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Clinical Trials/CTRI/2025/07/091340
CTRI/2025/07/091340
Recruiting
Not Applicable

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 site in 1 country34 target enrollmentStarted: August 1, 2025Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
Dr Rusheta Baburaj
Enrollment
34
Locations
1
Primary Endpoint
Visual Analog Scale

Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 30.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Visual Analog Scale

Time Frame: 1 week, 1 month

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Dr Rusheta Baburaj
Sponsor Class
Other [self-sponsored]
Responsible Party
Principal Investigator
Principal Investigator

Rusheta Baburaj

Nair Hospital Dental College

Study Sites (1)

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