| CTRI Number |
CTRI/2024/09/073596 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
09/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Customized Dental Implants- A Prospective pilot clinical study. |
|
Scientific Title of Study
|
Customized Root Analogue Implants- A Prospective pilot 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 |
Parvinder Sharma |
| Designation |
Lt Col |
| Affiliation |
Army Dental Corps |
| Address |
Dental Department
INMAS, DRDO
Brig SK Mazumdar Road
Timarpur
Delhi
North
DELHI
110054
India |
| Phone |
8989505251 |
| Fax |
|
| Email |
sharmaparvinder@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Parvinder Sharma |
| Designation |
Lt Col |
| Affiliation |
Army Dental Corps |
| Address |
Dental Department
INMAS, DRDO
Brig SK Mazumdar Road
Timarpur
Delhi
North
DELHI
110054
India |
| Phone |
8989505251 |
| Fax |
|
| Email |
sharmaparvinder@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Parvinder Sharma |
| Designation |
Lt Col |
| Affiliation |
Army Dental Corps |
| Address |
Dental Department
INMAS, DRDO
Brig SK Mazumdar Road
Timarpur
Delhi
North
DELHI
110054
India |
| Phone |
8989505251 |
| Fax |
|
| Email |
sharmaparvinder@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional, Central Govt |
|
|
Primary Sponsor
|
| Name |
DRDO |
| Address |
Dental Department
INMAS, DRDO
Brig SK Mazumdar Road
Timarpur, Delhi
110054 |
| 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 |
| Dr Parvinder Sharma |
Army Dental Centre ,Research & Referral |
Room No OS-2
Department: Oral Surgery
Army Dental Centre (Research & Referral)
Near Dhaulakuan
New Delhi
New Delhi
DELHI |
8989505251
sharmaparvinder@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Human Ethical Committe , Army Dental Centre (RR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Customized Root Analogue Implant |
Cutomized root analogue implant of Titanium alloy (Ti6Al4V) will be used as intervention. Ten cases with non restorable single root tooth that needed to be extracted will be selected for the study. Root analogue implant will be designed using imaging data.Customized titanium Root analogue implant will be fabricated. Customized root analogue implant of titanium will be placed for the replacement of single root tooth. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
(i) Patients in need of immediate dental implant placement in tooth/teeth with single root
(ii) Individuals aged between 18-50 years
(iii) ASA-1 physical status (American Society of Anaesthesiologists)
(iv) Available for necessary post-operative follow up
(v) Adequate soft tissue health to obtain primary wound closure
|
|
| ExclusionCriteria |
| Details |
(i) Smokers
(ii) Uncontrolled diabetes/alcoholism
(iii) Uncontrolled periodontitis
(iv) Presence of purulent exudates at the time of extraction
(v) Adjacent soft tissue cellulites and granulation tissue
(vi) Presence of severe periodontal bone loss without purulent exudates
(vii) Root malformations which may prevent insertion of custom implants
(viii) Root length less than 10mm
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical and radiographical outcome evaluation of root analogue implant placed to replace single root tooth |
07 days, 01 month, 04 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| efficiency of imaging based 3D design technique used for designing of Root analogue Implant. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 3 |
|
Date of First Enrollment (India)
|
20/09/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Ten cases with non restorable single root tooth that needed to be extracted will be selected for the study. The data from the patient CT will be converted and 3D models will be generated. The virtual extraction procedure will be carried out in the model. Extraction socket will be evaluated and Root analogue implant will be designed. After the design analysis of the root analogue implant the customized implant will be fabricated in titanium. Provision for the prosthetic components will be provided in root analogue implant. The implant will be sterilized as per standard protocol. The Root Analogue Implant will be placed into the extraction socket after adequate debridement, curettage and irrigation. Clinical and radiographic outcomes (crestal bone loss) will be evaluated at baseline, 07 days, 01 month, 04 months after implant placement.. |