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临床试验/NCT07326241
NCT07326241尚未招募不适用

Effects of Silver Diamine Fluoride and Intraoral Cryotherapy on Local Anesthesia Efficacy in Permanent Molars With Molar-Incisor Hypomineralization

Çanakkale Onsekiz Mart University2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2026年2月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
75
试验地点
2
主要终点
Pain intensity during dental treatment (FLACC)

研究概览

简要总结

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.

详细描述

The porous enamel structure of MIH-affected teeth facilitates bacterial penetration into enamel and dentin, which may lead to subclinical inflammatory reactions within the dentin-pulp complex. This inflammatory status has been associated with reduced effectiveness of local anesthesia during restorative dental procedures. In pediatric patients, difficulty in achieving adequate anesthesia may result in increased discomfort during treatment, contributing to dental anxiety, negative behavioral responses, and the need for repeated treatment sessions. Therefore, improving anesthetic efficacy in MIH-affected teeth is essential for both patient comfort and treatment quality.

Cryotherapy is a well-established method for pain management in medical practice. Its analgesic effect is attributed to reduced local inflammation, decreased nerve conduction velocity, and minimization of edema and bleeding. Previous studies have demonstrated that the use of cryotherapy following mandibular block anesthesia may reduce pain perception during dental treatment compared to conventional anesthesia alone.

Silver diamine fluoride (SDF) is a solution containing silver and fluoride ions that has been shown to effectively reduce dentin hypersensitivity by occluding dentinal tubules, promoting remineralization of demineralized tooth structure, and exerting antibacterial effects. SDF stabilizes active carious lesions and reduces sensitivity through the formation of fluorohydroxyapatite and tubule blockage. It was approved by the U.S. Food and Drug Administration in 2014 for the treatment of dentin hypersensitivity. Given its desensitizing properties, SDF may be a promising adjunctive approach to enhance anesthetic effectiveness in MIH-affected molars.

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 permanent first molars affected by MIH. Pediatric patients presenting for examination and treatment at the Department of Pediatric Dentistry will be allocated into three groups: a control group, a cryotherapy group, and an SDF group. Prior to treatment, demographic and dental characteristics will be recorded, and baseline pulp sensibility responses will be assessed using electric cold testing and air stimulation (SCASS).

All treated teeth will receive local anesthesia using a standardized mandibular block technique. In the SDF group, SDF will be applied prior to anesthetic administration. In the cryotherapy group, cold application will be performed on the buccal mucosa for 5 minutes using frozen saline contained in 2-mL dental syringes wrapped in sterile gauze before treatment. Following local anesthesia, caries removal and final composite resin restorations will be completed. Pain intensity and behavioral responses during treatment will be assessed using validated pediatric pain scales. The total duration of the clinical procedure is planned to be approximately 45 minutes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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
  • 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.

排除标准

  • 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.

结局指标

主要结局

Pain intensity during dental treatment (FLACC)

时间窗: 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)

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Çanakkale Onsekiz Mart University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Burak Carıkcıoglu

Associate Professor

Çanakkale Onsekiz Mart University

研究点 (2)

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