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CTRI Number  CTRI/2024/07/070894 [Registered on: 19/07/2024] Trial Registered Prospectively
Last Modified On: 16/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Radiation Therapy 
Study Design  Other 
Public Title of Study   Thickness of Sinus membrane in healthy individuals and individuals with periodontal disease using Cone Beam Computed Tomography 
Scientific Title of Study   Sinus membrane thickness in Periodontally healthy and Stage III Periodontitis patients and its correlation with anatomical parameters using Cone Beam Computed Tomography 
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 Abhay Kolte  
Designation  Dean and HOD 
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

Nagpur
MAHARASHTRA
440019
India 
Phone  9011071467  
Fax    
Email  drabhaypkolte@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abhay Kolte  
Designation  Dean and HOD 
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

Nagpur
MAHARASHTRA
440019
India 
Phone  9011071467  
Fax    
Email  drabhaypkolte@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Abhay Kolte  
Designation  Dean and HOD 
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

Nagpur
MAHARASHTRA
440019
India 
Phone  9011071467  
Fax    
Email  drabhaypkolte@gmail.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhay Kolte   Ranjeet Deshmukh Dental College and Research Centre  104, Department of Periodontics and Implant Dentistry, Ranjeet Deshmukh Dental College and Research Centre, Nagpur 440019
Nagpur
MAHARASHTRA 		 9011071467

drabhaypkolte@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cone beam Computed Tomography  Evaluation and comparison of sinus membrane thickness in periodontally healthy and Stage III Periodontitis using Cone Beam Computed Tomography 
Comparator Agent  Sinus membrane thickness  Sinus membrane thickness evaluation and comparison in periodontally healthy and Stage III Periodontitis patients and its correlation with anatomical parameters 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients who are willing to participate and sign the informed consent for this clinical trial.
Patients in the age group of 19 to 65 years.
Patients will be divided as
Group I- 40 Periodontally healthy patients requiring implant treatment (presence of at least one of first and second molars or second premolars in each left or right quadrants)
Group II- 40 Stage III Periodontitis patients requiring periodontal surgical treatment (presence of at least one of first and second molars or second premolars in each left or right quadrants, PPD more than 6mm , CAL more than 5mm )
 
 
ExclusionCriteria 
Details  History of maxillary sinus augmentation.
Patients with history of periodontal treatment during 6 month’s period.
Patients with signs of acute non-odontogenic sinusitis.
Patients with history of systemic disease.
Patients with chronic or acute periapical lesions, oroantral fistulas or pathologies of the maxillary sinus.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the correlation of sinus membrane thickness in periodontally healthy and stage III Periodontitis patients with anatomical parameters using CBCT.  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate sinus membrane thickness in periodontally healthy & Stage III Periodontitis patients using CBCT  Baseline 
To evaluate the distance between the medial & lateral walls of the maxillary sinus in periodontally healthy & Stage III Periodontitis patients using CBCT  Baseline 
To evaluate maxillary sinus angle & maxillary sinus width in periodontally healthy & Stage III periodontitis patients using CBCT  Baseline 
To evaluate the sinus membrane thickness at the point of maximum thickness along the sinus floor in periodontally healthy & Stage III Periodontitis patients using CBCT  Baseline 
To correlate sinus membrane thickness with the distance between the medial & lateral walls of maxillary sinus in periodontally healthy & Stage III Periodontitis patients using CBCT  Baseline 
To correlate sinus membrane thickness with maxillary sinus angle & maxillary sinus width in periodontally healthy & Stage III Periodontitis patients using CBCT  Baseline 
To correlate sinus membrane thickness with the point of maximum thickness along sinus floor in periodontally healthy & Stage III Periodontitis patients using CBCT  Baseline 
 
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)   28/07/2024 
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)   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  

This cross-sectional study will be conducted to evaluate correlation of sinus membrane thickness in periodontally healthy and stage III Periodontitis patients with anatomical parameters using CBCT.

 

Total of 80 subjects with age range of 19-65 years including both males and females visiting the Department of Periodontics at Ranjeet Deshmukh Dental College and Research Centre, Nagpur will be recruited.

Total of 80 participants, healthy and with Stage III periodontitis, as per the inclusion criteria will participate in the study.

The participants will be divided Patients will be divided as:

a)      Group I- 40 Periodontally healthy patients requiring implant treatment (presence of at least one of first and second molars or second premolars in each left or right quadrants)

b)      Group II- 40 Stage III Periodontitis patients requiring periodontal surgical treatment (presence of at least one of first and second molars or second premolars in each left or right quadrants, PPD > 6mm ,CAL > 5mm )

Written informed consent will be taken from the patients who wish to enroll in the study. Sinus membrane thickness is evaluated using Cone Beam Computed Tomography. PPD and CAL will be assessed clinically.

 
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