| CTRI Number |
CTRI/2020/03/024296 [Registered on: 27/03/2020] Trial Registered Prospectively |
| Last Modified On: |
30/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
EFFICACY OF ORAL ANALGESIC PREPARATIONS ON PAIN INTENSITY AFTER TOOTH EXTRACTION |
|
Scientific Title of Study
|
COMPARATIVE EFFICACY OF ORAL ANALGESIC PREPARATIONS ON PAIN INTENSITY AFTER ORTHODONTIC EXTRACTION: A PRELIMINARY STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swapnil Shinde |
| Designation |
Assistant Professor |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, |
| Address |
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital,
Department of Oral Surgery, Wanlesswadi, Sangli - Miraj Raod
Sangli
MAHARASHTRA
416416
India |
| Phone |
07045653288 |
| Fax |
|
| Email |
drswapnilshinde1818@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Khairnar |
| Designation |
Assistant Professor |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, |
| Address |
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital,
Department of Public Health Dentistry, Wanlesswadi, Sangli - Miraj Raod
Wanlesswadi, Sangli - Miraj Raod
Sangli
MAHARASHTRA
416416
India |
| Phone |
07045653288 |
| Fax |
|
| Email |
kmahesh222@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh Khairnar |
| Designation |
Assistant Professor |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, |
| Address |
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital,
Department of Public Health Dentistry, Wanlesswadi, Sangli - Miraj Raod
Wanlesswadi, Sangli - Miraj Raod
Sangli
MAHARASHTRA
416416
India |
| Phone |
07045653288 |
| Fax |
|
| Email |
kmahesh222@gmail.com |
|
|
Source of Monetary or Material Support
|
| MILIND CHEMICALS AND MARKETING CORPORATION |
|
|
Primary Sponsor
|
| Name |
Milind M Babar |
| Address |
MILIND CHEMICALS AND MARKETING CORPORATION,
Gothan Galli, Babarwada Miraj, District Sangli,
Pin 416410, Maharashtra, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Swapnil Shinde |
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital Sangli |
Bharati Vidyapeeth Deemed University Dental College and Hospital,
Department of Oral Surgery,
Wanlesswadi, Sangli,
Sangli
MAHARASHTRA |
02332211323
drswapnilshinde1818@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth (Deemed to be University) Medical College and Hospital Sangli |
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 |
Aceclofenac Tablet |
Aceclofenac is a member of phenyl acetic acid class of NSAIDs. It has an analgesic and anti-inflammatory properties.
Dose, frequency and route of administration:
100mg tablet, orally, three times a day, for three days |
| Intervention |
Analdet Tablet |
Analdent, herbal drug has been prepared at Bharti Vidyapeeth Pharmacy College, Kolhapur. It is first Indian herbal preparation used as an analgesic, anti-inflammatory and antimicrobial effect having no side effects. Preclinical and clinical trials of this formulations were conducted at Bharati Vidyapeeth College of Pharmacy, Kolhapur and Tilak Ayurvedic Mahavidyala, Pune respectively. The product founds to be suitable for all ages of patients and no untoward results have been observed. It is safe for both GI tract and kidney.
Dose, frequency and route of administration:
400mg tablet orally, three times a day for three days |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient needed extraction of premolar tooth because of orthodontic reasons.
2. Age more than 13 years |
|
| ExclusionCriteria |
| Details |
1. Medically compromised patients. The patients with systemic comorbidity such as bleeding disorders, cardiovascular diseases, gastrointestinal lesions, diabetes mellitus, etc. will be excluded. 2. Patients having infection (systemic or dental) were not included. 3. Patient not willing for extraction. 4. Patient not willing for follow up post-operatively. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Measurement of Post-operative pain |
Post-operative pain at 8 Hours, 24 Hours, 48 Hours and 72 Hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post-operative swelling |
Post-operative swelling at 8 Hours, 24 Hours, 48 Hours and 72 Hours |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "22"
Final Enrollment numbers achieved (India)="22" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2020 |
| Date of Study Completion (India) |
20/04/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
J. Maxillofac. Oral Surg. (Jan–Mar 2023) 22(1):152–158 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Dental extraction is a common procedure in dental practice. The major concern after every extraction is postoperative pain and swelling. Hence the trial attempts to compare the efficacy between the two drugs in terms of alleviation of postoperative pain and facial swelling after extraction of tooth. |