| CTRI Number |
CTRI/2025/11/096820 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
02/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Mandibular second molar impaction in Indian population prevalence and role of third molars for treatment planning |
|
Scientific Title of Study
|
Mandibular Second Molar Impaction In Indian Population Prevalence, Associated Dental Anomalies, And The Role Of Third Molars |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Muskaan |
| Designation |
Student |
| Affiliation |
Manipal College Of Dental Sciences Manipal |
| Address |
Room no. 1 Department Of Oral Medicine and Radiology Manipal College of Dental sciences Madhav Nagar Eshwar Nagar Manipal 576104 Karnataka
Room no. 1 Department Of Oral Medicine and Radiology Manipal College of Dental sciences Madhav Nagar Eshwar Nagar Manipal 576104 Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9318422062 |
| Fax |
|
| Email |
Muskaan.mcodsma@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Komal Smriti |
| Designation |
Associate Professor |
| Affiliation |
Manipal college of dental sciences manipal |
| Address |
Room no. 1 department of oral medicine and radiology Manipal College of Dental sciences madhav Nagar eshwar Nagar Manipal 576104 Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9886314050 |
| Fax |
|
| Email |
Komal.smriti@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Komal Smriti |
| Designation |
Associate Professor |
| Affiliation |
Manipal college of dental sciences manipal |
| Address |
Room no. 1 department of oral medicine and radiology Manipal College of Dental sciences madhav Nagar eshwar Nagar Manipal 576104 Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9886314050 |
| Fax |
|
| Email |
Komal.smriti@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Muskaan |
| Address |
Room no. 1 Department Of Oral Medicine and Radiology Manipal College of Dental sciences Madhav Nagar Eshwar Nagar Manipal 576104 Karnataka |
| 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 Komal Smriti |
Manipal College of Dental Sciences |
Room no. 1 Department Of Oral Medicine and Radiology Manipal College of Dental sciences Madhav Nagar Eshwar Nagar Manipal 576104 Karnataka
Udupi
KARNATAKA |
9886314050
Komal.smriti@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and kasturba hospital institutional ethics committee-2 (student research) |
Approved |
|
|
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 |
NIL |
NIL |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients who walked into the OPD for routine dental checkups will be evaluated with MM2 and MM3 impaction and screening, collecting and analysing their orthopantomograph done by trained radiographers
2. At the time of second molar impaction detection, their age range was 14-70 years with a mean age
|
|
| ExclusionCriteria |
| Details |
1. Any patient with systemic bone disorders and underlying syndrome manifestations will be excluded
2. Patients with mixed dentition will be excluded
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Degree and severity of second mandibular molar impaction and its relation with the adjacent teeth and opposing teeth in the arch |
At baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="525"
Sample Size from India="525"
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)
|
15/11/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| 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
|
Orthopantomograms (OPGs) will be retrieved from the records of patients who present to the outpatient department (OPD) for routine dental examinations. These OPGs will be acquired by qualified radiographers adhering to established radiographic protocols. From the available OPGs, those meeting the pre-defined inclusion criteria will be selected. A standardized data collection form will be utilized to record the required information from each OPG. Trained and calibrated radiographers will analyze the selected OPGs. The data from the forms will be entered into a database (e.g., spreadsheet, statistical software) for subsequent analysis. Following parameters are evaluated Impaction Degree & Angulation: Evaluate the severity and angulation of the second mandibular molar impaction. Eruption Status: Determine whether the second molar is fully or partially erupted. Radiographic Evaluation: Use radiographic imaging to measure the angulation of the impacted molar relative to adjacent teeth and the mandibular body. Tooth Relationships: Assess the relationship of the impacted molar with adjacent and opposing (maxillary) teeth, as impaction may contribute to malocclusion. Root Development: Examine root development stage and morphology, which are key prognostic factors in impaction cases. Radiographic Risk: Radiographic evaluation involves minimal risk, with radiation exposure within standard care guidelines and not considered significant. |