CTRI Number |
CTRI/2025/05/087044 [Registered on: 16/05/2025] Trial Registered Prospectively |
Last Modified On: |
15/05/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cohort Study |
Study Design |
Other |
Public Title of Study
|
Assessment of alveolar bone anatomy in maxilla and mandible using cbct |
Scientific Title of Study
|
Assessment of alveolar bone anatomy in maxillary and mandibular first and second molars using cone beam computed tomography retrospective morphometric 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 Kummari Sai Minil Kumar |
Designation |
Post graduate student |
Affiliation |
Kamineni Institute of Dental Sciences |
Address |
Department of Oral medicine and radiology
ground floor room number 1
Sreepura
Narketpally
Nalgonda TELANGANA 508254 India |
Phone |
8919837653 |
Fax |
|
Email |
saiminilomr@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Avinash Tejasvi ML |
Designation |
Professor and head of the department |
Affiliation |
Kamineni Institute of Dental Sciences |
Address |
Department of Oral medicine and radiology
ground floor room number 1 Sreepuram
Narketpally Nalgonda TELANGANA 508254 India |
Phone |
8096641123 |
Fax |
|
Email |
avinash.omr@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Avinash Tejasvi ML |
Designation |
Professor and head of the department |
Affiliation |
Kamineni Institute of Dental Sciences |
Address |
Department of Oral medicine and radiology
ground floor room number 1 Sreepuram
Narketpally
Nalgonda TELANGANA 508254 India |
Phone |
8096641123 |
Fax |
|
Email |
avinash.omr@gmail.com |
|
Source of Monetary or Material Support
|
Kamineni institute of dental sciences |
|
Primary Sponsor
|
Name |
Dr Kummari Sai Minil Kumar |
Address |
Kamineni institute of dental sciences |
Type of Sponsor |
Other [NIL] |
|
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 Sai minil kumar |
Kamineni institute of dental sciences |
Department of oral medicine and radiology ground floor room no 1 sreepuram narketpally Nalgonda TELANGANA |
08919837653
saiminilomr@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
InstitutionalEthicsCommittee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Intact first and second molar regions in the maxilla and mandible.
|
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Nil |
Nil |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
55.00 Year(s) |
Gender |
Both |
Details |
Patients aged from 18 years to 55 years.
High-quality CBCT scans with no artifacts obscuring the maxillary or mandibular regions.
Intact first and second molar regions in the maxilla and mandible.
|
|
ExclusionCriteria |
Details |
Scans with pathological conditions affecting the alveolar bone (e.g., tumors, cysts).
Patients with systemic conditions that significantly alter bone density (e.g. Osteoporosis, osteomalacia).
|
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Other |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To assess the alveolar bone dimensions such as socket morphology , height, width & cortical thickness of maxillary & mandibular 1st & 2nd molars in CBCT.
To evaluate the proximity of the maxillary sinus and inferior alveolar nerve to the Roots & Furcation of maxillary & mandibular 1st & 2nd molars.
To evaluate buccal bone & lingual bone thickness & Interradicular bone width .
To determine the influence of gender in assessment of roots of maxillary & mandibular 1st & 2nd molars.
|
BASE LINE OBSERVATION |
|
Secondary Outcome
|
Outcome |
TimePoints |
NIL |
NIL |
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
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)
|
10/07/2025 |
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="0" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
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
|
Immediate implant placement in the posterior regions of maxilla and mandible , particularly in the first and second molars area, possess unique anatomical and clinical challenges. These regions often exhibit variations in the alveolar bone height, width and morphology due to the factors such as tooth loss sinus proximity and bone resorption making precise preoperative evaluation essential to avoid complications like insufficient primary stability or implant failure. Understanding these parameters is crucial , as immediate implant placement not only reduces treatment time but also helps to preserve alveolar bone. AIM OF THE STUDY This study aims to evaluate anatomical bone variations in maxillary and mandibular first and second molars in relationship to maxillary sinus and IAN canal using cone beam computed tomography (CBCT). OBJECTIVES OF THE STUDY 1) To assess alveolar bone dimensions such as socket morphology such as height, width and cortical thickness of maxillary and mandibular molars in CBCT. 2) To evaluate the proximity of the maxillary sinus and inferior alveolar nerve to the root apices and furcations of maxillary and mandibular first and second molars. 3) To evaluate buccal bone and lingual bone thickness, inter radicular bone width. 4) To determine the influence of gender in assessment of roots of maxillary and mandibular first and second molars. CBCT scans will be analyzed for measuring bone height, bone width, cortical thickness and proximity to anatomical structures like maxillary sinus and inferior alveolar canal. Scans will be anonymized and data will be categorized based on gender and arch type ( Maxilla or Mandible). |