跳至主要内容
临床试验/CTRI/2025/07/091340
CTRI/2025/07/091340招募中不适用

Comparative Clinical Evaluation of effectiveness of Xylitol Gum with Paracetamol 500mg in Pain Management of Patients undergoing Orthodontic treatment with Removable Expansion Appliances: A Prospective Cohort Study

Dr Rusheta Baburaj1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
34
试验地点
1
主要终点
Visual Analog Scale

研究概览

简要总结

Introduction

Orthodontic appliances in the form of a fixed or removable therapy involve certain underlying biologic mechanisms creating sites of inflammation These sites cause pain which starts about 4 hours after activation of the appliance peaks between 12 hours and 3 days after insertion and lasts for upto 7 days

Clinicians usually employ the use of NSAIDs and acetaminophen(Paracetamol), that is considered as the most successful modality in reducing pain resulting from orthodontic appliances They are easily available as an over-the-counter drug, use of which has long term side effects such as Gastric Irritation Hypertension Liver Toxicity

Non-Pharmacological methods can prove to be a suitable alternative to avoid these systemic effects. It has been shown that the act of chewing leads to increased pulpal sensory thresholds to electrical stimulation. Chewing has been recommended as a means of increasing the blood flow into and around the periodontal membrane restoring lymphatic circulation and preventing or relieving the inflammation and hence pain

Chewing gum is a non-invasive effective convenient and inexpensive way to relieve orthodontic pain.

Aims and Objective:

To evaluate and compare the efficacy of Chewing gum as a non-pharmacological alternative to 500mg Paracetamol in the management of pain in patients undergoing Removable Orthodontic Expansion Appliance therapy

Methodology:

The patients fitting in the inclusion criteria will be divided into two groups using Computer assisted randomization – Group A and Group B

Following initial examination and treatment planning, the subjects will be divided into Groups A and B. The baseline levels of pain will be noted using VAS with the initial activation of Removable appliance at 7-day recall and 28-day recall.

The following type of Removable appliance will be considered-

• Transverse Expansion appliance with Jackscrew.

Group A(n=34) [STUDY GROUP]:

A Sugar free non- sticky chewing gum (Lotte XYLITOL chewing check gum) will be given. This gum contains citric acid, which maintains the green colour of the gum. On chewing, the acid dissolves, exposing the dye to the oral environment. This changes it to a red colour, that is released when the salivary pH turns neutral to alkaline. This indicates that the gum has been chewed effectively

Group B: (n=34) [CONTROL GROUP]

Paracetamol 500mg Tablet will be given half an hour before the initial activation of the removable appliance at 7-day recall. The next pain recording will be at 28-day recall

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • patients subjected to treatment by a removable orthodontic expansion appliance 2) Subjects having a Bilateral Class I Molar Relation/stable occlusal relation with mild(0-1.5mm) to moderate (1.5 – 2 mm) anterior crowding 3) Medically fit 4) Patient willing to give the informed consent and willing to comply with the study will be selected.

排除标准

  • Allergy/Hypersensitivity to acrylic or nickel and Paracetamol 2) Pain due to extraction or surgical procedures advised for orthodontic treatment 3) Pain due to ulceration on application of Removable appliances 4) Pregnant or lactating patients.

结局指标

主要结局

Visual Analog Scale

时间窗: 1 week, 1 month

次要结局

未报告次要终点

研究者

发起方
Dr Rusheta Baburaj
申办方类型
Other [self-sponsored]
责任方
Principal Investigator
主要研究者

Rusheta Baburaj

Nair Hospital Dental College

研究点 (1)

Loading locations...

相似试验