| CTRI Number |
CTRI/2023/05/052587 [Registered on: 12/05/2023] Trial Registered Prospectively |
| Last Modified On: |
11/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the correctness of 3D printed and conventionally prepared surgical guide in implant
placement in bilateral lower back teeth region |
|
Scientific Title of Study
|
Comparison of the accuracy of implant placed with 3D printed surgical guide and with
conventionally prepared surgical guide:Split mouth
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jyoti Kutum |
| Designation |
Junior resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no. 210, 2nd floor, CDER division, Department of
Prosthodontics, AIIMS, New delhi 110029
South
DELHI
110029
India
South West
DELHI
110029
India |
| Phone |
7637916558 |
| Fax |
|
| Email |
jackkutum@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Veena Jain |
| Designation |
Head of the Department |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no. 209, 2nd floor, CDER Division, Department of
Prosthodontics, AIIMS, New Delhi
South
DELHI
110029
India
South West
DELHI
110029
India |
| Phone |
9868187441 |
| Fax |
|
| Email |
jainveena1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Veena Jain |
| Designation |
Head of the Department |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no. 209, 2nd floor, CDER Division, Department of
Prosthodontics, AIIMS, New Delhi
South
DELHI
110029
India
South West
DELHI
110029
India |
| Phone |
9868187441 |
| Fax |
|
| Email |
jainveena1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jyoti kutum, Junior resident, room no:210,2 nd floor,Department of prosthodontics, CDER
division, AIIMS,New delhi |
|
|
Primary Sponsor
|
| Name |
Jyoti Kutum |
| Address |
Room no 210,2 nd floor,Department of prosthodontics, CDER
division, AIIMS,New delhi
|
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| CDER AIIMS |
2nd floor, room no. 230, Department of Prosthodontics |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Jyoti Kutum |
AIIMS New Delhi |
2nd floor, Room no.
213 CDER division,
department of
Prosthodontics
South West
DELHI |
7637916558
jackkutum@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee, AIIMS, New delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Partially edentulous mandible |
| Patients |
(1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
3D printed surgical guide |
Evaluation of accuracy provided
by 3D printed guide in dental
implant placement after 6 months. . |
| Comparator Agent |
Conventional resin based
surgical guide.
|
Evaluation of accuracy of
implant placement using
conventional surgical guide after 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Individual with adequate bone height and width after extraction and
extraction completed at least 3 months prior to implant placement
and also should have antagonist teeth present. |
|
| ExclusionCriteria |
| Details |
Individual with metabolic and systemic disease, history of irradiation
in head and neck region, current alcohol or drug abuse, pregnancy
or lactating mother and poor oral hygiene |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparison of accuracy of implant placed with
3D printed guide and conventional guide |
At 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Compare the difference in implant planning by
conventional and digital method |
Six months after first CBCT |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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)
|
15/05/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/05/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="5" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [jackkutum@gmail.com].
- For how long will this data be available start date provided 12-02-2024 and end date provided 12-02-2040?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a randomized controlled trial using a split-mouth design comparing the accuracy
provided by 3-D printed surgical guide and conventionally prepared surgical guide in implant
placement. The primary outcome measure will the amount of deviation of the final implant position
from the planned position. |