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CTRI Number  CTRI/2021/10/037639 [Registered on: 27/10/2021] Trial Registered Prospectively
Last Modified On: 23/10/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Single Arm Study 
Public Title of Study   Evaluation of bone changes on patients treated with basal/cortical implants: A radiographic study 
Scientific Title of Study   Evaluation of bone density, horizontal bone thickness and vertical bone height changes in patients rehabilitated with basal/cortical implants: A cone beam computed tomography study.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sayana Nazrine 
Designation  PG Student 
Affiliation  Rajarajeswari Dental College and Hospital 
Address  Room no 4,Department of Periodontology,Rajarajeswari Dental college and Hospital, No.14, Ramohalli Cross, Mysore Road, Kumbalgodu, Bengaluru, Karnataka 560074
Room no 4,Department of Periodontology,Rajarajeswari Dental college and Hospital, No.14, Ramohalli Cross, Mysore Road, Kumbalgodu, Bengaluru, Karnataka 560074
Bangalore
KARNATAKA
560074
India 
Phone  09945038228  
Fax    
Email  sayananazrine12@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shivaprasad BM 
Designation  PROFESSOR 
Affiliation  Rajarajeswari Dental College and Hospital 
Address  Room no 4,Department of Periodontology,Rajarajeswari Dental college and Hospital No.14, Ramohalli Cross, Mysore Road, Kumbalgodu, Bengaluru, Karnataka 560074
Room no 4,Department of Periodontology,Rajarajeswari Dental college and Hospital No.14, Ramohalli Cross, Mysore Road, Kumbalgodu, Bengaluru, Karnataka 560074
Bangalore
KARNATAKA
560074
India 
Phone  09945038228  
Fax    
Email  drspbmath@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shivaprasad BM 
Designation  PROFESSOR 
Affiliation  Rajarajeswari Dental College and Hospital 
Address  Room no 4,Department of Periodontology,Rajarajeswari Dental college and Hospital No.14, Ramohalli Cross, Mysore Road, Kumbalgodu, Bengaluru, Karnataka 560074
Room no 4,Department of Periodontology,Rajarajeswari Dental college and Hospital No.14, Ramohalli Cross, Mysore Road, Kumbalgodu, Bengaluru, Karnataka 560074
Bangalore
KARNATAKA
560074
India 
Phone  09945038228  
Fax    
Email  drspbmath@gmail.com  
 
Source of Monetary or Material Support  
Rajarajeswari Dental College and Hospital 
 
Primary Sponsor  
Name  Dr Sayana Nazrine 
Address  Rajarajeswari dental College and hospital Bangalore 
Type of Sponsor  Other [SELF] 
 
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 
DrSayana Nazrine  Rajarajeswari Dental College and Hospital  Room no 4,Department of Periodontology,Rajarajeswari Dental college and Hospital, No.14, Ramohalli Cross, Mysore Road, Kumbalgodu, Bengaluru, Karnataka 560074
Bangalore
KARNATAKA 		 09945038228

sayananazrine12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical Committee of Rajarajeswari dental college and hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K084||Partial loss of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  Placement of Basal/Cortical implants,CBCT  CBCT taken pre operative,immediate post operative and 12 months postoperative 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients of age between 25-60 with hopeless tooth/teeth.
2.Partially edentulous patients.
3.Medically fit patients.
4.Patients with failed implants/re-implant procedures.
5.Willingness to provide informed consent.
 
 
ExclusionCriteria 
Details  1.With previous history of chemotherapy or radiotherapy.
2.Patients with smoking habit.
3.Under the administration of bisphosphonates.
4.Diagnosed case of aggressive periodontitis.
5.Suffering from a known psychological problem due to difficulty in maintaining oral hygiene.
6.Patients with uncontrolled diabetes.
7.Recent history of myocardial infarction or cerebrovascular accident.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Evaluation of bone density, horizontal bone thickness and vertical bone height changes in patients rehabilitated with basal/cortical implants  basesline,12 months 
 
Secondary Outcome  
Outcome  TimePoints 
1) Modified bleeding index by Mombelli et al will be used to assess peri implant mucositis in the marginal area around the implant
2) Probing depth will be assessed around the implant sites  		 baseline,6 and 12 months 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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 3/ Phase 4 
Date of First Enrollment (India)   29/10/2021 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sayananazrine12@gmail.com].

  6. For how long will this data be available start date provided 29-10-2021 and end date provided 11-01-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   This study focuses on placement of Basal/cortical implants on partially edentulous patients or patients with hopeless prognosis teeth.Rehabilitation is done using basal/cortical implants followed by prosthesis placement.The bone density changes and horizontal and vertical dimensional changes are evaluated.Very minimal literatures have been published on basal/cortical implants.Hence the need for the study. 
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