CTRI Number |
CTRI/2018/01/011352 [Registered on: 16/01/2018] Trial Registered Retrospectively |
Last Modified On: |
11/01/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia Dentistry |
Study Design |
Randomized, Crossover Trial |
Public Title of Study
|
A clinical study to compare the effect of 0.074% Diclofenac sodium mouthwash and 50 mg diclofenac sodium tablet in reduction of pain and swelling after gum surgery for pyorrhea. |
Scientific Title of Study
|
A randomized prospective split-mouth clinical study to compare the post-operative analgesic and anti-inflammatory effect of diclofenac sodium (0.074% mouthwash or 50mg tablets) after periodontal flap surgery. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Shreeprasad V Wagle |
Designation |
Post graduate student |
Affiliation |
MGVs KBH Dental College and Hospital |
Address |
Room number 202, Department of Periodontology and Implantology, MGVs KBH Dental College and Hospital, Panchavati, Nashik Panchavati, Nashik Nashik MAHARASHTRA 422003 India |
Phone |
8308068269 |
Fax |
|
Email |
svw1593@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Amit Agrawal |
Designation |
Post graduate Guide |
Affiliation |
MGVs KBH Dental College and Hospital |
Address |
MGVs KBH Dental College and Hospital, Panchavati, Nashik Panchavati, Nashik Nashik MAHARASHTRA 422003 India |
Phone |
9822107562 |
Fax |
|
Email |
agrodent@rediffmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Shreeprasad V Wagle |
Designation |
Post graduate student |
Affiliation |
MGVs KBH Dental College and Hospital |
Address |
MGVs KBH Dental College and Hospital, Panchavati, Nashik Panchavati, Nashik Nashik MAHARASHTRA 422003 India |
Phone |
8308068269 |
Fax |
|
Email |
svw1593@gmail.com |
|
Source of Monetary or Material Support
|
Department of periodontology and implantology MGVs KBH dental college and Hospital Nashik |
|
Primary Sponsor
|
Name |
None |
Address |
None |
Type of Sponsor |
Other [] |
|
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 Shreeprasad V Wagle |
MGVs KBH Dental College |
Room Number 202, Department of Periodontology and Implantology, MGVs KBH Dental college and Hospital, Panchavati, Nashik Nashik MAHARASHTRA |
8308068269
svw1593@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee Mahatma Gandhi Vidyamandir KBH Dental College and Hospital Nashik |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Patients indicated for conventional periodontal flap surgery, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Diclofenac Sodium 0.074% mouthwash |
After periodontal flap surgery either 0.074% diclofenac sodium mouthwash will be given or 50 mg tablet of same drug will be given. And analgesic and anti-inflammatory effect will be checked. |
Comparator Agent |
Diclofenac Sodium 50 mg tablet |
After periodontal flap surgery either 0.074% diclofenac sodium mouthwash will be given or 50 mg tablet of same drug will be given. And analgesic and anti-inflammatory effect will be checked. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
1. Patients having periodontal pocket depth ranging from 5mm to 8mm.
2. Patients indicated for periodontal surgery bilaterally in same arch.
3. Systemically healthy patients.
|
|
ExclusionCriteria |
Details |
1. Patients having endo-perio lesions.
2. Patients requiring resective osseous surgery or regenerative osseous surgery.
3. Patients with the history of intolerance or hypersensitivity to diclofenac.
4. Any systemic diseases or condition that affects the oral tissues,
5. Pregnant or lactating women.
6. Acute gingival or periodontal disease.
7. Patients on oral/systemic NSAIDs therapy for the last three months.
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Alternation |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Diclofenac sodium local application (0.074% mouthwash) will have equal analgesic effect as compared to its systemic administration (tablet), but it would be better in terms of its anti-inflammatory effect and patient’s acceptability when used after periodontal flap surgery. |
Analgesic effect will checked on 1st 2nd 3rd and 4th day after surgery. Inflammation will be assessed after 7 days 1 month and 3 months after surgery. |
|
Secondary Outcome
|
Outcome |
TimePoints |
None |
None |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
28/11/2017 |
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
|
Not published |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
All the patients will be
screened for periodontal findings. Sites meeting the inclusion criteria will be considered for the present study.
This study is designed as randomized prospective split-mouth clinical trial.
In test group patients will be given
0.074% diclofenac sodium mouthwash to be used at home for four days. Patients
in this group need to use the mouthwash for 1 min, twice daily for 4 days,
starting one immediately after surgery. Test group patients will also
prescribed diclofenac sodium 50mg tablet to be used if pain is not controlled
by diclofenac mouthwash alone. Number of tablets used by the patient (if any)
will also be recorded on their proforma sheet. In control group, patient will
be prescribed diclofenac sodium 50mg tablet twice daily for 4 days starting
immediately after surgery.
Randomization
with regard to the choice of quadrant and choice of drug formulation (mouthwash
or tablet) will be done by coin toss method. At least 15 days gap will be
maintained for second surgery in contralateral side when mode of therapy will
be switched.
Clinical
parameters will be checked at baseline, 7 days after surgery 1 month and 3
months after surgery. Pain perception of patient will be scored using Numerical
Rating Scale. Data will be collected telephonically in the evening daily for 4
days. Along with that patient will be given ‘Wong Baker scale’ score sheet too
and will be asked to fill it in the evening daily for 4 days. No perio dressing
will be placed after surgery in either group. At 7 days follow-up patient will
be asked about the acceptability of the mouthwash. At last follow-up of second
surgery, patient will be asked about their personal preference between
mouthwash and tablet for pain reduction. We hypothesize that diclofenac
sodium local application (0.074% mouthwash) will have equal analgesic effect as
compared to its systemic administration (tablet), but it would be better in
terms of its anti-inflammatory effect and patient’s acceptability when used
after periodontal flap surgery. |