FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/09/073478 [Registered on: 05/09/2024] Trial Registered Prospectively
Last Modified On: 04/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   How iron and alkaline phosphatase levels change in normal denture wearers compared to those who wear dentures supported by implants 
Scientific Title of Study   Biological Variation of Iron, Total Iron Binding Capacity & Alkaline Phosphatase in Completely Edentulous Patients Rehabilitated with Conventional Complete Denture, and Implant Supported Overdenture Patients – A Clinical Study 
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 Bharath B Nandan 
Designation  Post-graduate Student  
Affiliation  Manav Rachna dental College and Hospital 
Address  Room number 6, Department of Prosthodontics and Crown & Bridge, Manav Rachna Dental College, Faridabad

Faridabad
HARYANA
121004
India 
Phone  01294268800  
Fax    
Email  bharathbnandan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sapna Rani 
Designation  Professor 
Affiliation  Manav Rachna International Institute of Research and Studies 
Address  Room number 6, Department of Prosthodontics and Crown & Bridge, Manav Rachna Dental College

Faridabad
HARYANA
121004
India 
Phone  08375899663  
Fax    
Email  sapnarani.sds@mrei.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Sapna Rani 
Designation  Professor 
Affiliation  Manav Rachna dental College and Hospital 
Address  Room number 6, Department of Prosthodontics and Crown & Bridge, Manav Rachna Dental College, Faridabad

Faridabad
HARYANA
121004
India 
Phone  8375899663  
Fax    
Email  sapnarani.mrdc@mrei.ac.in  
 
Source of Monetary or Material Support  
Manav Rachna Dental College and Hospital 
 
Primary Sponsor  
Name  Bharath B Nandan 
Address  Room number 6, Department of Prosthodontics and Crown & Bridge, Manav Rachna Dental College, Faridabad 
Type of Sponsor  Other [Self funded] 
 
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 Bharath  Manav Rachna Dental College, Faridabad  Room number 6, Department of Prosthodontics and Crown & Bridge ,
Faridabad
HARYANA 		 09353687670

bharathbnandan@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  Completely edentulous patients 
Patients  (1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Implant supported overdentures in the mandibular arch   Implant supported overdentures in the mandibular arch at and d position and complete removable denture in the maxillary arch 
Comparator Agent  Serum ion TIBC ALP  Comparison in the level of Serum ion,TIBC,ALP in three groups  
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. For Dentate Patients: No missing teeth / if missing -rehabilitated with fixed prosthetics
2. Completely edentulous patients
3. No systemic diseases present
4.Adequate bone volume and quality to accommodate implants
5. Cooperative patient, willing for Implant overdenture surgical procedures, prostheticrehabilitation, and proper follow up 
 
ExclusionCriteria 
Details  1. Patients having known history of systemic diseases
2. Patients on iron and calcium supplements
3. Patients with history of smoking
4. Patients with insufficient bone quality and quantity and vertical inter arch space to accommodate the prosthetic component.
5. Patients who are not able to maintain their oral hygiene.
6. Patients with history of drug intake like immunosuppressive drugs, anti-coagulants and anti-cancer drugs three months prior to the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
There might be increase in serum iron, Total iron binding capicity and alkaline phosphatse in patients rehabilated with implant supported overdenture as compared to patients with conventional complete denture   To evaluate and compare the biological variation of iron, total iron binding capacity& alkaline phosphatase in dentate patients, completely edentulous patients rehabilitated with conventional complete denture and mandibular implant supported overdenture patients at insertion day and follow up after 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
not applicable   not applicable 
 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   16/09/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

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

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 (Others) - 

  6. For how long will this data be available start date provided 19-12-2024 and end date provided 19-02-2025?
    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 - None
Brief Summary  
AIM:

The aim of this clinical study is to observe the biological variation of serum iron, total iron binding capacity and alkaline phosphatase in completely edentulous patients rehabilitated with conventional complete denture and implant supported overdenture patients

Methodology:

The patients will be divided into three groups :

Group 1 - Dentate Patient  (Control Group)
Group 2 - Conventional Complete Denture Patients
Group 3 - Implant Overdenture Patients
•The Modified Kuppuswamy scale will be used for determining the socio-economic status of the individuals and thereby form groups : , “upper class, upper middle class, lower middle class, upper lower and lower socio-economic class
Dentate patients with natural dentition and/or prosthetically rehabilitated dentition will be selected
•Blood samples will be drawn after taking informed consent and patients who are wiling to participate in the study and willing to get the analysis of their biochemical parameters done will be recruited , and test will be done for serum iron, TIBC and ALP and levels are recorded
•Patients will be assessed and evaluated for conventional complete denture prosthetic rehabilitation
•The patient should be completely edentulous for a span of atleast three months before his/her visit to the department
•1st Sample Collection : Blood samples will be drawn, and test will be done for serum iron, TIBC and ALP and levels are recorded prior to delivery of conventional complete denture 
•Fabrication of conventional complete denture , follow up done after 24 hrs, 48hrs, 1week 15 days and 1 month
•Once patient is satisfied with the complete denture
•Usage of denture by patient for three months 
•2nd Sample Collection : Blood samples will be drawn, and test will be done for serum iron, TIBC and ALP and levels are recorded after the patient has been using the denture for three months 

Group 3 :

•Patients will be assessed and evaluated for implant overdenture prosthetic rehabilitation
•The patient should be completely edentulous for atleast a span of three months before his/her visit to the department
ʉۢ1st Sample Collection: Blood samples will be drawn, and test will be done for serum iron, TIBC and ALP and levels are recorded prior to delivery of implant overdenture
•Preimplant phase: fabricate stent on B and D position
•Surgical phase of implant placement
•2nd stage surgery – uncovery of implant after a waiting period of three months
•Complete denture fabrication and pickup for Implant overdenture attachments
•Patient using the Implant overdenture for a period of 3 months
•2nd Sample Collection: Blood samples will be drawn, and test will be done for serum iron, TIBC and ALP and levels are recorded after the patient has been using the denture for three months 
 
Close