| CTRI Number |
CTRI/2023/02/049512 [Registered on: 07/02/2023] Trial Registered Prospectively |
| Last Modified On: |
18/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To evaluate the effect of osseodensification technique on bone density around dental implants. |
|
Scientific Title of Study
|
A comparative evaluation of effect of osseodensification on bone density around dental implants: A randomized control trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhujbal Rushikesh Bhau |
| Designation |
Junior Resident |
| Affiliation |
King Georges Medical University,Lucknow |
| Address |
Dept Of Prosthodontics,Crowns and Bridges,
New Dental Building,
King Georges Medical University,
Lucknow,Uttar Pradesh.
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9096060601 |
| Fax |
|
| Email |
dr.rushibhujbal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooran Chand |
| Designation |
Professor and Head of the Department |
| Affiliation |
King Georges Medical University,Lucknow |
| Address |
Dept Of Prosthodontics,Crowns and Bridges,
New Dental Building,
King Georges Medical University,
Lucknow,Uttar Pradesh.
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9415173419 |
| Fax |
|
| Email |
dr.pooran_chand@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhujbal Rushikesh Bhau |
| Designation |
Junior Resident |
| Affiliation |
King Georges Medical University,Lucknow |
| Address |
Dept Of Prosthodontics,Crowns and Bridges,
New Dental Building,
King Georges Medical University,
Lucknow,Uttar Pradesh.
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9096060601 |
| Fax |
|
| Email |
dr.rushibhujbal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Prosthodontics,Crown And Bridges,
King Georges Medical University,
Lucknow. |
|
|
Primary Sponsor
|
| Name |
Bhujbal Rushikesh Bhau |
| Address |
Dept Of Prosthodontics,Crowns and Bridges,
New Dental Building,
King Georges Medical University,
Lucknow,Uttar Pradesh. |
| 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 Bhujbal Rushikesh Bhau |
King Georges Medical University |
Dept Of Prosthodontics,Crowns and Bridges,
6th floor,
New Dental Building,
King Georges Medical University,
Lucknow,Uttar Pradesh.226003
Lucknow
UTTAR PRADESH |
9096060601
dr.rushibhujbal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King Georges Medical University U.P.,Institutional Ethics Committee Lucknow-226003 (UP) India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
Conventional Technique (CT) Group |
Dental implants placed without osseodensification. |
| Intervention |
Osseodensification Technique(OT) group |
Dental implants placed with osseodensification. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Partial Edentulism in Maxilla.
2)Adequate Oral hygiene.
3)Adequate bone volume for implant placement. |
|
| ExclusionCriteria |
| Details |
1)Systemic Diseases.
2)Habit of smoking and chewing tobacco.
3)Bruxism
4)Bone diseases.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare osteoprotegrin level in periimplant crevicular fluid(PICF) from dental implants placed with osseodensification and conventional technique. |
1)2 weeks
2)12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare bone mineral density around dental implants placed with osseodensification and conventional technique. |
1)Pre-operative(Baseline)
2)2 weeks
3)12 weeks |
| To find association between osteoprotegrin and bone mineral density. |
1)2 weeks
2)12 weeks |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
10/02/2023 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Introduction
Dental implant is the part of the prosthesis
that interfaces the bone and supports
the dental prosthesis. It is a widely used treatment modality.
Primary stability in dental implants is an
essential factor for achieving successful osseointegration. Surgical procedure
and bone quality are among the most common factors that affect primary
stability. It is also crucial to achieve high-insertion torque which is
important for obtaining primary stability. Maintaining sufficient bone bulk and
density is essential to achieve necessary bone-to-implant contact for obtaining
a biomechanically stable implant. A new concept for osteotomy called
osseodensification (OD) has been at the forefront of changes in surgical site
preparation in implantology. It is done with specially designed
bur that has many lands with a large negative rake angle, which works as
noncutting edges to increase the density of the bone as they expand an
osteotomy.
The bone density corresponds to the bone
remodelling activity of osteoblast and osteoclast. Local factors like levels of
osteoprotegrin(OPG) has a significant role in it.
OPG is expressed by osteoblast.
The OPG protein is a novel member of TNF
family.It is a regulator of bone density that act locally and systematically by
negatively regulating osteoclast maturation.
Its expression is regulated by most of
the factors that induce RANKL expression by osteoblasts. OPG protects the skeleton from excessive bone resorption by
binding to RANKL and preventing it from binding to its receptor, RANK.
The aim of the present study is to comparatively evaluate
the effect of osseodensification technique on
bone mineral density.
RESEARCH HYPOTHESIS:
Null Hypothesis
It will be
hypothesized that there
is no significant change in bone mineral density and osteoprotegrin around
dental implants placed through conventional drilling protocol with osseodensification
and conventional drilling protocol.
Objective :
1)To compare osteoprotegrin
level in Periimplant crevicular
fluid(PICF) from dental implants placed with osseodensification and
conventional technique.
2) To compare bone mineral density
around implants placed with osseodensification and conventional technique.
3) To find association between
osteoprotegrin and bone mineral density.
This trial is in accordance with the
Consolidated Standards of Reporting Trails(CONSORT) criteria, 2010. |