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临床试验/CTRI/2024/04/066002
CTRI/2024/04/066002已完成3 期

Efficacy of cryotherapy with local anesthesia in pain control during restoration of teeth with Molar Incisal Hypomineralisation - A Randomized Control Trial

Dr Faizal CP1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2024年5月2日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
54
试验地点
1
主要终点
a) Changes in VAS pain scale scores

研究概览

简要总结

INTRODUCTION: Molar Incisor hypomineralisation (MIH) is a prevalent dental condition that affects up to 25% of children worldwide. In general, enamel hypomineralization is caused by  disturbances in the function of ameloblast cells during any of the amelogenesis stages. MIH is believed to be due to multifactorial systemic factors that contribute to enamel hypomineralization. Its exact etiology remains uncertain.  Clinical management of young patients with MIH affected teeth becomes more challenging due to difficulty in achieving local anesthesia as there is  chronic sub clinical inflammation caused by ingress of bacteria in the exposed dentin, this causes an altered nerve potential. Inadequate anaesthsia leads to  limited cooperation for treatment  by the young children, thus affecting the quality of the restorations

RATIONALE OF THE STUDY: Studies have shown that cryotherapy application boosts the efficacy of pulpal anesthesia of the mandibular first permanent molars with Symptomatic Irreversible pulpitis . Therefore the efficacy of cryotherapy after Local administration is tested for pain control in patients with MIH

PROCEDURE  Group 1 (control): A standard IANB will be administered using 2.5 mL of 2% lidocaine with 1:200000 adrenaline . The block will be administered with a 24-Gauge, 25-mm needle (Dispovan) inserted and IANB will be given. Group 2 (IANB+ Endo frost spray cryotherapy): A standard IANB will be administered in the same way as in the control group, then endo-frost will be applied on the buccal, lingual (3 seconds/surface), and occlusal surfaces (4 seconds) for a total of 10seconds.

The restorative procedure in both the groups will begin 10minutes after the IANB when the patient has lip numbness. Standardization of the protocol will be done by choosing the same operator, material, technique, and clinical settings. The tooth will be isolated using a rubber dam

EVALUATION During the restorative procedure, a subjective and an observational scale is used to record the pain . Wong-Baker FPR scale  : the patients will be instructed to report their pain again on a scale. A set of six cartoon faces were shown to the child with varying facial expressions ranging from a very smiling face to a very sad face.

FLACC scale (Face, Legs, Activity, Cry, Consolability)  is recorded by an blinded observer.. The scale has five criteria, which are each assigned a score of 0, 1 or 2 Total scores are added from each criterion   EXPECTED OUTCOME: Null hypothesis: There will be no difference in pain between local anesthesia (traditional inferior alveolar nerve block) with cryotherapy and local anesthesia (traditional inferior alveolar nerve block) during restoration of MIH affected first Permanent mandibular Molar in children.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
8.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • healthy children with enamel/dentin breakdown due to MIH aged 8–12 years requiring restorative treatment for Molar Incisor Hypomineralisation .(based on MIH TNI criteria 4 ) in first molars bilaterally.

排除标准

  • children with systemic diseases and dental history of irreversible pulpitis, abscess, sinus tract, or fistula of first lower molars.

结局指标

主要结局

a) Changes in VAS pain scale scores

时间窗: 10 minutes after local anaesthesia is administered, pain scores will be taken at the time of cavity preparation

b) Changes in FLACC pain scale scores

时间窗: 10 minutes after local anaesthesia is administered, pain scores will be taken at the time of cavity preparation

次要结局

  • a) Need for further management with local anesthetics.(b) Need for medications postoperatively)

研究者

发起方
Dr Faizal CP
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Faizal CP

Kannur Dental College

研究点 (1)

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