| 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 |
|
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Primary Sponsor
|
| Name |
Sarah Mariam |
| Address |
Bharati vidyapeeth dental college and hospital |
| Type of Sponsor |
Other [self ] |
|
|
Details of Secondary Sponsor
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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, |
|
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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.
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
Alternation |
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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 |
|
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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
|
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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. |