| CTRI Number |
CTRI/2025/03/083519 [Registered on: 26/03/2025] Trial Registered Prospectively |
| Last Modified On: |
26/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Other |
|
Public Title of Study
|
Analysis of association between maxillary sinus lateral wall thickness, Schneiderian membrane thickness and residual alveolar ridge height in dentate and partially edentulous patients: a CBCT study |
|
Scientific Title of Study
|
Analysis of association between maxillary sinus lateral wall thickness, Schneiderian membrane thickness and residual alveolar ridge height in dentate and partially edentulous patients: a cbct 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 Dhawal Mody |
| Designation |
Associate Professor |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
104, Department of Periodontics and Implantology
Ranjeet Deshmukh Dental College and Research Centre,
Digdoh Hills, Hingna road
Nagpur 440019
Maharashtra India
DIGDOH HILLS, HINGNA ROAD,Nagpur 440019
Maharashtra India
Nagpur
MAHARASHTRA
440019
India |
| Phone |
8055775977 |
| Fax |
|
| Email |
periowell@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhawal Mody |
| Designation |
Associate Professor |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
104, Department of Periodontics and Implantology
Ranjeet Deshmukh Dental College and Research Centre,
Digdoh Hills, Hingna road
Nagpur 440019
Maharashtra India
DIGDOH HILLS, HINGNA ROAD,Nagpur 440019
Maharashtra India
MAHARASHTRA
440019
India |
| Phone |
8055775977 |
| Fax |
|
| Email |
periowell@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhawal Mody |
| Designation |
Associate Professor |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
104, Department of Periodontics and Implantology
Ranjeet Deshmukh Dental College and Research Centre,
Digdoh Hills, Hingna road
Nagpur 440019
Maharashtra India
DIGDOH HILLS, HINGNA ROAD,Nagpur 440019
Maharashtra India
MAHARASHTRA
440019
India |
| Phone |
8055775977 |
| Fax |
|
| Email |
periowell@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ranjeet Deshmukh Dental College and Research Centre, Nagpur |
|
|
Primary Sponsor
|
| Name |
none |
| Address |
none |
| 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 Dhawal Mody |
Department of Periodontics and Implantology |
104, Department of periodontics,Ranjeet Deshmukh Dental College and Research Centre
Digdoh Hills Hingna road
Nagpur: 440019
Nagpur
MAHARASHTRA |
8055775977
periowell@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ranjeet Deshmukh Dental College and Research Centre Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients who can be classified as dentate or partially edentulou in posterior maxilla |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients in the age group of 19 to 70 years.
2) Edentulous patients undergoing implant treatment.
3) Patients with CBCT scans available for maxillary posterior regions.
4) Patients who can be classified as dentate or partially edentulous.
|
|
| ExclusionCriteria |
| Details |
1) History of maxillary sinus augmentation.
2) Patients with history of periodontal treatment during 6 month’s period.
3) Patients with signs of sinusitis.
4) Patients with history of systemic disease.
5) Patients with chronic or acute periapical lesions, oroantral fistulas or pathologies of the maxillary sinus
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and to assess the association between maxillary sinus lateral wall thickness, Schneiderian membrane thickness and residual alveolar ridge height in dentate and partially edentulous patients using CBCT scans. |
0, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To evaluate maxillary sinus Schneiderian membrane thickness in dentate & partially edentulous patients using CBCT.
2) To evaluate the maxillary sinus lateral wall thickness in dentate & partially edentulous patients using CBCT.
3) To evaluate residual alveolar ridge height in dentate & partially edentulous patients using CBCT.
4) To correlate sinus membrane thickness with maxillary sinus lateral wall thickness with residual alveolar ridge height in dentate & partially edentulous patients using CBCT.
|
0,6 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
18/04/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
The maxillary sinus is the largest paranasal air-filled space, developing first in utero. It is a pyramidal-shaped cavity in the facial skull with a mean volume of 12.5 mL. The mucous membrane, the Schneiderian membrane, covers the innermost layer of highly vascularized connective tissue. Mesenchymal stem cells from the sinus membrane can produce bone, essential for sinus floor elevation procedures. The thickness of the lateral wall of the maxillary sinus is crucial in surgical interventions such as Caldwell-Luc surgery, Lefort I osteotomy, open sinus lift, facial and jaw bone fracture fixation, and the diagnosis of chronic sinusitis. Maxillary sinus augmentation is performed using two surgical approaches: the lateral window approach and the crestal approach. The lateral window approach is considered more predictable in terms of outcome and safety, especially for cases with minimal bone height. CBCT scans are used for dental and maxillofacial imaging, offering advantages in isotropic volume resolution and reduced radiation doses. |