Mart University, School of Dentistry

Çanakkale, Turkey (Türkiye)

Location

Mersin University, School of Dentistry

Mersin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Molar Hypomineralization

Interventions

silver diamine fluoride

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Burak Çarıkçıoğlu, Associate Professor

  Çanakkale Onsekiz Mart University

  PRINCIPAL INVESTIGATOR

• Seçkin Aksu, Assistant Professor

  Mersin University

  STUDY DIRECTOR

• Hilal Öztürk, Research Assistant

  Çanakkale Onsekiz Mart University

  STUDY CHAIR

Central Study Contacts

Burak Çarıkçıoğlu, Associate Professor

CONTACT

+905054956091; carikcioglub@gmail.com

Hilal Öztürk, Research Assistant

CONTACT

+905312591404; hilalozturk98@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 8, 2026
• Study Start: February 1, 2026
• Primary Completion: March 15, 2026
• Study Completion: April 1, 2026
• Last Updated: January 8, 2026

Record last verified: 2025-12

Locations

TU (2)