| CTRI Number |
CTRI/2024/09/073448 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
02/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of dental Implant positioning outcomes between computer-supported implant placement surgical procedures |
|
Scientific Title of Study
|
Comparative Evaluation of Immediate Implant Placement
Position in Coronal, Apical and Angular Directions using
Dyanamic Navigation and Static Surgical Guide-A Clinical
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 Sirisha Sadupati |
| Designation |
Post Graduate student |
| Affiliation |
Vishnu Dental College. |
| Address |
Department Of Prosthodontics And Crown And Bridge,PG-8,Block-2
Vishnu Dental College,
Bhimavaram.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
7680050901 |
| Fax |
|
| Email |
sirisha.sadupati10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D Bheemalingeswara Rao |
| Designation |
Professor and Head of the Department |
| Affiliation |
Vishnu Dental College |
| Address |
Department Of Prosthodontics And Crown And Bridge,PG-8, Block-2
Vishnu Dental College,
Bhimavaram.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9701008765 |
| Fax |
|
| Email |
bheemalingeswararao.d@vdc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr D Bheemalingeswara Rao |
| Designation |
Professor and Head of the Department |
| Affiliation |
Vishnu Dental College |
| Address |
Department Of Prosthodontics And Crown And Bridge,PG-8, Block-2
Vishnu Dental College,
Bhimavaram.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9701008765 |
| Fax |
|
| Email |
bheemalingeswararao.d@vdc.edu.in |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College, Vishnupur, West Godavari District, Andhra Pradesh, India
Bhimavaram.534202 |
|
|
Primary Sponsor
|
| Name |
Dr Sirisha Sadupati |
| Address |
Postgraduate Student,
Department Of Prosthodontics,PG-8,Block-2
Vishnu Dental College,
Vishnupur,Bhimavaram,
West Godavari District,
Andhra Pradesh-534202.
|
| 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 Sirisha Sadaupati |
Vishnu Dental College, |
Department Of Prosthodontics,PG-8, Block-2,
Vishnu Dental College,
Vishnupur,Bhimavaram,
534202.
West Godavari
ANDHRA PRADESH |
7680050901
sirisha.sadupati10@gmail.com |
|
|
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: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Immediate Implant of 4 x 13 mm size Placement
using Dyanamic Navigation System. |
Extraction of teeth will be done atraumatically with piezo tips. Following sequential drilling, an implant of 4 x 13 mm size will be placed immediately using the dynamic navigation system of version 3.0 software |
| Comparator Agent |
Immediate Implant of 4 x 13 mm size Placement using Static Surgical Guide. |
Extraction of teeth atraumatically with piezo tips. Following the sequential drilling, a 4 x 13 mm size implant will be placed immediately using the static surgical guide, which is prepared with 3shape implant studio software. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of age between 20-50 years.
2.Single-rooted maxillary teeth.
3.ASA I II
4.Intact buccal and palatal cortical plate.
5.Tooth indicated for extraction. |
|
| ExclusionCriteria |
| Details |
1.Limited mouth opening
2. Teeth with Active periapical infections.
3. Poor oral compliance and Chronic smokers.
4.ASA III,IV, V
5. Patients subjected to radiotherapy to the head and neck. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of immediate implant placement position in Coronal, Apical and Angular Directions |
Baseline |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
13/09/2024 |
| 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="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Achieving precise
implant placement is a primary concern in implantology,
particularly in aesthetic regions. Dynamic navigation, a computer-assisted
method, enables surgeons to monitor the three-dimensional positions of their
instruments in real-time during implant site preparation. Additionally,
3D-printed surgical guides are used for immediate single implant placement after
extraction. This study presents an alternative approach for post-extraction
implant placement using computer-assisted implant surgery, which can improve
the accuracy of implant positioning and enhance long-term functional and
aesthetic results. This current study will aim to evaluate the immediate
implant position in coronal, apical and angular directions using a Dynamic
Navigation System and Static surgical guide and To compare immediate implant
deviation in coronal, apical and angular directions using a Dynamic Navigation
and Static Surgical Guide.
This study will include
samples of 24 regular-diameter implants divided into two groups: group 1
immediate implant placement using Dynamic Navigation and group 2 immediate
implant placement using a static surgical guide. The accuracy was measured by
calculating the deviation between real implant position obtained from cone beam
computed tomography CBCT and the planned implant position |