| CTRI Number |
CTRI/2024/11/076458 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
04/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing pain-killer coated stitches and plain stitches after removal of teeth for pain and healing. |
|
Scientific Title of Study
|
A comparative assessment between analgesic and non analgesic coated suture material in evaluation of post extraction pain and healing : A prospective split mouth 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 |
Dr Deeyah Miriam Deepak |
| Designation |
Post Graduate |
| Affiliation |
Yenepoya Dental College |
| Address |
Room number -4
Dept of Oral and Maxillofacial Surgery,
1st floor,
Yenepoya Dental College,
Yenepoya University,
Deralakatte,
Mangalore
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
7996377624 |
| Fax |
|
| Email |
deeyahmiriamdeepak@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Jagadish Chandra |
| Designation |
Head of The Department |
| Affiliation |
Yenepoya Dental College |
| Address |
Room number -4
Dept of Oral and Maxillofacial Surgery
1st floor,
Yenepoya Dental College,
Yenepoya University
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
9845150871 |
| Fax |
|
| Email |
jagadishmds@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Deeyah Miriam Deepak |
| Designation |
Post Graduate |
| Affiliation |
Yenepoya Dental College |
| Address |
Room number -4
Dept of Oral and Maxillofacial Surgery
1st floor,
Yenepoya Dental College,
Yenepoya University
KARNATAKA 575018 India |
| Phone |
7996377624 |
| Fax |
|
| Email |
deeyahmiriamdeepak@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya Dental College,
University Road Deralakatte Mangalore 575018 |
|
|
Primary Sponsor
|
| Name |
Dr. Deeyah Miriam Deepak |
| Address |
Marian Aspire
Flat no 201
Daddalkad 575006 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Deeyah Miriam Deepak |
Yenepoya Dental College |
Room number -4
Dept of Oral and Maxillofacial Surgery
1st floor,
Yenepoya Dental College,
Yenepoya University Dakshina Kannada KARNATAKA |
7996377624
deeyahmiriamdeepak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee-1, Yenepoya (Deemed to be University) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients who are reporting to the Department of oral surgery, Yenepoya dental college for bilateral symmetrical extractions. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Plain vicyrl 3-0 |
Participants who fit the inclusion and exclusion criteria after screening and after due process of informed consent will be randomised to this group (Group B) and will receive standard of care and in addition suturing of wound will be done with the interventional product (Plain Vicyrl 3–0 ) Follow up will happen after 7 days, 14 days. |
| Intervention |
Vicyrl 3-0 soaked in ketorolac |
Participants who fit the inclusion and exclusion criteria after screening and after due process of informed consent will be randomised to this group (Group A) and will receive standard of care and in addition suturing of wound will be done with the interventional product (Vicyrl 3–0 soaked in ketorolac) Follow up will happen after 7 days, 14 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients within the age of 18 – 60 years.
2.Patients with any bilateral symmetrical extractions.
3.Patients who are medically fit for the procedure. |
|
| ExclusionCriteria |
| Details |
1. Patients who are not willing to participate in the study.
2. Pregnant or lactating mothers.
3.Patients with immunocompromised conditions and systemic diseases.
4.Clinical evidence of acute infection, inflammation or any other pathologies like periapical cyst, tumours, fractures etc. around the tooth to be extracted for the study.
5.Patients who are allergic to the analgesic drug. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess pain and healing in post extraction 1 day, 3 days and 7 days. |
To assess pain and healing in post extraction 1 day, 3 days and 7 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess better quality of life in these patients by fore-said parameters |
Follow up of 7 days |
|
|
Target Sample Size
|
Total Sample Size="18" Sample Size from India="18"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/11/2024 |
| Date of Study Completion (India) |
30/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Wound repair is a well orchestrated and highly coordinated process. Sutures serve to maintain tissue approximation until the wound attains sufficient tensional strength to prevent dehiscence. Correct closure and stabilization of surgical wound margins influence the success of the surgical procedure. The number of tissue layers involved in wound closure, the amount of tension across the sutured wound, the depth at which the suture is placed, the presence of edema, the approximate amount of time the suture must be kept in place, and the inflammatory reactions displayed by the suture material are some of the factors that influence the choice of suture material in the management of surgical wounds. Post extraction pain has often been a nemesis for dental surgeons,with clinicians perpetually striving for an analgesic modality that would provide profound analgesia and would be best tolerated by the patient, hence ensuring patient compliance. Medications such as NSAIDS are frequently provided to patients experiencing post-surgical pain and are to be taken orally or parentarally.Long term repeated medication administrations are necessary as long term pain lasts until the wounds have nearly healed. Gastrointestinal disturbances, Electrolytic imbalance, Fluid retention hypertension, Hyperkalemia, Hyponatremia, Reye’s syndrome, Platelet dysfunction and Renal impairment are just a few of the side effects. Since oral medications must first pass through the liver for metabolism, there will be less bioavailability and due to high plasma concentration which leads to significant adverse effects, local drug delivery is advantageous for reducing pain at the surgical site. Ketorolac tromethamine is a pyrrolo -pyrrole non steroidal anti inflammatory drug with potent analgesic, anti inflammatory and antipyretic activity. Mechanism of action of Ketorolac is by inhibiting the cycloxygenase pathway of arachidonic acid metabolism, resulting in a decrease in prostaglandin and thromboxane production. Therefore, Analgesic-coated suture can be used as a medical aid potentially suitable for local drug delivery to treat post-surgical pain. In this study, we will be comparing Analgesic coated suture- Ketorolac tromethamine and Non Analgesic coated suture Vicryl 3-0 post extraction to provide local drug delivery to alleviate pain and assess healing in patients by two interventions.
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