| CTRI Number |
CTRI/2025/02/080543 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
31/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Salivary biomarker comparison among healthy gingiva, periodontitis with and without habit of smoking |
|
Scientific Title of Study
|
Comparison of salivary ph, alkaline phosphatase, lectate dehydrogenase, amylase, calcium, sodium and magnesium among healthy gingiva, periodontitis with and without smoking |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krunal Parmar |
| Designation |
Resident Doctor MDS (Periodontology) |
| Affiliation |
Faculty of Dental sciences, Dharmsinh Desai University |
| Address |
Department of periodontology, Faculty of Dental sciences, Dharmsinh Desai University, Nadiad, Gujarat
Kheda
GUJARAT
387001
India |
| Phone |
7284805611 |
| Fax |
|
| Email |
dr.krunalperio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vasumati Patel |
| Designation |
Head of the Department |
| Affiliation |
Dharmsinh Desai University |
| Address |
Department of periodontology, Dharmsinh Desai University,
Faculty of Dental science, College Road, Nadiad, Gujarat 387001
Kheda
GUJARAT
387001
India |
| Phone |
8200210769 |
| Fax |
|
| Email |
pateldrvasu@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krunal Parmar |
| Designation |
Resident Doctor MDS (Periodontology) |
| Affiliation |
Faculty of Dental sciences, Dharmsinh Desai University |
| Address |
Department of periodontolgy, Faculty of Dental sciences, Dharmsinh Desai University, Nadiad, Gujarat
Kheda
GUJARAT
387001
India |
| Phone |
7284805611 |
| Fax |
|
| Email |
dr.krunalperio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of periodontology,
Faculty of Dental science, Dharmsinh Desai University, College Road, Nadiad, Gujarat 387001 |
|
|
Primary Sponsor
|
| Name |
Dharmsinh Desai University |
| Address |
Dharmsinh Desai University, Faculty of Dental sciences, Nadiad, Gujarat 387001 |
| 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 |
| Dr Krunal Parmar |
Dharmsinh Desai University |
Department of Periodontology, Faculty of Dental Science, College Road, Nadiad, Gujarat 387001
Kheda
GUJARAT |
07284805611
dr.krunalperio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical committee of Faculty of Dental science, Dharmsinh Desai University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Healthy Individuals |
The subjects will be asked to rinse thoroughly with distilled water before the collection of saliva. Five minutes after the oral rinse the subjects will be asked to swallow any residual saliva and will be refrained from talking and were asked to drop down the head and will be then asked to let the unstimulated saliva pool in their floor of the mouth to their maximum extent and then spit into the container till the desired 5 ml quantity will be obtained. The pH of saliva will be determined immediately using pH meter (Konvio Neer) after the collection to avoid any time related pH changes following which the saliva samples will be transported to the laboratory for estimation within 1-2 hours using standard gel coolant pack in order to maintain the temperature between 2 ºC to 4 ºC. Then scaling and root planing will be performed and oral hygiene instructions will be given. Then patients will be recalled after 1 month after scaling and root planing for saliva collection to evaluate the salivary biomarkers. |
| Comparator Agent |
Nonsmokers with Periodontitis |
The subjects will be asked to rinse thoroughly with distilled water before the collection of saliva. Five minutes after the oral rinse the subjects will be asked to swallow any residual saliva and will be refrained from talking and were asked to drop down the head and will be then asked to let the unstimulated saliva pool in their floor of the mouth to their maximum extent and then spit into the container till the desired 5 ml quantity will be obtained. The pH of saliva will be determined immediately using pH meter (Konvio Neer) after the collection to avoid any time related pH changes following which the saliva samples will be transported to the laboratory for estimation within 1-2 hours using standard gel coolant pack in order to maintain the temperature between 2 ºC to 4 ºC. Then scaling and root planing will be performed and oral hygiene instructions will be given. Then patients will be recalled after 1 month after scaling and root planing for saliva collection to evaluate the salivary biomarkers. |
| Intervention |
Smokers with Periodontitis |
The subjects will be asked to rinse thoroughly with distilled water before the collection of saliva. Five minutes after the oral rinse the subjects will be asked to swallow any residual saliva and will be refrained from talking and were asked to drop down the head and will be then asked to let the unstimulated saliva pool in their floor of the mouth to their maximum extent and then spit into the container till the desired 5 ml quantity will be obtained. The pH of saliva will be determined immediately using pH meter (Konvio Neer) after the collection to avoid any time related pH changes following which the saliva samples will be transported to the laboratory for estimation within 1-2 hours using standard gel coolant pack in order to maintain the temperature between 2 ºC to 4 ºC. Then scaling and root planing will be performed and oral hygiene instructions will be given. Then patients will be recalled after 1 month after scaling and root planing for saliva collection to evaluate the salivary biomarkers. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group between 18 – 60 years.
2. Minimum 15 natural teeth should be present in dental arch excluding 3rd molar.
3. The periodontally healthy individuals will be selected on the basis of probing depth of less than equal to 3mm, with no radiographic evidence of alveolar bone loss and attachment loss and no bleeding on probing.
4. Generalised periodontitis individuals who has consumed more than five cigarettes a day since past 5 years will be selected on the basis of probing depth of greater than equal to 5mm with a minimum of eight teeth, clinical attachment loss with or without bleeding on probing and having moderate bone loss on an ortho-pantomogram (OPG).
5. Generalised periodontitis individuals who has never smoke any cigarettes will be selected on the basis of probing depth of grater than equal to 5mm with a minimum of eight teeth, clinical attachment loss with or without bleeding on probing and having moderate bone loss on an ortho-pantomogram (OPG). |
|
| ExclusionCriteria |
| Details |
1. Other form of tobacco users.
2. Smokers who have quite the habit of smoking in the last 6 months.
3. History of hospitalization or intake of medications in last 6 months.
4. Previous history of periodontal therapy in last 6 months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Salivary Biomarkers- Salivary pH, alkaline phosphatase, lactate dehydrogenase, amylase, calcium, sodium and magnesium |
Baseline, and 1 Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Probing Depth, Plaque Index, Gingival Index, Clinical Attachment Level |
Baseline and 1 Month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/02/2025 |
| Date of Study Completion (India) |
30/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/05/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.krunalperio@gmail.com].
- For how long will this data be available start date provided 20-09-2025 and end date provided 20-09-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
This study shall compare the salivary biomarkers among healthy gingiva, periodontitis with and without habit of smoking. It will be conducted as a clinical trial involving 60 patients with healthy gingiva, periodontitis with and without habit of smoking who meet the specified inclusion criteria. Various biochemical investigations including salivary pH, alkaline phosphatase, lactate dehydrogenase, amylase, calcium, sodium and magnesium levels among healthy gingiva, periodontitis with and without habit of smoking will be recorded at baseline and 1 month. The research aims to evaluate and compare the levels of salivary pH, alkaline phosphatase, lactate dehydrogenase, amylase, calcium, sodium and magnesium levels among healthy gingiva, periodontitis with and without habit of smoking. This salivary biomarkers will act as diagnostic biomarkers for estimating level of inflammatory diseases. The findings will contribute to improving clinical decision making and providing dentists with evidence based recommendations for treatment planning. |