| CTRI Number |
CTRI/2026/01/101948 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Success in Tissue-Level and Bone-Level Dental Implants. |
|
Scientific Title of Study
|
Comparative evaluation of biologic, surgical and prosthetic success of Tissue level and bone level implants. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Thiyaneswaran Nesappan |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College |
| Address |
Department of Oral Implantology, Clinic 26, 5th Floor, 162, Poonamalle high road, Chennai, 600077
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9884176432 |
| Fax |
|
| Email |
dr.thiyan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Subhashree Rohinikumar |
| Designation |
Reader |
| Affiliation |
Saveetha Dental College |
| Address |
Department of Oral Implantology, Clinic 26, 5th floor, 162, Poonamalle high road, Chennai, 600077
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9790741570 |
| Fax |
|
| Email |
subhashreer.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Sahana Selvaganesh |
| Designation |
Assistant professor |
| Affiliation |
Saveetha Dental College |
| Address |
Department of Oral Implantology, Clinic 26, 5th Floor, 162, Poonamalle high road, Chennai, 600077
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9444964693 |
| Fax |
|
| Email |
sahanas.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College and Dentium implants |
|
|
Primary Sponsor
|
| Name |
Dentium implants |
| Address |
8th Main road, 3rd block, jakasandra block, Koramangala 3 block, Koramangala, Bengaluru, Karnataka 560034 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
| DrThiyaneswaran |
Saveetha Dental College |
Department of Oral Implantology, Clinic 26, 5th floor, 62, Poonamallee High Road,. Chennai - 600077. Tamil Nadu. India.
Thiruvallur
TAMIL NADU |
9884176432
said@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review board - Saveetha Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No systemic conditions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bone level implants |
Dentium Implants |
| Comparator Agent |
Tissue level implants |
Dentium implants |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
No systemically compromised individuals |
|
| ExclusionCriteria |
| Details |
Patients under medications and chronic systemic conditions, Auto immune disorders |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bleeding on probing, Bone loss, Primary and secondary stability, Bacterial adhesion, Soft tissue health and soft tissue adaptation, Fit of the prosthesis |
Baseline, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Bleeding on probing,tissue adaptation, Fit of the prosthesis |
1 week, 3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
16/02/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 choice between tissue-level (TL) and bone-level (BL) implants is dictated by a trade-off between biological stability and aesthetic flexibility. Tissue-level implants excel in the posterior regions due to their "one-stage" surgical protocol and a built-in transmucosal collar that shifts the implant-abutment interface away from the bone, effectively reducing crestal bone resorption and simplifying hygiene maintenance. Conversely, bone-level implants are the gold standard for the aesthetic zone, as their submerged placement allows for precise control over the emergence profile and soft-tissue contouring. While both systems demonstrate comparable high survival rates, TL implants offer superior protection against peri-implantitis via a machined smooth surface, whereas BL implants provide the surgical versatility required for complex grafting and high-demand anterior restorations. |