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CTRI Number  CTRI/2023/01/049252 [Registered on: 27/01/2023] Trial Registered Prospectively
Last Modified On: 06/01/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial to study microbial growth following placement of different sealing materials in dental implants  
Scientific Title of Study   Microbial assessment & quantification following placement of different sealing materials at the screw abutment connection under loading conditions in dental implants A metagenomic study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  sarah mariam 
Designation  Assistant Professor 
Affiliation  Bharati vidyapeeth deemed to be university dental college and hospital, Pune 
Address  Bharati vidyapeeth deemed to be university dental college and hospital, Pune

Pune
MAHARASHTRA
411030
India 
Phone    
Fax    
Email  sarah.mariam@bharatividyapeeth.edu  
 
Details of Contact Person
Scientific Query
 
Name  sarah mariam 
Designation  Assistant Professor 
Affiliation  Bharati vidyapeeth deemed to be university dental college and hospital, Pune 
Address  Bharati vidyapeeth deemed to be university dental college and hospital, Pune

Pune
MAHARASHTRA
411030
India 
Phone    
Fax    
Email  sarah.mariam@bharatividyapeeth.edu  
 
Details of Contact Person
Public Query
 
Name  sarah mariam 
Designation  Assistant Professor 
Affiliation  Bharati vidyapeeth deemed to be university dental college and hospital, Pune 
Address  Bharati vidyapeeth deemed to be university dental college and hospital, Pune

Pune
MAHARASHTRA
411030
India 
Phone    
Fax    
Email  sarah.mariam@bharatividyapeeth.edu  
 
Source of Monetary or Material Support  
Bharati vidyapeeth deemed to be university dental college and hospital, Pune , Maharashtra 
Biokart India private limited, 1st floor, 401-4AB cross ,East of NGEF, Bengaluru - 560043  
 
Primary Sponsor  
Name  Sarah Mariam 
Address  Bharati vidyapeeth dental college and hospital 
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 
Sarah Mariam  Bharati vidyapeeth dental college and hospital  Ground floor, Room number 03, Department of Periodontology
Pune
MAHARASHTRA 
9540068535

sarah.mariam@bharatividyapeeth.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Bharati Vidyapeeth, Pune (India)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, (2) ICD-10 Condition: K081||Complete loss of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  around the collar of dental implant  oral swab will be collected from and around the implant fixture to serve as control. duration 3 months 
Intervention  light body putty  light body putty material to be placed in implant abutment connection for duration of 03 months 
Intervention  Polytetraflouroethylene tape  PTFE tape to be placed in implant abutment connection for duration of 03 months. 
Intervention  Temporary composite material   temporary composite material to be inserted in implant abutment connection for duration of 03 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Immediate implant placement or delayed implant placement in adult population more than 18 years of age for both gender.
2. Edentulism in mandibular molar area.
3. B and B implant system to be used in the study.
4. Abutment type - internal hexagon connection.
5. Screw retained prosthesis with access hole.
 
 
ExclusionCriteria 
Details  1. Other implant system.
2. Abutment type other than internal hexagon connection.
3. Cement retained prosthesis.
4. Patient suffering from any uncontrolled systemic condition
5. Patient suffering from active periodontal disease, or if patient has undergone any periodontal treatment in past 06 months.

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Immediate
i. Material which contains largest quantity of oral microbes can be avoided since it can affect the success rate of implants.
ii. Metagenomic study can help us know specific microbial niches which form part of specific materials.
Long term
i. Since the success rate of implant is 90% for 10 years and 80% for next 10 years IMPLANT MAINTENANCE is important.
ii. The present study is clinically relevant as changing material at screw-abutment connection forms an important protocol in follow up.
iii. The best material which supports the least microbiome forms part of long term expected outcomes.
 
Recruitment-one year
Metagenomic analysis- two years 
 
Secondary Outcome  
Outcome  TimePoints 
Long term
i. Since the success rate of implant is 90% for 10 years and 80% for next 10 years IMPLANT MAINTENANCE is important.
ii. The present study is clinically relevant as changing material at screw-abutment connection forms an important protocol in follow up.
iii. The best material which supports the least microbiome forms part of long term expected outcomes.
 
Recruitment- one year
Metagenomic analysis: 02 year
secondary outcomes: 1 year 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   N/A 
Date of First Enrollment (India)   01/02/2023 
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="6"
Days="10" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   No publication yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The leakage of microorganisms and fluids to the inner parts of the implants is considerably increased by load application, which generates micro-movements and interfacial gaps. (Khraisat et al., 2006). Bacterial species harboring the internal surfaces of the implants and components is not surprising, since the size of oral bacterial species ranges in average from 1.1 to 1.5 μm in length and 2 to 6 μm in diameter. Smaller species like spirochetes (diameter of 0.1 to 0.5 μm) may also be found in the oral microbiota. (Jansen et al., 1997).

Micro gaps between implant and abutment are generally less than 10 um. Given access to the microgap, bacteria can easily penetrate even through the tightest implant-abutment fittings. Biofilms and bacterial colonization of dental implants. According to Quirynen et al. (2002), gaps in the implant-abutment interface may act as a trap for bacteria, favoring the development of biofilm with varying composition and impact on periodontal tissues. AA, T forsythia and P gingivalis, many times present in these biofilms, are pathogens intimately related to the development and maintenance of periodontitis and peri-implantitis. Considering the increased use of dental implants and recognizing the impact of bacterial leakage along the implant-abutment interface on the health of peri-implant tissues this study was planned.

 

ABOUT METAGENOMICS-The next culture-independent game changer

 


Recently, metagenomics was defined as "the application of modern genomics techniques to the study of communities of microbial organisms directly in their natural environments, bypassing the need for isolation and lab cultivation of individual species".

There is no defined consensus among implantologists’ with regard to what is ideal material when it comes to
sealing the implant abutment connection. More so, very few studies have been undertaken under loading
conditions. Different variation of materials have been taken, some new types (e.g. temporary composite
material) to find the best possible combination. This study was therefore planned to reduce the ambiguity with
regard to this very important clinical parameter under loading conditions. Since microbes comprise the primary
factor with regard to implant failure, determining specific microbial niches is of paramount importance and this
study will help us find specific microbial niches (identification and quantification) which can exist with regard
to different sealing agents placed in implant abutment screw hole. Also, swab will be taken around the implant
fixture before placement of abutment as that will act as the control group. So this study was planned to include
highly specific and advanced technique of metagenomics for all cases of implant placement three months after
loading using different sealing materials in implant abutment screw hole.
 
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