| CTRI Number |
CTRI/2024/12/077989 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to compare the efficacy of diclofenac oral rinse versus diclofenac tablet versus chewing gum in management of orthodontic pain |
|
Scientific Title of Study
|
Comparative assessment of analgesic (Topical and systemic) and chewing gum in the management of orthodontic pain: A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr sarfaraz akhtar |
| Designation |
MDS 1st year |
| Affiliation |
darshan dental college and hospital |
| Address |
Department of orthodontics and dentofacial orthopedics,
Darshan dental college and hospital,
Ranakpur road, Loyara,
Udaipur
Udaipur RAJASTHAN 313011 India |
| Phone |
08003752127 |
| Fax |
|
| Email |
sarfaraz.akh@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Trivedi rutvik |
| Designation |
Reader |
| Affiliation |
darshan dental college and hospital |
| Address |
Darshan dental college and hospital,
Ranakpur road, Loyara,
Udaipur, rajasthan.
313011 House No 10, 60 feet Venice Apartment Road, Meeranagar B block, Bhuwana, Udaipur, rajasthan.
313001. Udaipur RAJASTHAN 313011 India |
| Phone |
08003752127 |
| Fax |
|
| Email |
dr.rutviktrivedi@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr sarfaraz akhtar |
| Designation |
MDS 1st year |
| Affiliation |
darshan dental college and hospital |
| Address |
Department of orthodontics and dentofacial orthopedics,
Darshan dental college and hospital,
Ranakpur road, Loyara,
Udaipur
Udaipur RAJASTHAN 313011 India |
| Phone |
08003752127 |
| Fax |
|
| Email |
sarfaraz.akh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Darshan dental college and hospital, loyara, udaipur, rajasthan. 313011 |
|
|
Primary Sponsor
|
| Name |
Dr sarfaraz akhtar |
| Address |
Room no.210, Pratap boys hostel,
darshan dental college and hospital,
Ranakpur road, Loyara,
Udaipur, rajasthan. 313011 |
| Type of Sponsor |
Other [Self] |
|
|
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 Sarfaraz akhtar |
Darshan dental college and hospital |
Department of orthodontics and dentofacial orthopedics (no.8), second floor, Darshan dental college and hospital, loyara, udaipur,rajasthan.
313011
Udaipur RAJASTHAN |
08003752127
sarfaraz.akh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, Sai Tirupati University, Udaipur (Rajasthan), India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M263||Anomalies of tooth position of fully erupted tooth or teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chewing Gum |
xylitol chewing gum
(sugar free and non sticky)
Patients have to take the chewing gum 4 times a day. |
| Comparator Agent |
Control group |
Patient will not be provided with any pain treatment modalities after archwire placement. Patients will put the values of pain on visual analog scale.
|
| Intervention |
Diclofenac mouth wash |
Diclofenac oral rinse 0.074%
10ml per use, thrice a day
For 3 days.
Topical route of administration |
| Comparator Agent |
Tab. Diclofenac |
Tab. Diclofenac 100mg
once a day for 3 days will be given to patients.
Oral route of administration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
32.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with mild to moderate Crowding
2. Patients within age group 18-32 years
3. No previous Orthodontic treatment history |
|
| ExclusionCriteria |
| Details |
1. Patients with active periodontal diseases
2. Allergic to diclofenac
3. Autoimmune disease
4. Pregnant and lactating Women
5. Cardiovascular disease
6. History of gastritis or peptic ulcer |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| topical analgesic form is similarly potent as compared to its systemic analgesic form in management of orthodontic pain. |
baseline (2 hours after initial wire placement), upto 4 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Analgesic oral rinse and xylitol chewing gum can be an efficient modality in orthodontic pain management as well as more convenient to the patints. |
baseline (2 hours after initial wire placement), upto 4 days |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/12/2024 |
| 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) |
Not Yet Recruiting |
|
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
|
Pain is a subjective response showing large individual variations, when arising from orthodontic force application is a major concern for patients, parents and clinicians. Diclofenac is a potent anti-inflammatory drug that is well suited for local use in the oral cavity. The drug results in decreased production of Prostaglandins hence, reduce inflammation or swelling and pain. “It is hypothesized that diclofenac oral rinse would be a better alternative to its systemic administration, in terms of patient acceptance"
There are several other non-pharmacological methods for orthodontic pain relief and masticatory stimulation of the periodontal ligament such as the chewing of gum or use of bite wafers has been reported to alleviate pain induced by the application of orthodontic force. Chewing rubbery materials allows blood flow in compressed areas of the periodontal ligament and prevents the formation of pain-inducing inflammatory metabolites, thereby attenuating pain perception. Hence, this study is planned to assess and compare the efficacy of diclofenac (local and systemic form-oral route) and chewing gum (non sticky and sugar free) with control group in the management of orthodontic pain Procedure of conduction of research: - The participants will be evaluated on the basis of mild to moderate crowding followed by the inclusion criteria. Randomized allotment will be done in the four groups respectively. A 0.014†Cu NiTi wire will be placed in patient’s mouth after bonding is done with conventional metal brackets. Pain relief remedies will be provided as per group allotments with a questionnaire which will be collected in the next appointment and instruction will be given. The filling of questionnaire on proper time will be assessed through telephonic reminders. Predesigned pain questionnaire including visual analog scale will be given to the patients and will be collected in the next appointment.
|