| CTRI Number |
CTRI/2023/11/059576 [Registered on: 06/11/2023] Trial Registered Prospectively |
| Last Modified On: |
15/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study on the upper jaw treatment with dental implant placement either with free hand or with real-time guiding equipment |
|
Scientific Title of Study
|
Accuracy of Dental Implant Placement with Indirect Sinus Lift via Dynamic Navigation or the Freehand Method: A Split Mouth Randomized Controlled 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 |
Satyanarayana Raju Mantena |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Prosthodontics and Implantology,
Vishnu Dental College,
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9492293809 |
| Fax |
|
| Email |
satya@vdc.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Satyanarayana Raju Mantena |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Prosthodontics and Implantology,
Vishnu Dental College,
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9492293809 |
| Fax |
|
| Email |
satya@vdc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Satyanarayana Raju Mantena |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Prosthodontics and Implantology,
Vishnu Dental College,
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9492293809 |
| Fax |
|
| Email |
satya@vdc.edu.in |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College, Bhimavaram |
|
|
Primary Sponsor
|
| Name |
Dr. YSR University of Health Sciences |
| Address |
Near Siddhartha Medical College, Beside New Government General Hospital, near Ramavarappadu, Vijayawada, Andhra Pradesh 520008 |
| Type of Sponsor |
Other [Health University] |
|
|
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 |
| DrSatyanarayana Raju M |
Vishnu Dental College |
Department of Implantology, Room no.7, Block 2, Vishnupur
West Godavari
ANDHRA PRADESH |
08816250893
satya@vdc.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Vishnu Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Free hand Implant Placement |
Dental implant placement by conventional Free hand method in the edentulous alveolar ridge of maxilla.Implant orientation is measured immediately after placement using evalunav software |
| Intervention |
Dynamic navigation system |
Dental implant placement in the edentulous maxilla using Dynamic Navigation System, Navident, Claronav. Implant orientation is measured immediately after placement using evalunav software |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Posterior maxilla with sinus pneumatisation with residual bone height of 4mm or above.
2. ASA I patients |
|
| ExclusionCriteria |
| Details |
1. Existing sinus pathology
2. Acute or Chronic pathology in the site of implant placement
3. Patient with smoking and para functional habits |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Accuracy of implant placement in vertical, horizontal and angular orientations. |
1.At baseline- the accuracy of implant placement in vertical, horizontal and angular orientations will be measured |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
13/11/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The study aims to assess the accuracy of implant placement in vertical, horizontal, and angular orientation. We will compare and assess the accuracy of Implant placement in indirect sinus lift using dynamic navigation and free-hand placement in patients with edentulous areas in the maxillary posterior region with mild sinus pneumatization. |