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CTRI Number  CTRI/2019/03/018286 [Registered on: 26/03/2019] Trial Registered Prospectively
Last Modified On: 25/03/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   evaluation of bone formation and blood supply around zirconium and titanium implants 
Scientific Title of Study   Comparative evaluation of hard tissue and soft tissue response around Zirconium and Titanium implants using CBCT and ultrasound Doppler flowmetry. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  KORADA SAI SIRSHA 
Designation  POST GRADUATE STUDENT 
Affiliation  Dr NTR UNIVERSITY OF HEALTH SCIENCES 
Address  ST JOSEPH DENTAL COLLEGE DUGGIRALA ELURU WEST GODAVARI ANDHRA PRADESH

West Godavari
ANDHRA PRADESH
534004
India 
Phone  9553266377  
Fax    
Email  saisirishakorada77@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr M NARENDRA BABU 
Designation  PROFESSOR  
Affiliation  Dr NTR UNIVERSITY OF HEALTH SCIENCES 
Address  ST JOSEPH DENTAL COLLEGE DUGGIRALA ELURU DISTRICT WEST GODAVARI ANDHRA PRADESH

West Godavari
ANDHRA PRADESH
534003
India 
Phone  9948544799  
Fax    
Email  plaque3456@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr P ARAVINDH KUMAR 
Designation  PROFESSOR 
Affiliation  Dr NTR UNIVERSITY OF HEALTH SCIENCES 
Address  ST JOSEPH DENTAL COLLEGE DUGGIRALA ELURU WEST GODAVARI DISTRICT ANDHRA PRADESH PIN CODE 534003

West Godavari
ANDHRA PRADESH
534003
India 
Phone  9948544799  
Fax    
Email  pavuluriak@gmail.com  
 
Source of Monetary or Material Support  
ST JOSEPH DENTAL COLLEGE AND HOSPITAL 
 
Primary Sponsor  
Name  korada sai sirisha 
Address  ST JOSEPH DENTAL COLLEGE DUGGIRALA ELURU WEST GODAVARI ANDHRA PRADESH INDIA PIN CODE 534003 
Type of Sponsor  Other [other] 
 
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 
korada sai sirisha  DUGGIRALA  ST JOSEPH DENTAL COLLEGE DUGGIRALA ELURU ANDHRA PRADESH
West Godavari
ANDHRA PRADESH 
9553266377

saisirishakorada77@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  edentulous patients 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BLOOD FLOW AND BONE DENSITY  DBCT AND DOPPLER FLOW METRY 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  adult males or females with one or more edentulous site in either maxilla or mandible and patients with good systemic health 
 
ExclusionCriteria 
Details  any systemic illness that effects periodontium are contraindicated for implant placement.patients with psychiatric disorders.inability or unwillingness to complete the trial.poor oral hygiene. pregnant, lactating mothers. history of smoking and alcohol 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
immeditely after implant placement  base line and after 10 days 
 
Secondary Outcome  
Outcome  TimePoints 
after osseointegration of implants  after 12 months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   01/04/2019 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NONE YET 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Titanium has become a gold standard as a base for implant placement. The newly emerging Zirconia implants are bio compatible and mechanically stable. Cone beam Computed tomography (CBCT) can be used for the objective quantification of direct density measurements of bone, expressed in Hounsfield units (HU) and bone quality changes by fractal dimension analysis.

Doppler ultrasonography is a non-invasive, accurate and simple technique to measure continuous microcirculatory blood flow in  peri- implant soft tissues .The objectives of this study:To compare and evaluate   bone mineral density in Hounsfield units (HU) in Zirconium and Titanium implants .  To compare and evaluate trabecular bone microstructure by Fractal Dimension(FD) in Zirconium and Titanium implants.  To compare evaluate crestal bone loss in Zirconium and Titanium dental implants. To compare peri-implant vascularity of Zirconium and Titanium dental implants. Patients attending outpatient department of  Periodontics St Joseph Dental College (SJDC). 

Patients in mean age group between 25 to 55 years and partially edentulous areas will be randomly selected for double blind clinical trial. 20 implants will be placed using roll of dice method . All the patients will be assessed for Bone Mineral Density (BMD) in Hounsfield units (HU) and Trabecular bone microstructure by Fractal Dimension (FD) analysis using CBCT and crestal bone loss using RVG around Zirconium and Titanium implants at baseline and one year after placement of implants.

Vascular flow in peri-implant mucosa will also be assessed by ultrasound Doppler flowmetry at baseline (before placement of the Implant) and on the 10th day post operatively.

Inclusion criteria:

•       Patients of mean age group between 25 to 55 years.

•       Patients with one or more edentulous site in either maxilla or mandible.

•       Good systemic health.

         

Exclusion criteria:

•       Any systemic disease that affects the periodontium are contraindicated for implant placement.

•       Patients with psychiatric disorders.

•       Inability or unwillingness to complete the trial

•       Poor oral hygiene

•       Pregnant, lactating mothers.

•       History of smoking and alcohol


 
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