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CTRI Number  CTRI/2022/04/041780 [Registered on: 11/04/2022] Trial Registered Prospectively
Last Modified On: 09/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic
Surgical/Anesthesia
Preventive
Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Surface change in tooth replacement implant to have long term success 
Scientific Title of Study   Effect of Guided probiotic colonization of dental implants on clinical outcomes, early healing dynamics and long-term success through immune-regulation: a randomized controlled trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rameshwari Singhal 
Designation  Additional Professor 
Affiliation  King Georges Medical University 
Address  room no.10 5th floor New OPD Building KGMC Shah Mina Rd Chowk Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  9837400562  
Fax    
Email  rameshwarisinghal@kgmcindia.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Rameshwari Singhal 
Designation  Additional Professor 
Affiliation  King Georges Medical University 
Address  room no.10 5th floor New OPD Building KGMC Shah Mina Rd Chowk Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  9837400562  
Fax    
Email  rameshwarisinghal@kgmcindia.edu  
 
Details of Contact Person
Public Query  
Name  Dr Rameshwari Singhal 
Designation  Additional Professor 
Affiliation  King Georges Medical University 
Address  room no.10 5th floor New OPD Building KGMC Shah Mina Rd Chowk Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  9837400562  
Fax    
Email  rameshwarisinghal@kgmcindia.edu  
 
Source of Monetary or Material Support  
Core Research Grant, SERB 
 
Primary Sponsor  
Name  core reseach grant by SERB 
Address  Science and Engineering Research Board 3rd & 4th Floor, Block II, Technology Bhawan, New Mehrauli Road New Delhi - 110 016 
Type of Sponsor  Government funding agency 
 
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 Rameshwari Singhal  King Georges Medical University, Lucknow  Department of Periodontology, 5th Floor, New Dental building, Faculty of Dental Sciences, KGMU
Lucknow
UTTAR PRADESH 		 919837400562

rameshwarisinghal@kgmcindia.edu 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
King Georges Medical University UP Lucknow Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Guided Probiotic Colonization of Dental Implants  Dental Implants modified by culturing Lactobacillus reutari (probiotic) on its surface will be placed in the test subjects and healing dynamics will be studied for 6 months  
Comparator Agent  Non modified Dental Implants  Dental Implants non modified by culturing Lactobacillus reutari (probiotic) on its surface will be placed in the control subjects and healing dynamics will be studied for 6 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  good general health
non smokers or former smokers(not smoked within 6 months of study initiation)
no chronic systemic diseases
presence of hopeless teeth requiring extraction
more than 3mm of bone beyond the root apex
presence of four bony walls of the socket with or without dehiscence 
 
ExclusionCriteria 
Details  presence of chronic systemic diseases
bruxism habit
uncontrolled diabetes
coagulation disorders
alcohol or drug abuse
reduced compliance after oral hygiene sessions
complete edentulism
mucosal diseases
pregnancy or lactation
patients withholding consent for participation in the study 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Early Wound Healing Dynamics by measuring following clinical parameters
Modified plaque index Mobelli et al 1987
Modified sulcus bleeding index Muhlemann and son 1971
Probing pocket depth by UNC 15 probe
Mucosa level
Resonance frequency analysis by Osstell instrument
Wound healing index by Wachtel et al 2003 and patient related outcomes by 5 point Likert type scale
Osseointegration by crestal bone loss by long cone parallel technique
Immune-regulation by M1 M2 cytokine profiling by ProcartaPlex
 		 from day 0 i.e 1st patient enrollment 1 3 6 12 months for most of the parameters. RFA is done at 0 3 14 21 28th day after implant placement than 3 6 12 months and PICF samples collected at 0 3 14 21 28th days after implant placement  
 
Secondary Outcome  
Outcome  TimePoints 
Study the long-term effect of GPC integrated implant in maintaining peri-implant disease free status compared to control group  Supportive implant maintenance protocol and would be evaluated for clinical and radiographical parameters at an interval of every 06 months after study completion. The long term-evaluation of implant survival, MBL and biological complications for at least 5 years after study completion 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   20/04/2022 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 none 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 Purpose: This Randomized controlled trial will be conducted to evaluate the effectiveness of Bio-modification of dental implant surface through guided probiotic colonization (GPC) on clinical and radiographical outcomes, early wound healing dynamics, and osseointegration by modulating the M1 and M2 immune response in the periodontal extraction sites.
Methods: 50 participants will be selected according to inclusion and exclusion criteria. Informed consent will be taken and they will be divided into 2 groups. for the test group, GPC-modified implants will be placed immediately post-extraction and for the control group normal unaltered implants will be placed immediately post-extraction. Then clinical, radiographical, patient-related, and immunological parameters will be measured and recorded on time for both groups for final analysis.
Results: Analysis of 2 groups will be done by unpaired t test, for more than 2 groups ANOVA followed by Turkey’s post-hoc test and Newmann keuls post-hoc test by graph pad prism will be performed. Spearmann rank correlation test will be done to find a correlation between immune expressions and clinical parameters. 
 
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