| CTRI Number |
CTRI/2025/05/087420 [Registered on: 22/05/2025] Trial Registered Prospectively |
| Last Modified On: |
02/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Two Types of Dental Implants to Assess Their Clinical and X-ray Outcomes |
|
Scientific Title of Study
|
Comparative Evaluation of Two Different Dental Implant Systems: A Clinico-Radiographic 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 Varili Syuhlo |
| Designation |
Post Graduate Student |
| Affiliation |
Himachal Institute of Dental Science, Dept. of Periodontics and Implantology Room no 4,Paonta Sahib, Himachal Pradesh |
| Address |
Himachal Institute of Dental Science, Dept. of Periodontics and Implantology Room no 4,Paonta Sahib, Himachal Pradesh
Sirmaur
HIMACHAL PRADESH
173025
India |
| Phone |
7018374800 |
| Fax |
|
| Email |
varilival23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parveen Dahiya |
| Designation |
Professor |
| Affiliation |
Himachal Institute of Dental Science, Dept. of Periodontics and Implantology Room no 4,Paonta Sahib, Himachal Pradesh |
| Address |
Himachal Institute of Dental Science, Dept. of Periodontics and Implantology Room no 4,Paonta Sahib, Himachal Pradesh
Sirmaur
HIMACHAL PRADESH
173025
India |
| Phone |
9857373300 |
| Fax |
|
| Email |
parveen_132@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parveen Dahiya |
| Designation |
Professor |
| Affiliation |
Himachal Institute of Dental Science, Dept. of Periodontics and Implantology Room no 4,Paonta Sahib, Himachal Pradesh |
| Address |
Himachal Institute of Dental Science, Dept. of Periodontics and Implantology Room no 4,Paonta Sahib, Himachal Pradesh
HIMACHAL PRADESH
173025
India |
| Phone |
9857373300 |
| Fax |
|
| Email |
parveen_132@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Himachal Institute of Dental Science, Dept. of Periodontics and Implantology Room no 4,Paonta Sahib, Himachal Pradesh, 173025, India |
|
|
Primary Sponsor
|
| Name |
Dr Varili Syuhlo |
| Address |
Himachal Institute of Dental Science, Dept. of Periodontics and Implantology Room no 4,Paonta Sahib, Himachal Pradesh |
| 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 Varili Syuhlo |
Himachal Institute Of Dental Science, Paonta Sahib |
Himachal Institute of Dental Science, Dept. of Periodontics and Implantology Room no 4,Paonta Sahib, Himachal Pradesh
Sirmaur
HIMACHAL PRADESH |
07018374800
varilival23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HIDS INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
edentulous area requiring implant placement |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Placement of dental implants using Implant System (OSSTEM) |
Placement of dental implants using the Osstem TS III system a tapered, SA-surfaced implant. Implant dimensions length will be selected according to clinical needs. Placement will follow standard protocols under local anesthesia, with prosthetic loading based on stability. Follow-up at 3months, 6 months and 12 months |
| Comparator Agent |
Placement of dental implants using Implant System(ADIN) |
Placement of dental implants using the ADIN Touareg™-S system a self-tapping, spiral implant. Implant dimensions will be selected based on bone availability. Implants will be placed under local anesthesia following standard surgical protocols. Prosthetic loading will be early or delayed depending on primary stability. Follow-up will be at 3 months, 6 months and 12 months. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient who are willing to comply with all the study related procedures after signing an informed consent form.
2.Both male and female patients aged 20 years and above.
3.Edentulous area requiring implant placement.
4.Non-contributing medical history.
5.Good oral hygiene.
|
|
| ExclusionCriteria |
| Details |
1.Poor oral hygiene
2.Osteogenesis related disorders
3.Taking medication that affect bone formation
4.Oral/Parental Rheumatic Druigs
5.Uncontrolled hypertension
6.Diabetes mellitus
7.Oral Mucosal Lesions
8.History of radiation therapy
9.Alchoholism
10.Severe bruxism or clenching
11.Pregnant/lactating women
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the peri-implant marginal bone level radiographically at baseline (time of implant placement), 3rd, 6th and 12th months after Implant placement. This will be done both for Adin and Osstem Implant systems.
|
3rd,6th and 12th months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare various clinical parameters around both the implant systems at 3rd,6th and 12th months. |
3rd,6th and 12th months. |
|
|
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)
|
30/05/2025 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is designed to clinically and radiographically compare two different dental implant systems ADIN and OSSTEM in edentulous patients. Eligible participants will recieve either ADIN or OSSTEM implants, placed using standard surgical protocols. Clinical outcomes such as implant probing depth, plaque index, gingival index, and bleeding index will be assist at defined intervals. Radiographic assessment will be performed to measure marginal bone level changes around the implants. The study aim to provide evidence on the comparative performance, success rate of the two implant systems to help guide clinical decision making. |