| CTRI Number |
CTRI/2025/07/091663 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effect of densa burs on low bone density patient on implant stability and bone loss with conventional burs |
|
Scientific Title of Study
|
A Comparative Evaluation of Implant Stability and Crestal Bone Levels Around Implants Placed by osseodensification drill and conventional technique in low density bone: clinicoradiographical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pawan Kumar |
| Designation |
Post graduate student |
| Affiliation |
Government Dental College and Hospital Chhatrapati Sambhajinagar |
| Address |
Room number 154, 1st floor, Government Dental College and Hospital, Chhatrapati Sambhajinagar
Aurangabad MAHARASHTRA 431001 India |
| Phone |
9665555154 |
| Fax |
|
| Email |
Pawankumar151997@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrMaya S Indurkar |
| Designation |
Dean, Professor and PG guide |
| Affiliation |
Government Dental College and Hospital Chhatrapati Sambhajinagar |
| Address |
Room number 154, 1st floor, Government Dental College and Hospital, Chhatrapati Sambhajinagar
Aurangabad MAHARASHTRA 431001 India |
| Phone |
9823182694 |
| Fax |
|
| Email |
mayaindurkar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DrMaya S Indurkar |
| Designation |
Dean, Professor and PG guide |
| Affiliation |
Government Dental College and Hospital Chhatrapati Sambhajinagar |
| Address |
Room number 154, 1st floor, Government Dental College and Hospital, Chhatrapati Sambhajinagar
Aurangabad MAHARASHTRA 431001 India |
| Phone |
9823182694 |
| Fax |
|
| Email |
mayaindurkar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr.Pawan Kumar |
| Address |
Government Dental College and Hospital Chhatrapati Sambhajinagar |
| 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 |
| DrPawan Kumar |
Government Dental College and Hospital |
Room no 154 1st floor Department of Periodontology Government Dental College and Hospital, Navkhanda, Chhatrapati Sambhajinagar, Maharashtra 431001 Aurangabad MAHARASHTRA |
9665555154
Pawankumar151997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Partially edentulous jaw |
| Patients |
(1) ICD-10 Condition: K081||Complete loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional drilling |
Conventional drilling will be done using conventional drilling system. |
| Intervention |
osseodensification |
Osseodensification will be done using densa burs drilling |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient in age range of 25 to 65 years.
2. Systemically healthy patients who are either partially edentulous with a single tooth missing were included in the study.
3. Patient who required implant supported prosthesis having good oral hygiene
4. Single tooth missing with D3 350 to 850 HU and D4 150 to 350 HU bone with adjacent and opposite tooth present.
|
|
| ExclusionCriteria |
| Details |
1) Smoking and/or chewing tobacco.
2) Patients with psychosis or history of bruxism and other parafunctional habits.
3) Pregnant/ Lactating patients.
4) Patients with systemic diseases like uncontrolled diabetes mellitus or other disorders affecting bone metabolism.
5) Patients with bleeding disorder.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Implant stability |
Baseline, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Crestal bone loss |
Baseline, 3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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 4 |
|
Date of First Enrollment (India)
|
30/07/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Implant therapy
has been a very popular and successful treatment for both partial and total
tooth loss in the last few decades. Osseointegration, which is the apparent
direct attachment or connection of an osseous tissue to an inert, alloplastic
material without intervening fibrous connective tissue. Achieving sufficient
stability during the initial surgical placement is critical to the
effectiveness of implant therapy and is impacted by a number of factors,
including bone density, surgical technique, and implant design.
Low bone
density might make it difficult to achieve adequate primary stability, which
can cause healing to be delayed and success rates to be lower. The
osseodensification technique was created as a novel way to improve bone density
during the drilling process in order to address this problem. In contrast to
conventional drilling techniques, osseodensification entails a non-subtractive
drilling procedure that densifies the bone around the implant site.
By
compacting the bone around the osteotomy site, osseodensification aims to
improve the implant’s initial stability. Better physical interlocking between
the implant and the bone is not the only benefit of this the presence of
instrumented bone, which stimulates the production of new bone cells, also
speeds up bone growth.
Essentially,
by increasing primary stability and encouraging faster bone healing,
osseodensification is a viable way to raise implant therapy success
rate especially where bone density is a limiting factor. A single
tooth loss is thought to be a frequent source of cosmetic difficulties, since
it can have psychological effects and result in non-physiologic occlusion due
to neighbouring teeth tipping and opposing natural teeth supra-erupting.
One of the most popular ways to prepare an implant bed is to utilise
instruments one size smaller than the implant’s diameter to prepare the
location. In order to produce an insertion site for implants, this approach
involves removing bone, which makes it challenging to provide the best primary
stability at sites deficient in both amount and quality of bone.
Osseodensification
is a recently developed biomechanical implant site preparation technique.
During osteotomy preparation, the technique is characterised by low plastic
deformation of bone, which is produced by rolling and sliding contact with a
fluted densifying bur that densifies the bone with minimal heat elevation and
allows for bone preservation and condensation through compaction autografting.
This increases the density of bone in the peri-implant areas and enhances the
mechanical stability of the implant.
Not many human studies have been conducted to compare
conventional and osseodensification.
Hence, in this study we are evaluating stability and
bone loss around implants placed using conventional and osseodensification. |