| CTRI Number |
CTRI/2026/01/101601 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
17/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Missing teeth or decayed teeth are replaced by dental implant , bone and gum response to two dental implant types will be evaluated |
|
Scientific Title of Study
|
Comparative Evaluation of Bone Level and Tissue Level Implants - A Clinico-Radiographic Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BFUHS/2k25/p-TH/21176 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sumit Arora |
| Designation |
MDS Student |
| Affiliation |
Sri Guru Ram Das Institute of Dental Sciences and Research |
| Address |
Room number - 3
Department of Periodontology
Sri Guru Ram Das Institute of Dental Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
9097600013 |
| Fax |
|
| Email |
sumitarora026@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sahib Tej Singh |
| Designation |
MDS |
| Affiliation |
Sri Guru Ram Das Institute of Dental Sciences and Research |
| Address |
Room number - 3
Department of Periodontology
Sri Guru Ram Das Institute of Dental Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
7589206060 |
| Fax |
|
| Email |
sahibtejsingh@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumit Arora |
| Designation |
MDS Student |
| Affiliation |
Sri Guru Ram Das Institute of Dental Sciences and Research |
| Address |
Room number - 3
Department of Periodontology
Sri Guru Ram Das Institute of Dental Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
9097600013 |
| Fax |
|
| Email |
sumitarora026@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Society of Periodontology |
| Sri Guru Ram Das Institute of Dental Sciences and Research, Mall Mandi, G.T, Road, Amritsar |
|
|
Primary Sponsor
|
| Name |
Indian Society of Periodontology |
| Address |
Dr. Ashish Jain,
Honorary Secretary,
ISP, #721, Phase 3B-1,
Mohali - 160059, India |
| Type of Sponsor |
Other [Academic society providing research funding and support in the field of Periodontology] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sri Guru Ram Das Institute of Dental Sciences and Research |
Mall mandi road, G.T. Road, Amritsar |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr SUMIT ARORA |
SRI GURU RAM DAS INSTITUTE OF DENTAL SCIENCES AND RESEARCH |
ROOM NUMBER 3, DEPARTMENT OF PERIODONTOLOGY
Amritsar
PUNJAB |
9097600013
sumitarora026@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
SINGLE TO MULTIPLE MISSING TEETH SHOULD BE PRESENT IN THE ORAL CAVITY |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
IMPLANT |
bone level type of implant |
| Comparator Agent |
Implant |
Tissue level type of implant |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy adults aged 18-80 years of age
2. Patients with missing teeth indicative of dental implants
3. Periodontally healthy patients |
|
| ExclusionCriteria |
| Details |
1. Patients having systemic disease influencing the periodontal health
2. Alcoholics, smokers, tobacco chewers, drug addicts
3. Pregnant woman and lactating mothers |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| MARGINAL BONE LOSS |
6 MONTHS
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PERI-IMPLANT PROBING DEPTH |
6 MONTHS |
| TISSUE THICKNESS |
6 MONTHS |
| HEALING INDEX |
2 WEEKS |
|
|
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)
|
30/01/2026 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - Proposals should be directed to [email ID to be provided
sumitarora026@gmail.com
- For how long will this data be available start date provided 31-01-2026 and end date provided 31-01-2033?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is a clinico-radiographic trial, 24 patients indicative of dental implants will be included in the study and are divided into two groups that is : Group A : Bone level implant placement Group B : Tissue level implant placement Primary outcome of the study is marginal bone evaluation at baseline and 6 months and other secondary parameters such as peri implant probing depth, tissue thickness and healing index will be evaluated. |