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CTRI Number  CTRI/2025/05/086419 [Registered on: 06/05/2025] Trial Registered Prospectively
Last Modified On: 30/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Measuring levels of plastics in oral fluid and deposits and comparing it to gum diseases  
Scientific Title of Study   Microplastics in saliva and oral biofilm and its association with periodontal disease: A Cross-Sectional study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
IEC2: 38/2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  K M Thousil 
Designation  First year Post graduate 
Affiliation  Manipal College of Dental Sciences,Manipal 
Address  Room no 3, Manipal College of Dental Sciences, Manipal Academy of Higher Education, Manipal,Udupi,Karnataka-576104 India

Udupi
KARNATAKA
574104
India 
Phone  7019885845  
Fax    
Email  thousil.mcodsmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aditi Chopra 
Designation  Asoociate Professor 
Affiliation  Manipal College of Dental Sciences,Manipal 
Address  Room no 3, Manipal College of Dental Sciences, Manipal Academy of Higher Education, Manipal,Udupi,Karnataka-576104 India

Udupi
KARNATAKA
574104
India 
Phone  7019885845  
Fax    
Email  aditi.chopra@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  K M Thousil 
Designation  First year Post graduate 
Affiliation  Manipal College of Dental Sciences,Manipal 
Address  Room no 3, Manipal College of Dental Sciences, Manipal Academy of Higher Education, Manipal,Udupi,Karnataka-576104 India India

Udupi
KARNATAKA
574104
India 
Phone  7019885845  
Fax    
Email  thousil.mcodsmpl2024@learner.manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Dental Sciences,,Madhav nagar,Manipal,Udupi,karnataka-574104 
 
Primary Sponsor  
Name  Manipal College of Dental Sciences Manipal 
Address  Manipal College of Dental Sciences, Manipal, Madhav Nagar, Udupi District, Karnataka, India, pin 576104 
Type of Sponsor  Research institution and hospital 
 
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 
K M Thousil  Manipal College of Dental Sciences, Manipal  Room no 3 ,Department of Periodontology, Manipal college of Dental Sciences,Manipal,Udupi-574104,Karnataka,India
Udupi
KARNATAKA 
7019885845

thousil.mcodsmpl2024@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics committee - 2(Students research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Gingival and Periodontal disease(Gum diseases) 
Patients  (1) ICD-10 Condition: B968||Other specified bacterial agents as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All genders and above 18 years of age 
 
ExclusionCriteria 
Details  Participants who are undergoing chemotherapy or radiation therapy.
Participants with any oral active infection requiring emergency treatment at the time of recruitment.
Mentally and physically impaired individuals.
Pregnant and lactating females
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) The levels of MPs in saliva and oral biofilm will be measured and correlate their levels with demographic and clinical parameters in patients with periodontal health and disease.
2) A comprehensive quantification and characterization of MPs in saliva and oral biofilm will be obtained.
 
Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Oral Hygiene Index; Plaque Index (Turesky Modification of the Quigley-Hein Plaque Index); Gingival Index (Loe and Silness, 1967); Percentage of sites with bleeding on probing to quantify the severity of gingival inflammation;Pocket depth, interdental papillary recession  Baseline 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   15/05/2025 
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)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Microplastics (MPs), synthetic polymers with particles <5 mm, can originate from primary sources like microbeads and secondary sources from the degradation of larger plastics. They can enter the body through inhalation, ingestion, and topical application. Recent studies have detected MPs in saliva, with significant implications for oral health, including their potential role in oral diseases and increased viscosity of saliva linked to higher MP concentrations. Few studies have found that the presence of MPs in saliva and sputum, with a concentration of MPs in saliva reported to the level of the total number of microplastics, was 39.5 particles/10 mlThe presence of MPs in saliva intrigues their role in oral diseases and the functions of saliva. Few pieces of evidence have reported that MPs increase the composition and rheological properties of saliva. For example, a study by Przekop et al found that the viscosity of saliva is high in individuals with high concentrations of MPs. MPs may also support biofilm formation and contribute to periodontal disease. Despite confirmed presence in various body parts, research on the quantity and effects of MPs in saliva and oral biofilms is limited. The proposed study aims to investigate the nature and abundance of MPs in oral biofilms, which will inform public health policies and raise awareness about the possible health risks associated with MPs, particularly concerning periodontal disease.

 
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