CTRI Number |
CTRI/2021/07/034554 [Registered on: 02/07/2021] Trial Registered Prospectively |
Last Modified On: |
25/06/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Other |
Public Title of Study
|
Increasing implant stability using bonedensification technique. |
Scientific Title of Study
|
Comparative Evaluation of Implant Stability Using Osseodensification Technique Versus Conventional Technique |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
CHITITHOTI RISHITHA |
Designation |
Post graduate |
Affiliation |
ANIL NEERUKONDA INSTITUTE OF DENTAL SCIENCES |
Address |
Depratment of periodontics
room number 6
Anil Neerukonda Institute of Dental Sciences
Sangivalasa
Visakhapatnam - 531162 Depratment of periodontics
room number 6
Anil Neerukonda Institute of Dental Sciences
Sangivalasa
Visakhapatnam - 531162 Visakhapatnam ANDHRA PRADESH 531162 India |
Phone |
8897134572 |
Fax |
|
Email |
chrishitha1@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Y V Sashi kanth |
Designation |
MDS |
Affiliation |
ANIL NEERUKONDA INSTITUTE OF DENTAL SCIENCES |
Address |
Depratment of periodontics
room number 6
Anil Neerukonda Institute of Dental Sciences
Sangivalasa
Visakhapatnam - 531162 Depratment of periodontics
room number 6
Anil Neerukonda Institute of Dental Sciences
Sangivalasa
Visakhapatnam - 531162 Visakhapatnam ANDHRA PRADESH 531162 India |
Phone |
9246675440 |
Fax |
|
Email |
yvsashikanth@gmail.com |
|
Details of Contact Person Public Query
|
Name |
CHITITHOTI RISHITHA |
Designation |
Post graduate |
Affiliation |
ANIL NEERUKONDA INSTITUTE OF DENTAL SCIENCES |
Address |
Depratment of periodontics
room number 6
Anil Neerukonda Institute of Dental Sciences
Sangivalasa Depratment of periodontics
room number 6
Anil Neerukonda Institute of Dental Sciences
Sangivalasa
Visakhapatnam Visakhapatnam ANDHRA PRADESH 523001 India |
Phone |
8897134572 |
Fax |
|
Email |
chrishitha1@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Anil Neerukonda Institute of Dental Sciences |
Address |
Depratment of periodontics
room number 6
Anil Neerukonda Institute of Dental Sciences
Sangivalasa
Visakhapatnam |
Type of Sponsor |
Other [Private Dental college] |
|
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 |
CHITITHOTI RISHITHA |
ANIL NEERUKONDA INSTITUTE OF DENTAL SCIENCES |
Depratment of periodontics
room number 6
Anil Neerukonda Institute of Dental Sciences
Sangivalasa
VISAKAPATNAM - 531162
Visakhapatnam ANDHRA PRADESH |
8897134572
chrishitha1@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
ANIDS institutional ethics committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: Z463||Encounter for fitting and adjustment of dental prosthetic device, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
conventional technique |
to evaluate primary and secondary implant stability using conventional drills. |
Intervention |
Osseodensification |
to evaluate the primary and secondary implant stability using osseodensification drills |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1) Adequate oral hygiene
2)Patients between 20 to 65 years
3)Patients with missing teeth in the posterior region |
|
ExclusionCriteria |
Details |
1)Medically compromised subjects. (uncontrolled diabetics)
2)General contraindications against implant treatment (radiotherapy, immunodeficiency, etc.).
3)Untreated, periodontal disease, or caries.
4)Pregnancy.
5)Heavy smoker (>10 cigarettes per day).
6)Poor oral hygiene.
7)Parafunctional habits.
8)Alcohol or drug abuse. |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Primary stability is measured immediately after implant placement.
|
Day 1
|
|
Secondary Outcome
|
Outcome |
TimePoints |
2. Primary and early secondary stability are measured at 6 weeks interval (healing abutment will be placed to avoid injury at the implant site).
3. Secondary implant stability is measured at the 12th week (before the abutment placement)
|
6th week, 12th week |
|
Target Sample Size
|
Total Sample Size="10" Sample Size from India="10"
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)
|
02/08/2021 |
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
|
Main Dissertation |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
The key vital role for the long term success of implant mainly depends on osseointegration. Osseointegrated implants have better bone quality and stability. The concept of osseointegration was introduced by BRANEMARK & Colleagues in the year 1969. This osseointegration was based on the primary stability, which was achieved immediately after the implant placement. To obtain biomechanically stable implants, high bone density and bone quality are the ideal requisites, indirectly resulting in better secondary stability. SALAH HUWAIS, in the year 2013, introduced a novel technique that helps in the densification of bone by autografting the individual’s bone within the osteotomy site wall. This in due results in creating a suitable environment for osteoblast nucleation on the autografted bone, which is close to the integrated implant body. Thus, new bone growth formation enhances within the osteotomy site. This physical and biomechanical interlocking results in higher primary stability values, which is mainly attributed to condensation and preservation of the bone by lateral compaction. This OSSEODENSIFICATION procedure has come under the limelight in recent times as it increases both the implants’ mechanical stability and peri-implant bone density. |