| CTRI Number |
CTRI/2025/06/089283 [Registered on: 23/06/2025] Trial Registered Prospectively |
| Last Modified On: |
20/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two types of implant hex connections and there effect on crestal bone levels. |
|
Scientific Title of Study
|
Comparative evaluation of crestal bone levels as influenced by two different implant connections- An in-vivo 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. Rajshree Singh |
| Designation |
Post graduate student |
| Affiliation |
INSTITUTE OF DENTAL STUDIES AND TECHNOLOGIES |
| Address |
Department of prosthodontics and crown & bridge
Institute of dental studies and technologies
Kadrabad
Modinagar
Uttar pradesh
201201
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
8076065773 |
| Fax |
|
| Email |
rajshrees0408@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Pallavi Sirana |
| Designation |
Professor |
| Affiliation |
INSTITUTE OF DENTAL STUDIES AND TECHNOLOGIES |
| Address |
Department of prosthodontics and crown & bridge
Institute of dental studies and technologies
Kadrabad
Modinagar
Uttar pradesh
201201
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9582388501 |
| Fax |
|
| Email |
dr.pallavisirana@idst.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Pallavi Sirana |
| Designation |
Professor |
| Affiliation |
INSTITUTE OF DENTAL STUDIES AND TECHNOLOGIES |
| Address |
Department of prosthodontics and crown & bridge
Institute of dental studies and technologies
Kadrabad
Modinagar
Uttar pradesh
201201
UTTAR PRADESH
201201
India |
| Phone |
9582388501 |
| Fax |
|
| Email |
dr.pallavisirana@idst.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of prosthodontics and crown & bridge
Institute of dental studies and technologies
Kadrabad
Modinagar
Uttar pradesh
201201
MODINAGAR
UTTAR PRADESH
201201 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
Dr. Rajshree Singh
Institute of dental studies and technologies
Department of prosthodontics and crown & bridge
Kadrabad
Modinagar
Uttar pradesh
201201 |
| Type of Sponsor |
Other [Private dental 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 |
| Dr Rajshree Singh |
Institute of Dental studies & technologies |
Kadrabad, Modinagar
Ghaziabad
UTTAR PRADESH |
8076065773
rajshrees0408@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IDST ETHICS COMMITTE |
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 |
Adin closefit implant system |
conical implant abutment connection for 6 months |
| Intervention |
Adin touarag S |
internal hex implant abutment connection for 6 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Good oral hygiene
Partially edentulous sites
Adequate amount of bone width & height
|
|
| ExclusionCriteria |
| Details |
Parafunctional habits
chronic smokers
pregnant women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| prosthetic rehabilitation of partially edentulous mandibular arch |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| crestal bone level |
6 months |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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)
|
15/07/2025 |
| 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="8"
Days="25" |
|
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
|
The study conducted will help
in evaluating the implant hex connections and their effect on crestal bone
levels and the better connection with reduced micro gap thus, maintaining the
crestal bone levels. Evaluating the crestal bone levels using digital radiography. |