| 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
|
|
|
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
|
|
|
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
|
|
|
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
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