| CTRI Number |
CTRI/2023/06/054276 [Registered on: 21/06/2023] Trial Registered Prospectively |
| Last Modified On: |
16/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Medical Device Surgical/Anesthesia Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of three different methods in Surgical extractions of partially erupted
Mandibular Third Molars using Piezo-Surgery and Piezo-surgery with steroid injections or rubber drain. |
|
Scientific Title of Study
|
Comparative Evaluation of Post-operative Outcomes following Surgical removal of Impacted
Mandibular Third Molars using Piezo Surgery, Piezo Surgery with Submucosal Dexamethasone
and Piezo Surgery with Surgical Drain. A Prospective Clinical 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 Prathamesh Moreshwar Dhore |
| Designation |
PG student |
| Affiliation |
MGM Dental College and Hospital |
| Address |
MGM Dental College and Hospital, Kamothe, 4th floor, Department of Oral and Maxillofacial Surgery, Plot no. 1 and 2, Sector 01 (old 18 and 19), Kamothe, Navi Mumbai. Pin-410209. Raigarh
Raigarh MAHARASHTRA 410209 India |
| Phone |
7276475361 |
| Fax |
|
| Email |
prathamesh.dhore@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Srivalli Natrajan |
| Designation |
Professor and HOD |
| Affiliation |
Professor and HOD under OMFS |
| Address |
MGM Dental College and Hospital, Kamothe, 4th floor, Department of Oral and Maxillofacial Surgery, Plot no. 1 and 2, Sector 01 (old 18 and 19), Kamothe, Navi Mumbai. Pin-410209. Raigarh
Raigarh MAHARASHTRA 410209 India |
| Phone |
9769088803 |
| Fax |
|
| Email |
srivalli.shrikanth@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Adil Gandevivala |
| Designation |
Professor and Guide |
| Affiliation |
Reader under OMFS |
| Address |
MGM Dental College and Hospital, Kamothe, 4th floor, Department of Oral and Maxillofacial Surgery, Plot no. 1 and 2, Sector 01 (old 18 and 19), Kamothe, Navi Mumbai. Pin-410209. Raigarh
Raigarh MAHARASHTRA 410209 India |
| Phone |
9096815606 |
| Fax |
|
| Email |
dr.adilg@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Dental College and Hospital, Kamothe, 4th floor, Department of Oral and Maxillofacial Surgery, Plot no. 1 and 2, Sector 01 (old 18 and 19), Kamothe, Navi Mumbai. Pin-410209. Raigarh |
|
|
Primary Sponsor
|
| Name |
MGM Dental College and Hospital |
| Address |
MGM Dental College and Hospital, Kamothe, 4th floor, Department of Oral and Maxillofacial Surgery, Plot no. 1 and 2, Sector 01 (old 18 and 19), Kamothe, Navi Mumbai. Pin-410209. Raigarh |
| Type of Sponsor |
Private medical college |
|
|
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 Prathamesh Dhore |
MGM Dental College and Hospital |
MGM Dental College and Hospital, Kamothe, 4th floor, Department of Oral and Maxillofacial Surgery, Plot no. 1 and 2, Sector 01 (old 18 and 19), Kamothe, Navi Mumbai. Pin-410209. Raigarh Raigarh MAHARASHTRA |
7276475361
prathamesh.dhore@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MGM Dental College and Hospital |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K011||Impacted teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Submucosal Dexamethasone |
8 mg submucosal Dexamethasone will be administered intra operatively as a single dose |
| Intervention |
Surgical extraction with Piezo-surgery |
Surgical extraction of third molar will be done using piezo-surgery and post operative sequelae will be noted. |
| Comparator Agent |
Surgical extraction with piezo-surgery with surgical drain |
Surgical extraction of third molar will be done using piezo-surgery with surgical drain and post operative sequelae will be noted. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Impacted mandibular third molars with Pederson’s difficulty score between 5 to 7.
Male and female participants in the age group of 18-45 years.
Participants willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Patients with known allergies to local anaesthetics, antibiotics and analgesics.
Pregnancy and lactation.
Systemic diseases
Bone metabolism disorder.
Signs of active infection and inflammation. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the post operative swelling with the use of Piezo-surgery, Piezo-surgery with submucosal dexamethasone, Piezo-surgery with surgical drain after the extraction of impacted mandibular third molars. |
Post operatively follow up will be done at 1st, 3rd and 7th day.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the post operative pain with the use of Piezo-surgery, Piezo-surgery with submucosal dexamethasone, Piezo-surgery with surgical drain after the extraction of impacted mandibular third molars. |
Post operatively follow up will be done at 1st, 3rd and 7th day.
|
|
|
Target Sample Size
|
Total Sample Size="75" Sample Size from India="75"
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 4 |
|
Date of First Enrollment (India)
|
16/07/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Surgical extraction of the impacted third molar is one of the most performed surgical procedures in the field of Oral and Maxillofacial Surgery. Assessment of third molars surgery in terms of indications, surgical techniques, symptoms, and postoperative sequelae becomes a necessity to offer patients high quality care and minimize their suffering. One of the most important steps in mandibular third molar surgery is the removal of the covering bone or osteotomy, for which many techniques are used. The most recent technique includes the use of Piezo-surgery. The piezoelectric instrument produces a modulated ultrasonic frequency of 24–29 kHz and a microvibration amplitude between 60 and 200 mm/s. The amplitude of these microvibrations allows a clean, precise cut. Piezoelectric surgery is very efficient for osteotomy because it works selectively—the soft tissues, including nerves and blood vessels, are unaffected. This represents a significant advantage over the use of a bur. In addition, the use of anti-inflammatory medications is the prevalent attitude to decrease postoperative complications. Corticosteroids are one of the most widely employed medications administered to control these complications. Dexamethasone is known to be more powerful than other anti-inflammatory drugs because of its extended duration of action. The rationale of this study is to see if there a difference in post operative sequelae using Piezo-surgery, Piezo-surgery with submucosal Dexamethasone, Piezo-surgery with surgical drain after the extraction of impacted mandibular third molars.
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