| CTRI Number |
CTRI/2021/04/033123 [Registered on: 26/04/2021] Trial Registered Prospectively |
| Last Modified On: |
01/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison between conventional osteotomy and osseodensification technique |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF HARD AND SOFT TISSUE CHANGES AROUND DENTAL IMPLANTS PLACED WITH OSSEODENSIFICATION IN CONTRAST WITH CONVENTIONAL OSTEOTOMY TECHNIQUE: AN IN VIVO STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajiv Kumar Gupta |
| Designation |
Professor |
| Affiliation |
Institute of Dental studies and technologies |
| Address |
IDST dental college kadrabad modinagar pin 201201
department of prosthodontics room no 9 idst dental college kadrabad modinagar pin 201201
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
07795656715 |
| Fax |
|
| Email |
dent.rajiv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajiv Kumar Gupta |
| Designation |
Professor |
| Affiliation |
Institute of Dental studies and technologies |
| Address |
IDST dental college kadrabad modinagar pin 201201
department of prosthodontics room no 9 idst dental college kadrabad modinagar pin 201201
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
07795656715 |
| Fax |
|
| Email |
dent.rajiv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajiv Kumar Gupta |
| Designation |
Professor |
| Affiliation |
Institute of Dental studies and technologies |
| Address |
IDST dental college kadrabad modinagar pin 201201
department of prosthodontics room no 9 idst dental college kadrabad modinagar pin 201201
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
07795656715 |
| Fax |
|
| Email |
dent.rajiv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Dental Studies and Technologies |
|
|
Primary Sponsor
|
| Name |
Institute of Dental Studies and Technologies |
| Address |
department of prosthodontics room no 9 idst kadrabad modinagar 201201 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| abin mathew abraham |
Institute of Dental Studies and Technologies |
Institute of Dental Studies and Technologies
Near Jain Shikanji Restaurant
Modinagar 201201
Ghaziabad
UTTAR PRADESH |
7795656715
abinabraham777@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of Dental Studies and Technologies |
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 |
| Intervention |
conventional osteotomy |
a crestal incision will be given and full thickness flap will be raised under local anesthesia and implant will be placed with conventional osteotomy technique |
| Comparator Agent |
osseodensification technique |
a crestal incision will be given and full thickness flap will be raised under local anesthesia and implant will be placed with osseodensification technique |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Partially edentulous sites both maxillary and mandibular arches
Ability and willingness of the patients to follow the study protocol
Adequate bone width and height at the site of implant placement
No signs of TMJ disorders
|
|
| ExclusionCriteria |
| Details |
General contraindications to implant surgery
Uncontrolled diabetes
Bruxism
Temporomandibular disorder
Heavy smokers
Chronic bone disease
Psychiatric disorders
Unrealistic expectations of the patient
Inability to adhere to planned follow up
Incapacity to give informed consent
Participation in other clinical trial interfering with present protocol
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
A crestal incision will be given and flap will be raised in the desired region under local anesthesia Implants will be placed using conventional osteotomy and osseodensification technique
Early loading will be done for all implants with temporary prosthesis and will be restored with definitive prosthesis
Standardized follow up time will be 2 3 4 and 6 months after placement of implant to assess the hard and soft tissue behavior using various tests and indices |
Standardized follow up time will be 2 3 4 and 6 months after placement of implant to assess the hard and soft tissue behavior using various tests and indices |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Early loading will be done for all implants with temporary prosthesis and will be restored with definitive prosthesis
Standardized follow up time will be 2 3 4 and 6 months after placement of implant to assess the hard and soft tissue behavior using various tests and indices |
2 months 4 months 6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
26/04/2021 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Many techniques have been developed to increase primary
stability of implants osseodensification is a new osteotomy technique for
enhancing bone density around implants and increasing primary stability Hence
the objective of the current in vivo study is to evaluate hard and soft tissue
changes around dental implants placed with osseodensification in contrast with
conventional osteotomy technique |