| CTRI Number |
CTRI/2024/03/064613 [Registered on: 21/03/2024] Trial Registered Prospectively |
| Last Modified On: |
18/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Human Jaw Bone drilling using 2 techniques for dental implant placement |
|
Scientific Title of Study
|
Osseodensification vs Piezo Assisted Osseodensification: A Randomized clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Renganath Murugan Jeyasree |
| Designation |
Assistant Professor |
| Affiliation |
Rajas Dental College and Hospital |
| Address |
Assistant Professor, Department of Periodontics and Implantology, Rajas Dental College and Hospital, Kavalkinaru Jn, Tirunelveli Dt, Tamil Nadu, India.
Kancheepuram
TAMIL NADU
627105
India |
| Phone |
9488833355 |
| Fax |
|
| Email |
renganatharjun@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Renganath Murugan Jeyasree |
| Designation |
Assistant Professor |
| Affiliation |
Rajas Dental College and Hospital |
| Address |
Assistant Professor, Department of Periodontics and Implantology, Rajas Dental College and Hospital, Kavalkinaru Jn, Tirunelveli Dt, Tamil Nadu, India.
TAMIL NADU
627105
India |
| Phone |
9488833355 |
| Fax |
|
| Email |
renganatharjun@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Renganath Murugan Jeyasree |
| Designation |
Assistant Professor |
| Affiliation |
Rajas Dental College and Hospital |
| Address |
Assistant Professor, Department of Periodontics and Implantology, Rajas Dental College and Hospital, Kavalkinaru Jn, Tirunelveli Dt, Tamil Nadu, India.
TAMIL NADU
627105
India |
| Phone |
9488833355 |
| Fax |
|
| Email |
renganatharjun@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajas Dental college and hospital, Kavalkinaru Junction, Tirunelveli- 627105 |
|
|
Primary Sponsor
|
| Name |
Rajas Dental College and Hospital |
| Address |
Department of Periodontics and Implantology, Kavalkinaru Jn, Tirunelveli Dt, Tamil Nadu, India.627105 |
| Type of Sponsor |
Private medical 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 |
| Renganath Murugan Jeyasree |
Rajas dental college and Hospital |
No 6, Department of Periodontics and Implantology,
Tirunelveli
TAMIL NADU |
9488833355
renganatharjun@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K063||Horizontal alveolar bone loss, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Osseodensification |
Osteotomy prepared using Densah drills(osseodensification) with sequential osteotomy |
| Intervention |
Piezo Assisted Osseodensification |
Osteotomy preparation performed using Piezosurgery by 2 vertical releasing incisions and then sequential osteotomy using densification drills |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Severely atrophic isolated maxillary ridge
Cawood-Howell class 4 classification |
|
| ExclusionCriteria |
| Details |
Patients with systemic diseases like diabetes mellitus, cardiac problems. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Piezoelectric surgery assisted split and osseodensification may exhibit stable crestal bone levels compared to osseodensification protocol where an apparent level of bone loss may be found
|
CBCT will be assessed on Baseline, 4 months and 18 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/04/2024 |
| 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
|
Introduction:
Dental implant treatment for replacing missing teeth has become very common.
However, periodontal disease could also be a reason for tooth loss which leads
to deficient bony architecture. Implant placement in such situations becomes
possible by bone augmentation procedures like ridge split, bone expansion.
Aim:
The aim of the present study is to compare and evaluate the marginal bone level around dental implants placed using osseodensification alone with that of Piezo
assisted osseodensification in severely atrophied ridge.
Materials
and methods: 32 patients with severely atrophied
single or multiple edentulous areas in maxillary arch who are willing for
dental implant placement will be included in the study. Patients will be categorized
into 2 groups. Group A: implant placement using osseodensification protocol with
contour grafting. Group B: implant placement using piezo assisted
osseodensification protocol with grafting on jumping space. All the implants
will be placed at equi-crestal level. Follow up CBCTs will be taken for all the
patients to evaluate peri-implant bone levels after 18 months of implant
placement. |