| CTRI Number |
CTRI/2024/05/067285 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
13/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of corticosteroid injection before removal of tooth. |
|
Scientific Title of Study
|
Efficacy of submucosal and massetric methylprednisolone prior to impacted third molar surgery- 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 |
Priyanka Gajare |
| Designation |
Post graduate student |
| Affiliation |
Government Dental College and Hospital Mumbai |
| Address |
Department of Oral and Maxillofacial Surgery, Department no- 118, PD Mello road, CSMT Fort, Mumbai, 400001.
Mumbai
MAHARASHTRA
400001
India |
| Phone |
08692854835 |
| Fax |
|
| Email |
pgajare80@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kavita Wadde |
| Designation |
Head of Department of Oral and Maxillofacial Surgery and Guide |
| Affiliation |
Government Dental College and Hospital Mumbai |
| Address |
Department of Oral and Maxillofacial Surgery, Department no- 118, PD Mello road, CSMT Fort, Mumbai, 400001.
Mumbai
MAHARASHTRA
400001
India |
| Phone |
9004799405 |
| Fax |
|
| Email |
dr.kavitawadde@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Gajare |
| Designation |
Post graduate student |
| Affiliation |
Government Dental College and Hospital Mumbai |
| Address |
Department of Oral and Maxillofacial Surgery, Department no- 118, PD Mello road, CSMT Fort, Mumbai, 400001.
Mumbai
MAHARASHTRA
400001
India |
| Phone |
08692854835 |
| Fax |
|
| Email |
pgajare80@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital, PD Mello road, CSMT Fort, Mumbai, India, 400001. |
|
|
Primary Sponsor
|
| Name |
Priyanka Gajare |
| Address |
Government Dental College and Hospital, Department of Oral and Maxillofacial Surgery, Department -118, PD Mello road, CSMT Fort,Mumbai, 410210 |
| 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 Priyanka Gajare |
Government Dental College and Hospital Mumbai |
Department of Oral and Maxillofacial Surgery, Department no- 118, PD MellO road, CSMT Fort, Mumbai, 400001
Mumbai
MAHARASHTRA |
08692854835
pgajare80@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Dental College and Hospital Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K011||Impacted teeth, (2) ICD-10 Condition: K011||Impacted teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Massetric methylprednisolone injection |
Patients with impacted third molar with no medical comorbidities will be injected with methylprednisolone 40 mg/ml injection in massetric muscle extraorally one hour prior to surgery once before impacted third molar surgery. Total duration will be one year. |
| Intervention |
Submucosal methylprednisolone injection |
Patients with impacted third molar with no medical comorbidities will be injected with submucosal methylprednisolone 40 mg/ml injection intraorally one hour prior to surgery once before impacted third molar surgery.Total duration of the intervention will be one year. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are willing to participate in the study.
2. Healthy subjects (ASA Grade I and Grade II patients).
3. Patients in the age group of 21-40 years.
4. Patients with no contraindications to the drugs or anaesthetic used in the surgical protocol.
5. Patients with Moderate Difficulty index of impacted mandibular third molar as per Pederson Difficulty Index
|
|
| ExclusionCriteria |
| Details |
1. Patients not giving consent for participation in the study.
2. Immunocompromised patients.
3. Patients who are contraindicated to corticosteroids.
4. Diabetic patients
5. Pregnant or lactating patients.
6. Mentally challenged patients, those with severe systemic conditions, bone infections, osteomyelitis or osteoradionecrosis of jaw, any malignancy, cyst or tumor associated with the third molar.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain, swelling, trismus and evaluation of post operative complications and quality of life |
1 day, 4 days, 1 week, 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
24/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/05/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
EFFICACY OF SUBMUCOSAL AND MASSETRIC METHYLPREDNISOLONE PRIOR TO IMPACTED THIRD MOLAR SURGERY- A RANDOMIZED CONTROLLED TRIAL. William stated impacted tooth as one which is completely or partially unerupted and is positioned against another tooth, bone, or soft tissue so that its further eruption is unlikely. Pain, edema, trismus and inflammation followed by tissue injury are common postsurgical complications. Corticosteroids, like methylprednisolone, dexamethasone, or betamethasone, are potent inhibitors of inflammation because of their suppressive impact on the synthesis and release of inflammatory tissue mediators. The main objective of this study is to investigate the effect of methylprednisolone injection on the reduction of postsurgical complications like Pain and Trismus. We aim at comparing the efficacy of submucosal and massetric Methylprednisolone prior to impacted third molar surgery. Patients with Moderate Difficulty index of impacted mandibular third molar as per Pederson Difficulty Index between age of 21 to 40 years will be included in the study. Patients will be divided into Group A and B following randomisation. In one group submucosal methylprednisolone and in another group massetric methylprednisolone will be administered prior to surgical removal of mandibular third molar. Post operative complications like pain, trismus, swelling, and quality of life of the patients will be assessed. |