FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/091340 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 20/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study on Comparison of chewing gum and paracetamol tablet in pain management of adult patients undergoing expansion therapy by removable orthodontic appliances 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rusheta Baburaj 
Designation  Postgraduate Student 
Affiliation  Nair Hospital Dental College 
Address  Room no 402, Department of Orthodontics, Nair Hospital Dental College, Mumbai.

Mumbai
MAHARASHTRA
400008
India 
Phone  9220152486  
Fax    
Email  rushetaparvathi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Naval Bawaskar 
Designation  Associate Professor 
Affiliation  Maharashtra University of Health Sciences, Nashik 
Address  Room no 402, Department of Orthodontics, Nair Hospital Dental College, Mumbai.

Mumbai
MAHARASHTRA
400008
India 
Phone  9004008555  
Fax    
Email  navalbawaskar@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Rusheta Baburaj 
Designation  Postgraduate Student 
Affiliation  Nair Hospital Dental College 
Address  Room no 402, Department of Orthodontics, Nair Hospital Dental College, Mumbai.


MAHARASHTRA
400008
India 
Phone  9220152486  
Fax    
Email  rushetaparvathi@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Dr Rusheta Baburaj 
Address  Room no 402, Dept of Orthodontics, Nair Hospital Dental College, Mumbai- 400008. 
Type of Sponsor  Other [Self-sponsored] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rusheta Baburaj  Nair Hospital Dental College  Room no 402, Dept of Orthodontics, Nair Hospital Dental College, Mumbai.
Mumbai
MAHARASHTRA 
9220152486

rushetaparvathi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Nair Hospital Dental College Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Paracetamol Tablet 500 mg  Plain paracetamol tablets of 500 mg dosage once a day after activation of the appliance and after 28 days once a day when patient reports for activation recall 
Intervention  Xylitol Chewing Gum  Color changing, sugar free, xylitol based chewing gum to be given immediately after activation of the appliance for 10 minutes and after 28 days when patient reports for actvation recall 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1) 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
 
 
ExclusionCriteria 
Details  1) 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.
5) Smokers.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Visual Analog Scale  1 week, 1 month 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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

 
Close