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

NCT07326241 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-01-08

No results posted yet for this 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.

Conditions

  • MIH
  • Molar-Incisor Hypomineralization
  • Caries Assessment

Interventions

OTHER

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

OTHER

Intraoral Cryotherapy

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

OTHER

Silver Diamine Fluoride (SDF)

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

Sponsors & Collaborators

  • Mersin University

    collaborator OTHER

  • Çanakkale Onsekiz Mart University

    lead OTHER

Principal Investigators

  • Burak Çarıkçıoğlu, Associate Professor · Çanakkale Onsekiz Mart University

  • Seçkin Aksu, Assistant Professor · Mersin University

  • Hilal Öztürk, Research Assistant · Çanakkale Onsekiz Mart University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2026-03-15
Completion
2026-04-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07326241 on ClinicalTrials.gov