| CTRI Number |
CTRI/2018/06/014449 [Registered on: 07/06/2018] Trial Registered Prospectively |
| Last Modified On: |
17/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
This study is to assess jaw bone density at various sites in the mouth where teeth are missing using a machine called CBCT and compare the bone density by using microscopic method |
|
Scientific Title of Study
|
Assessment of jaw bone density at implant sites- A radiographic and histomorphometric comparative study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Veera Kumari Merneedi |
| Designation |
Post graduate student |
| Affiliation |
Vishnu Dental College |
| Address |
Room No 1
Department of Oral medicine and radiology
Block 3
Vishnu Dental College
Vishnupur
Bhimavaram 534202
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
07416307669 |
| Fax |
|
| Email |
doctorkumari1989@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRSUDHAKARA REDDY |
| Designation |
Professor and Head |
| Affiliation |
Vishnu Dental College |
| Address |
Room No 1
Department of Oral medicine and radiology
Block 3
Vishnu Dental College
Vishnupur
Bhimavaram 534202
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9848599049 |
| Fax |
|
| Email |
sudhakarareddyomr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DRSUDHAKARA REDDY |
| Designation |
PROFESSOR AND HEAD OF DEPARTMENT |
| Affiliation |
VISHNU DENTAL COLLEGE |
| Address |
ROOM NO 1
DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY
BLOCK 3
VISHNU DENTAL COLLEGE
VISHNUPUR
BHIMAVARAM 534202
ROOM NO 1
DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY
BLOCK 3
VISHNU DENTAL COLLEGE
VISHNUPUR
BHIMAVARAM 534202
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9848599049 |
| Fax |
|
| Email |
sudhakarareddyomr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College
Bhimavaram |
|
|
Primary Sponsor
|
| Name |
Dr Veerakumari Merneedi |
| Address |
Room No 1
Department of Oral medicine and radiology
Block 3
Vishnu Dental College
Vishnupur
Bhimavaram 534202 |
| 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 Veera kumari Merneedi |
Vishnu Dental College |
Room No 1
Department of Oral medicine and radiology
Block 3
Vishnu Dental College
Vishnupur
Bhimavaram 534202
West Godavari
ANDHRA PRADESH |
07416307669
08816250894
doctorkumari1989@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy individuals who are in requirement of replacement of missing teeth |
| Patients |
(1) ICD-10 Condition: Z761||Encounter for health supervision and care of foundling, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Subjects between the age group of 20-50 years who will be advised cone beam computed tomography for implant placements.
Patients with no diseases affecting bone density and either fully or partially edentulous.
|
|
| ExclusionCriteria |
| Details |
TECHNICAL FACTORS:
Image distortion due to either patient movement during exposure or improper position of patient for exposure.
PATIENT FACTORS:
Patients with presence of pathology and fractures
Patients with congenital abnormalities.
Patients below 20 years and above 50 years of age
Patients with pregnancy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the bone density of dental implant sites using CBCT
2. To evaluate the bone quality of dental implant sites using histomorphometric tissue specimens.
|
6 months post extraction
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 3. To determine the correlation between CBCT caliberated grey values in terms of Hounsfeild units with Histomorphometric analysis. |
6 months post extraction |
|
|
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)
|
14/06/2018 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
|
A
Study was conducted at Vishnu dental college to assess and compare jaw bone
density at implant sites by using CBCT
and bone histomorphometry. Dental implant is a surgical component that
interfaces with the bone of jaw to support a dental prosthesis or act as
orthodontic anchor. Bone density in
the recipient implant site seems to be an important factor for long term
success of implant. A density scale helps clinicians to avoid placement of
implants into the very poorest qualities of bone, where failure is more
likely to occur.
|
Bone
density is the amount of bone mineral in bone tissue. It can be evaluated by
Hounsfield units (HU) through CBCT imaging which are directly related to
tissue attenuation coefficients which are range of optimal bone densities
associated with acquired primary implant stability Nevertheless, the success of an implant placement primarily depends
on quality of bone3 for which CBCT imaging may not be accurate
method because of its discrepancy in the attenuation coefficients. | |
Qualitative analysis of bone
architecture is primarily achieved using bone histomorphometry which provides
valuable information on the amount of bone and its cellular activity which is considered as a gold
standard procedure. It is
the only method for the direct in
situ analysis of bone
cells and their activities.
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