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CTRI Number  CTRI/2024/10/075009 [Registered on: 09/10/2024] Trial Registered Prospectively
Last Modified On: 03/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological
Medical Device
Surgical/Anesthesia
Dentistry 
Study Design  Other 
Public Title of Study   Evaluation of healing of dental implants at microscopic level in dental patients 
Scientific Title of Study   Post Surgical Comparison of expression of Biomarkers in Gingival crevicular fluid and blood for dental implant patients for assessment of wound healing 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sayantan Bhattacharya 
Designation  Postgraduate Trainee (OMFS) 
Affiliation  Thaimoogambigai Dental College and Hospital 
Address  Department of oral and Maxillofacial Surgery, Thaimoogambigai Dental College and Hospital, Gangai Amman Koil St, Golden George Nagar, Mogappair, Chennai, Tamil Nadu

Chennai
TAMIL NADU
600107
India 
Phone  7044217097  
Fax    
Email  sayantanbhattacharya21@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Pradeep Christopher Jesudas 
Designation  Head of The Department 
Affiliation  Thaimoogambigai Dental College and Hospital 
Address  Department of oral and Maxillofacial Surgery, Thaimoogambigai Dental College and Hospital, Gangai Amman Koil St, Golden George Nagar, Mogappair, Chennai, Tamil Nadu

Chennai
TAMIL NADU
600107
India 
Phone  7044217097  
Fax    
Email  pradeepchris68@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sayantan Bhattacharya 
Designation  Postgraduate Trainee (OMFS) 
Affiliation  Thaimoogambigai Dental College and Hospital 
Address  Department of Oral and Maxillofacial Surgery, Thaimoogambigai Dental College and Hospital, Gangai Amman Koil St, Golden George Nagar, Mogappair, Chennai, Tamil Nadu

Chennai
TAMIL NADU
600107
India 
Phone  7044217097  
Fax    
Email  sayantanbhattacharya21@gmail.com  
 
Source of Monetary or Material Support  
Thaimoogambigai Dental College and Hospital,Golden George Nagar,Mogappair Chennai - 600 107 Tamil Nadu, India Phone: 044-26533178  
 
Primary Sponsor  
Name  Sayantan Bhattacharya 
Address  Gangai Amman Koil St, Golden George Nagar, Mogappair, Chennai, Tamil Nadu 
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 Sayantan Bhattacharya  Thaimoogambigai Dental College and Hospital  Department of oral and maxillofacial Surgery,Gangai Amman Koil St, Golden George Nagar, Mogappair, Chennai, Tamil Nadu
Chennai
TAMIL NADU 		 7044217097

sayantanbhattacharya21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL COMMITTEE OF THAIMOOGAMBIGAI DENTAL COLLEGE AND HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: Z736||Limitation of activities due to disability,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  therapeutic Intervention (dental implants) for checking biomarkers  Intervention on 1st day, follow up at 1 week and 1 month, post operatively 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  -Adult patients (18 years or older) who are willing for dental implant surgery

-Sufficient bone density and quality for implant placement, confirmed by radiographic examination.

-Participants willing to adhere to follow-up visits and sample collection procedures 
 
ExclusionCriteria 
Details  -Patients with Active systemic diseases (uncontrolled diabetes, autoimmune diseases).

-Recent antibiotic or anti-inflammatory therapy within the past 4 weeks.

-History of deleterious habits (smoking/chewing tobacco, consumption of alcohol).

-Signs of active infection or complications at the implant site.

-Pregnancy or breastfeeding.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Expression of genes  at baseline, 1 week, 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   12/11/2024 
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="2"
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 - 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 [sayantanbhattacharya21@gmail.com].

  6. For how long will this data be available start date provided 14-12-2026 and end date provided 14-12-2028?
    Response - Immediately following publication. No end date.

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

This study investigates expression of biomarkers in Gingival Crevicular fluid (GCF) and Blood to not only assess healing progress but also inform about the prognosis of the procedure in a non-invasive way. By analyzing and comparing specific biomarkers i.e. IL(A), IL(B) and TNF(A) in both GCF and blood, this study aims to establish reliable indicators of successful healing after placement of dental implant This prospective cohort study investigates the association between GCF (gingival Crevicular fluid) biomarkers and peri-implant health in adult patients who have undergone dental implant surgery. For which sample Size is Thirty (30) adult patients to be recruited at Thaimoogambigai Dental College and Hospital, Chennai, India. GCF will be collected from peri-implant sites using standardized protocols. and the collected GCF will be analysed for specific biomarkers using appropriate equipment (armamentarium) for biomarker analysis.

 

 
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