| CTRI Number |
CTRI/2024/08/071893 [Registered on: 05/08/2024] Trial Registered Prospectively |
| Last Modified On: |
12/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A study to measure and compare the implant fixation to bone and mass of the bone of implants placed with two different techniques reverse rotation and osseodensification drilling technique in implants placed in upper arch |
Scientific Title of Study
Modification(s)
|
Comparative evaluation of Implant Stability and Bone Density in implants placed
in the maxillary arch using osseodensification and reverse surgical drilling techniques A randomized controlled 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 Vishva Vachhani |
| Designation |
Post graduate student |
| Affiliation |
K M Shah Dental College and Hospital |
| Address |
No 9 Department of Prosthodontics crown and bridge K M Shah Dental College and Hospital Sumandeep Vidyapeeth Pipariya Waghodia Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9428791315 |
| Fax |
|
| Email |
vishvavachhani1@gmal.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Paranjay Prajapati |
| Designation |
Professor |
| Affiliation |
K M Shah Dental College and Hospital |
| Address |
No 9 Department of Prosthodontics crown and bridge K M Shah Dental College and Hospital Sumandeep Vidyapeeth Pipariya Waghodia Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9725440155 |
| Fax |
|
| Email |
pgp2329@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishva Vachhani |
| Designation |
Post graduate student |
| Affiliation |
K M Shah Dental College and Hospital |
| Address |
No 9 Department of Prosthodontics crown and bridge K M Shah Dental College and Hospital Sumandeep Vidyapeeth Pipariya Waghodia Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
942879315 |
| Fax |
|
| Email |
vishvavachhani1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Material support from K M Shah dental college and hospital sumandeep vidyapeeth pipariya
waghodia vadodara gujarat 391760 |
|
|
Primary Sponsor
|
| Name |
Dr Vishva Vachhani |
| Address |
No 9 Department of Prosthodontics crown and bridge K M Shah Dental College and Hospital Sumandeep Vidyapeeth Pipariya Waghodia Vadodara-391760 |
| 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 Vishva Vachhani |
K M Shah Dental College and Hospital Sumandeep Vidyapeeth |
No 9 Department of
prosthodontics crown
and bridge K M Shah dental college
and hospital
sumandeep vidyapeeth
pipariya waghodia
vadodara gujarat
Vadodara
GUJARAT
Vadodara
GUJARAT |
9428791315
vishvavachhani1@gmal.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics committee |
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 |
osseodensification drilling technique |
this technique requires the different sets of drills which is densah burs. this burs also works in counterclockwise direction. |
| Intervention |
reverse drilling technique |
this is the modification in conventional drilling technique for the osteotomy for implant placement. in this technique normal conventional drills will be used but in a counterclockwise manner. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
a Subjects more then or equal to 18 years
b Patient who needs minimum of 2 implants in the maxillary arch
c If completely edentulous patients needs fixed implant prosthesis
d Both the implants site nearly of the same density
e Able to provide consent |
|
| ExclusionCriteria |
| Details |
a Patients with medical history in which any dental intervention would be
contraindicated
b Patients with known allergy to dental implant material (Titanium)
c Patients in which sinus lift procedures should be carried out for the implant
placement
d Patients in which bone graft is needed at the implant placement site
e Patient who is current smoker or quieted smoking less then 1 year
f Patients undergoing radiotherapy cancer therapy or drug that interfere with the
study
g completely edentulous patients needed implant supported removable prosthesis
h Presence of systemic diseases producing oral manifestations
i Patients suffering from any bone related systemic diseases
j Patients with any local or systemic disease, condition or medication that might
compromise health of the periodontium
k Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
implant stability
bone density |
implant stability at baseline, 1, 3 and 6 months after implant placement
bone density at baseline and after 6 months of implant placement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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)
|
27/08/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a paired split mouth randomised controlled trail comparing and evaluating the implant stability and bone density in two different drilling protocols i.e. reverse drilling protocol and osseodensification drilling protocol in partially or completely edentulous patients receiving atleast 2 implants fixed prosthesis in maxillary arch. Patients will be recruited after giving participants information sheet in the simplified language and after taking consent for the trail. A total of 24 implants in 12 patients, one osteotomy site will be prepared with reverse drilling technique and another osteotomy site will be prepared with densah burs and this will be randomly allocated in each patient’s left or right side of the maxilla as per the computer generated random numbers. After this the implant stability will be checked at baseline, 1, 3 and 6 months after implant placement and bone density will be checked at baseline with the RFA device and bone density will be checked at baseline and after 6 months of implant placement with the HU unit in sectional CBCT. This data will be analysed and results will be statistically evaluated. |