| CTRI Number |
CTRI/2025/07/090704 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing professional opinions and patient feedback on cone-shaped versus hexagon-shaped dental implant connections |
|
Scientific Title of Study
|
Professional and patient reported outcome measures in conical vs internal hexagon implant-abutment connection: A randomized controlled trial |
| 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 Koushika R |
| Designation |
Academic Junior resident |
| Affiliation |
Faculty of Dental Sciences, Banaras Hindu University |
| Address |
Unit of Periodontology
Faculty of Dental Sciences
Institute of Medical Sciences
Banaras Hindu University
Trauma center campus
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9787916774 |
| Fax |
|
| Email |
koushir1112@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monika Bansal |
| Designation |
Professor |
| Affiliation |
Faculty of Dental Sciences, Banaras Hindu University |
| Address |
Unit of Periodontology
Faculty of Dental Sciences
Institute of Medical Sciences
Banaras Hindu University
Trauma center campus
Balaji nagar,Bhagwanpur
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9335499117 |
| Fax |
|
| Email |
drmonika97@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Koushika R |
| Designation |
Academic Junior resident |
| Affiliation |
Faculty of Dental Sciences, Banaras Hindu University |
| Address |
Unit of Periodontology
Faculty of Dental Sciences
Institute of Medical Sciences
Banaras Hindu University
Trauma center campus
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9787916774 |
| Fax |
|
| Email |
koushir1112@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of Dental Sciences
Institute of Medical Sciences
Trauma Centre Campus
Banaras Hindu University
Varanasi-221005
Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
KoushikaR |
| Address |
Unit Of Periodontology, Faculty Of Dental Sciences, IMS, BHU,
Varanasi-221005, UP |
| Type of Sponsor |
Other [Koushika.R] |
|
|
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 KoushikaR |
Faculty of Dental Sciences ,Institute of Medical Sciences, Banaras Hindu University |
Room no.5, Unit Of
Periodontology, Faculty
Of Dental Sciences,
Institute of Medical Sciences
Banaras Hindu University
Trauma centre campus,Balaji nagar,Bhagwanpur,Varanasi-221005,Uttar Pradesh
Varanasi
UTTAR PRADESH |
9787916774
koushir1112@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
single/multiple edentulous sites
(anterior/posterior maxilla or mandible) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Implants with conical abutment connection |
Implants with conical abutment connection will be placed in maxilla or mandible.Professional outcome measures such as implant survival,crestal bone level, biologic complications,prosthetic complications will be evaluated.Implant survival and prosthetic complications will be evaluated 6 months after prosthesis delivery. Crestal bone level will be measured at the time of implant placement,4 months after implant placement and 6 months after prosthesis delivery. Biologic complications will be evaluated after implant placement and after prosthesis delivery. Patient reported outcome measures like comfort,masticatory function,speech,esthetics and overall satisfaction will be evaluated after the prosthesis delivery and at 6 months |
| Comparator Agent |
Implants with internal hexagon abutment connection |
Implants with internal hexagon abutment connection will be placed in maxilla or mandible.Professional outcome measures such as implant survival,crestal bone level, biologic complications,prosthetic complications will be evaluated.Implant survival and prosthetic complications will be evaluated 6 months after prosthesis delivery.Crestal bone level will be measured at the time of implant placement,4 months after implant placement and 6 months after prosthesis delivery.Biologic complications will be evaluated after implant placement and after prosthesis delivery.Patient reported outcome measures like comfort,masticatory function,speech,esthetics and overall satisfaction will be evaluated after the prosthesis delivery and at 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Individuals of both genders, aged 18 to 65 years
Physically and mentally healthy individuals
Individuals willing to participate in the study
Single/Multiple missing teeth in the maxilla or mandible
Periodontally healthy individuals with periodontal probing depth less than 3mm
Individuals with good plaque control and demonstrating good compliance
Individuals with a favourable and stable occlusal relationship
|
|
| ExclusionCriteria |
| Details |
Individuals with systemic illness, osteoporosis, bleeding disorders and similar conditions
Pregnant and lactating women
Individuals with a history of smoking or using smokeless tobacco
Individuals with a history of drug or alcohol abuse
Individuals with a history of allergy
Individuals with an immunocompromised condition or debilitating disease
Individuals who have undergone radiotherapy or chemotherapy for malignancy
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Professional reported outcomes:Implant survival,Crestal bone level, Biologic complications,Prosthetic complications,Analysis of inflammatory markerS(if feasible)
Patient reported outcomes:Comfort,Masticatory function,Speech,Esthetics,Overall satisfaction |
Professional outcome measures such as implant survival,prosthetic complications will be evaluated at 6 months after prosthesis delivery.Crestal bone level will be evaluated at the time of implant placement,4 months after implant placement and 6 months after prosthesis delivery.Biologic complications will be evaluated after implant placement and after prosthesis delivery.Patient reported outcome measures such as comfort,masticatory function,speech,esthetics and overall satisfaction will be evaluated after the delivery of prosthesis and at 6 months after delivery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
18/08/2025 |
| 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="8"
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
|
Oral implantology is an advancing field with the continuous development of new designs, concepts and materials. Currently, dental implants have various abutment connections designed to reduce the risk of abutment movement and loosening of the inner screws. There are several types of internal connections, with most commonly being the internal hex and conical designs. Professional outcome measures such as implant survival, crestal bone level, biologic complications, prosthetic complications and Patient reported outcome measures such as comfort, masticatory function, speech, esthetics and overall satisfaction will be evaluated in conical vs internal hexagon implant abutment connection.
|