| 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
|
|
|
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
|
|
|
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 ml. The
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. |