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
|
|
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
|
|
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
|