FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/03/064899 [Registered on: 28/03/2024] Trial Registered Prospectively
Last Modified On: 25/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the impact of two different designs of dental implants on how stable they are when used in a procedure where they are immediately loaded for function. 
Scientific Title of Study   Evaluation of the Effect of Two Different Implant Thread Designs on Implant Stability in Immediate Functional Loading Protocol - A Randomized Control 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  Janvi Kalra 
Designation  Post Graduate Student 
Affiliation  Manav Rachna Dental College 
Address  Manav Rachna Dental College, Faridabad, Department of Prosthodontics and Crown and Bridge and Implantology, Room No. 6, 1st Floor, Q-block

Faridabad
HARYANA
121004
India 
Phone  7023227279  
Fax    
Email  janvikalra1999@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Pankaj Dhawan 
Designation  Professor and HOD 
Affiliation  Manav Rachna International institute of Research and Studies 
Address  Manav Rachna Dental College, Faridabad

Faridabad
HARYANA
121004
India 
Phone  9810050104  
Fax    
Email  dhawan.sds@mrei.ac.in  
 
Details of Contact Person
Public Query  
Name  Janvi Kalra 
Designation  Post Graduate Student 
Affiliation  Manav Rachna Dental College 
Address  Manav Rachna Dental College, Faridabad, Department of Prosthodontics and Crown and Bridge and Implantology, Room no.6, 1st Floor, Q-block


HARYANA
121004
India 
Phone  7023227279  
Fax    
Email  janvikalra1999@gmail.com  
 
Source of Monetary or Material Support  
Self, Manav Rachna Dental college, Faridabad, Department of Prosthodontics, Room no. 6, Q-block 
 
Primary Sponsor  
Name  Janvi Kalra 
Address  Manav Rachna Dental College, Faridabad, Haryana 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Janvi Kalra  Manav Rachna International Institute of Research and Studies  Manav Rachna Dental College, Department of Prosthodontics, Room no. 6, 1st floor, Q-block
Faridabad
HARYANA 		 7023227279

janvikalra1999@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Partially edentulous patients 
Patients  (1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, (2) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Neodent Implants  Implants with trapezoidal thread design, 6 month follow up trial 
Comparator Agent  ReFirm implants  A newly introduced implant system with dynamic thread design, 6 month follow up trial 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Patients presenting with single missing posterior tooth in mandibular arch.
Patients within the age group of 20-45 years of either sex.
Patients with D2 bone quality (850-1250 Hounsfield Units).
Patients with Insertion Torque value ≥ 30 Ncm at baseline.
Patients with sufficient vertical inter arch space to accommodate the prosthetic component.
 
 
ExclusionCriteria 
Details  Patients having known history of bone disorders (e.g. osteoporosis, osteoarthritis).
Patients having known systemic diseases contraindicated for implant placement.
Patients with a history of smoking.
Patients with a history of drug intake such as immunosuppressive drugs, anticoagulants and anti-cancer drugs three months prior to the study.
Patients undergoing orthodontic treatment.
Pregnant and lactating women. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To evaluate implant stability quotient in Dynamic Progressive implant thread design (Neodent® Helix GM® Implants) in functionally loaded implants at baseline, 3 months and 6 months post-loading.
To evaluate implant stability quotient in Optimized implant thread design (IntEssence Refirm® Implants) in functionally loaded implants at baseline, 3 months and 6 months post-loading.
To compare the implant stability quotient values obtained in Dynamic Progressive implant thread design and Optimized implant thread design in functionally loaded implants at baseline, 3 months and 6 months post-loading.
 		 baseline, 3 months, 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
N/A  N/A 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/04/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. 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.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [janvikalra1999@gmail.com].

  6. For how long will this data be available start date provided 31-10-2025 and end date provided 31-10-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

·       Implant dentistry has evolved from the conventional healing protocol of 3–6 months to the most recent trends of immediate and early loading of implants.

·       Good implant stability is fundamental to the success of immediate functional loading.

·       Primary stability of the dental implant is achieved through a good mechanical fixation of the dental implant within the bone, whereas secondary stability is achieved due to biological integration.

·       Implants with varying characteristics and macro-geometry show different biomechanical behaviours, which lead to differences in the stability of the implant.

·       It is necessary to understand the individual response of each implant thread design in terms of primary and secondary stability.

·       During the early phases of healing, the micromovements of the implant should not exceed values ranging between 50 and 150 µm for predictable osseointegration.

·       These values can be observed by methods such as Periotest, Insertion Torque, Resonance Frequency Analysis and Radiography.

·       The purpose of this study is to compare implant stability using Immediate functional loading protocol in two implant systems with different thread designs.

 
Close