| CTRI Number |
CTRI/2017/08/009496 [Registered on: 25/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
22/06/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trial to demonstrate effectiveness of a new drill system ‘Densah’ in increasing bone width in sites of compromised bone while placing dental implants. |
|
Scientific Title of Study
|
Novel Implant Site preparation using Densah Burs Osseodensification: A Clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tarun Kumar AB |
| Designation |
Professor and Head Bapuji Implant centre |
| Affiliation |
Bapuji dental college & Hospital |
| Address |
room no 10
bapuji dental college and hospital
davangere
Davanagere KARNATAKA 577004 India |
| Phone |
9886210507 |
| Fax |
|
| Email |
tarundental@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Tarun Kumar AB |
| Designation |
Professor and Head Bapuji Implant centre |
| Affiliation |
Bapuji dental college & Hospital |
| Address |
room no 10
bapuji dental college and hospital
davangere
KARNATAKA 577004 India |
| Phone |
9886210507 |
| Fax |
|
| Email |
tarundental@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Kriti mehrotra |
| Designation |
Postgraduate student |
| Affiliation |
Bapuji dental college & Hospital |
| Address |
room no 5
bapuji dental college and hospital
davangere
Davanagere KARNATAKA 577004 India |
| Phone |
9741700660 |
| Fax |
|
| Email |
kriti1004@gmail.com |
|
|
Source of Monetary or Material Support
|
| Investigator initiated.
No external monetary support
Dr Tarun Kumar AB
Room no 10 bapuji dental college and hospital davangere |
|
|
Primary Sponsor
|
| Name |
Dr Tarun Kumar AB |
| Address |
dr Tarun kumar AB
room no 10
Bapuji dental college and hospital
davangere |
| 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 |
| Tarun Kumar AB |
Bapuji Implant centre |
room no. 10,
Bapuji dental college & hospital, davangere Davanagere KARNATAKA |
9886210507
tarundental@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review board, Bapuji dental college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with one or more missing teeth in maxilla or mandible requiring implant supported fixed restoration., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Implant site preparation using Densah Bur |
Densah bur would be used to create osteotomy site. Bone ridge width pre and post osteotomy would be measured to assess if any change has occured. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having atleast one edentulous site with healthy adjacent teeth.
2.Edentulous ridge width of atleast 3mm as determined from CBCT
3.Patients with good oral hygiene (Oral Hygiene Index Simplified < 1.3)
4.Patients having good systemic health with no contradiction for implant surgery like uncontrolled diabetes, uncontrolled hypertension.
5.Capable of giving informed consent
|
|
| ExclusionCriteria |
| Details |
1.An immunocompromised medical history that would complicate the outcome of the procedure.
2.Patient smoking more than 5 cigarettes per day
3.Patient has a history of alcoholism or drug abuse during the last 5 years
4.Insufficient interarch space to accommodate the prosthodontics component.
5.Dental history of bruxism, Para functional oral habit and /or lack of stable posterior occlusion.
6.Pregnant and /or lactating mothers.
7.Patients who are uncooperative.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Bone ridge width before andÂ
immediately after preparation of the implant site whenÂ
using the Densah Bur. |
Bone ridge width will be assessed at the same day of the surgery twice. Before andÂ
immediately after preparation of the implant siteÂ
using the Densah Bur. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| insertion torque value(ITV).ITV is a measure of the rotational friction between the implant and the surrounding bone |
ITV will be measured on the day of the surgery at the time of implant insertion |
implant stability quotientÂ
(ISQ). ISQ uses resonance frequency analysis to determine ifÂ
the newly prepared implantÂ
site is stable enough forÂ
immediate or early loadingÂ
of the actual dental implant. |
ISQ will be measured on the day of the surgery immediately after implant placement and 6 weeks after main surgery. |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
03/08/2016 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Huwais S. Enhancing implant stability with osseodensification — a case report with 2-year follow-up. Implant practice ;8(1):28-34 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Need for the study
Endosseous dental implants are
now considered to be the treatment of choice for replacement of all forms of
tooth loss. An essential condition for successful implant therapy is the
presence of an adequate quantity and quality of bone. If a tooth or teeth have been missing for a
considerable period of time, or if there has been traumatic loss of tooth and
bone, placement of implants may prove challenging and often requires elaborate
bone-grafting procedures. Unfortunately, bone-grafting techniques require a
longer treatment time, a need for a second surgical appointment, and an
additional surgical site if autogenous bone is used1. This
is more important in recent days due to popular immediate loading protocols
being implemented into treatment by many clinicians. Standard
drill designs used in dental implantology are made to excavate bone to create
room for implant placement. They cut away bone effectively but typically do not
produce a precise circumferential osteotomy. Osteotomies may become elongated
and elliptical due to chatter of the drills. In these circumstances, the
implant insertion torque is reduced leading to poor primary stability and
potential lack of integration. Osteotomies drilled into narrow bone locations
may produce dehiscence, buccally or lingually, which also reduces primary
stability and will require an additional bone grafting. For more than a decade,
clinicians have been asking for improvement in bone drilling and preparation. 2Improvements
in surgical technique will present better prospects for improving clinical
results.3Unlike standard surgical technique, bone condensing
technique aims to maintain most of the existing bone and to compress it
apicolaterally. Thicker trabeculae and reduced intertrabecular spaces mean enhanced
microstructure of local bone that improves primary implant stability allowing
earlier new bone formation.4 Dr.
Salah Huwais came up with the concept of osseodensification, a novel
biomechanical implant site preparation technique. It produces low plastic
deformation of bone due to its non-excavation osteotomy preparation method
leading to expansion of pilot hole. Preservation of bone bulk takes place
during drilling, so bone tissue is simultaneously compacted. and autografted in
an outwardly expanding direction to form the osteotomy. It is accomplished by
using multifluted proprietary densifying burs- Densah Burs. 5 To the best of our knowledge very
few studies have been conducted to know about the efficacy of Densah burs in
achieving Osseodensification. Our study will be an effort in this direction. 1.
Research hypothesis (H1) : Densah Bur results in increased
bone ridge width while maintaining Implant stability. 2.
Null hypothesis (H0) :
Densah Bur does not result
in increased bone ridge width while maintaining Implant stability. Objectives of the study 1)
To evaluate Bone
ridge width before and immediately after preparation of the implant site when
using the Densah Bur . 2)
To evaluate
insertion torque value (ITV) of implant.
3)
To evaluate implant
stability quotient (ISQ). CLINICAL PARAMETERS : At the baseline
visit the study outcome data will be collected; including: 1) Measuring the bone ridge width, prior
and post implant site preparation (drilling) at two levels- crestal & a
position 10 mm apical to the crest using bone gauge. 2) Intraoral photographs of the prepared
opening 3) Dental implant torque readings will be
obtained post implant placement (ITV) (in Ncm).
4) ISQ as measure of both initial and the
dynamic development of osseointegration
|