| CTRI Number |
CTRI/2025/07/090576 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Joined vs. Separate Dental Implants: Which Lasts Longer and Works Better? |
|
Scientific Title of Study
|
Comparative evaluation of splinted and non-splinted abutments with variable connections.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K Anusha Ravindra |
| Designation |
Ph D Student |
| Affiliation |
Sri Siddhartha Dental College and Hospital |
| Address |
Room No.4,Department of Prosthodontics,Sri Siddhartha Dental College and Hospital, Agalakote B H Road,Tumakuru
Tumkur
KARNATAKA
572107
India |
| Phone |
9964155888 |
| Fax |
|
| Email |
anusharavindra5888@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Chowdhary |
| Designation |
Professor |
| Affiliation |
Sri Siddhartha Dental College and Hospital |
| Address |
Room No.4, Department of Prosthodontics, Sri Siddhartha Dental College and Hospital Agalakote B H Road Tumakuru
Tumkur
KARNATAKA
572107
India |
| Phone |
9845206898 |
| Fax |
|
| Email |
drramc@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramesh Chowdhary |
| Designation |
Professor |
| Affiliation |
Sri Siddhartha Dental College and Hospital |
| Address |
Room No.4, Department of Prosthodontics, Sri Siddhartha Dental College and Hospital Agalakote B H Road Tumakuru
Tumkur
KARNATAKA
572107
India |
| Phone |
9845206898 |
| Fax |
|
| Email |
drramc@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dr K Anusha Ravindra Sri Siddhartha Dental College and Hospital Sri Siddhartha Academy of Higher Education |
|
|
Primary Sponsor
|
| Name |
Dr K Anusha Ravindra |
| Address |
Sri Siddhartha Dental College, B H Road, Agalkote, Tumkur-572107 |
| 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 K Anusha Ravindra |
Sri Siddhartha Dental College and Hospital |
Room no.4, Department of Prosthodontics, Agalakote, B.H.Road
Tumkur
KARNATAKA |
9964155888
anusharavindra5888@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Siddhartha Dental College and Hospital Institutional Ethical Committee |
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 |
Nobel Biocare Spiral Implants |
Caparison between Step implant abutment connection (90 degree) and Morse taper implant abutment connection (11 degree) in both single and splinted implants in 80 cases. |
| Intervention |
Straumann TISLA Implants |
Caparison between Step implant abutment connection (90 degree) and Morse taper implant abutment connection (11 degree) in both single and splinted implants in 80 cases. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
participants with single or two mandibular posterior teeth missing and requiring implant treatment for the same
Participants should not have any contraindication for dental surgery
Participants must have sufficient bone quality and quantity for implant placement as determined by clinical and radiographic evaluations Sufficient bone height and width to place at least 10 mm length and 3.8 diameter Minimum inter arch space should be ideal 10-12 mm
Participants must be able to understand the study requirements and provide informed consent
|
|
| ExclusionCriteria |
| Details |
Participants with uncontrolled systemic diseases such as diabetes cardiovascular disease or immunodeficiency disorders
Heavy smokers more than 10 cigarettes per day or those unwilling to cease smoking during the study period
Participants currently on medications that could interfere with bone healing such as bisphosphonates or corticosteroids
Patients who were completely edentulous and wearing complete denture
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Stability |
Every 3 months for 2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| survival |
2 years |
| Peri implant bone loss |
2 years |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/01/2026 |
| 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="2"
Months="0"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- 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 who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [anusharavindra5888@gmail.com].
- For how long will this data be available start date provided 01-06-2026 and end date provided 01-06-2031?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This randomized clinical trial aims to compare the
stability, survival, and marginal bone loss of two implant abutment
connection Conical Hex Morse taper and Step butt joint in screw and
cement retained restorations. A total of 80 patients are divided into two
parts 40 with a single mandibular molar missing and 40 with two posterior
teeth missing. Each part has subgroups based on implant type and retention
method. Diagnostic records, CBCT, and intraoral scans are used for planning. A
delayed loading protocol is followed, with follow-up at 3, 6, 12, and 24
months. Bone loss is measured radiographically stability via ISQ values.
Statistical analysis will be done using SPSS with ANOVA Kruskal Wallis and
post hoc tests. The study aims to guide clinicians in selecting optimal
implant-abutment systems for long-term success. |