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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
 
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 and 
immediately after preparation of the implant site when 
using the Densah Bur.  
Bone ridge width will be assessed at the same day of the surgery twice. Before and 
immediately after preparation of the implant site 
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 quotient 
(ISQ). ISQ uses resonance frequency analysis to determine if 
the newly prepared implant 
site is stable enough for 
immediate or early loading 
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.

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 




 
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