CTRI

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CTRI Number

CTRI/2025/08/092427 [Registered on: 05/08/2025] Trial Registered Prospectively

Last Modified On:

04/08/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Dentistry

Study Design

Non-randomized, Multiple Arm Trial

Public Title of Study

Exploring the Effects of Gum Treatment on Iron and Inflammation in the Body

Scientific Title of Study

ESTIMATION OF THE EFFECT OF NONSURGICAL PERIODONTAL THERAPY ON HEPCIDIN, INFLAMMATORY AND IRON MARKER LEVELS AN INTERVENTIONAl STUDY

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Putta Uday Simha
Designation	MDS
Affiliation	NITTE University
Address	A B Shetty Memorial Institute of Dental Sciences NITTE ( Deemed to be University),Department of Periodontology ,4th floor, Derlakatte, Mangaluru - 575018 Dakshina Kannada KARNATAKA 575018 India
Phone	7095874501
Fax
Email	udaysimha19@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Rahul bhandary
Designation	professor
Affiliation	NITTE University
Address	A B Shetty Memorial Institute of Dental Sciences NITTE ( Deemed to be University),Department of Periodontology ,4th floor, Derlakatte, Mangaluru - 575018 Dakshina Kannada KARNATAKA 575018 India
Phone	9845583085
Fax
Email	bhandaryrahul@gmail.com

Details of Contact Person
Public Query

Name	Putta Uday Simha
Designation	MDS
Affiliation	NITTE University
Address	A B Shetty Memorial Institute of Dental Sciences NITTE ( Deemed to be University),Department of Periodontology ,4th floor, Derlakatte, Mangaluru - 575018 Dakshina Kannada KARNATAKA 575018 India
Phone	7095874501
Fax
Email	udaysimha19@gmail.com

Source of Monetary or Material Support

A B SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES A Constituent College of Nitte (Deemed to be University) Deralakatte, Mangalore –575018

Primary Sponsor

Name	NIL
Address	NIL
Type of Sponsor	Other [NIL]

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
Putta Uday Simha	A B Shetty memorial institute of dental sciences	NITTE ( Deemed to be University),Department of Periodontology ,4th floor, Derlakatte, Mangaluru - 575018 Dakshina Kannada KARNATAKA	7095874501 udaysimha19@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethical committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	not applicable

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Non-Surgical Periodontal Therapy	it involves scaling with ultrasonic scalers and root planing with area-specific Gracey curettes, aiming to remove the granulation tissue, which aids in decreasing inflammation. stage 2 periodontitis.
Intervention	Non-Surgical Periodontal Therapy	it involves scaling with ultrasonic scalers and root planing with area-specific Gracey curettes, aiming to remove the granulation tissue, which aids in decreasing inflammation. stage 3 periodontitis.

Inclusion Criteria

Age From	30.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1. 30-65 years of age. 2. Patients with only periodontitis and with no other systemic diseases. 3. Patients with no tooth loss; CAL 1 to 4 mm; PD less than or equal to 5 mm will be considered as Group 1, less than or equal to 5 teeth lost due to periodontitis, CAL greater than or equal to 5 mm, and PD greater than or equal to 6mm will be considered as Group 2.

ExclusionCriteria

Details

1. Pregnant and lactating women.
2. Systemically compromised patients.
3. No past history of smoking.
4. Patients under antibiotic drug therapy.
5. Patients under orthodontic treatment.
6. Patients with a history of steroid and nonsteroidal anti-inflammatory drugs.
7. Patients undergoing iron replacement therapy for anemia.
8. Patients who underwent subgingival scaling and periodontal surgery at least 6 months prior.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
1. serum hepcidin 2. pro-inflammatory cytokines : IL-1Beta, hs-CRP, ESR 3. iron markers : Serum iron, transferrin saturation receptor, ferritin	20 days

Secondary Outcome

Outcome	TimePoints
nil	nil

Target Sample Size

Total Sample Size="58"
Sample Size from India="58"
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)

18/08/2025

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="1"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

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

Periodontitis is defined as an inflammatory disease of the supporting tissues of teeth caused by specific microorganisms or groups of specific microorganisms, resulting in progressive destruction of the periodontal ligament and alveolar bone with periodontal pocket formation, gingival recession or both.

Gram negative bacteria such as Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola and Aggregatibacter actinomycetemcomitans play a significant role in the pathogenesis of chronic periodontitis. In conditions like chronic periodontitis associated with gram-negative bacteria porphyromonas gingivalis, Tannerella forsythia, Treponema denticola cause an imbalance towards pro inflammatory immune response and results in release of Interleukin1Beta, Interleukin 6 and Tumor necrosis factor Alpha.

Inflammatory cytokines such as Interleukin1Beta, Interleukin 6 and Tumor necrosis factor Alpha.

have seen to be increased in patients with chronic periodontitis and also in systemic diseases, it underlines a bidirectional link between chronic periodontitis and other chronic diseases.

Body iron load and inflammatory cytokines regulate the production of hepcidin, reflecting the association of this hormone with inflammatory disorders.

In a previous study, it was observed that successful Periodontal therapy results in a decrease in the serum levels of prohepcidin in patients with Chronic periodontitis with chronic kidney disease group or without chronic kidney disease control group

It has been postulated that periodontal therapy, both supragingival and subgingival scaling and root planning, may reduce serum Interleukin 6 and hepcidin levels, thereby reinforcing the positive effects of periodontal care on systemic health. Therefore, this interventional study is designed to evaluate the effect of non-surgical periodontal therapy on levels of serum hepcidin, inflammatory markers, and iron markers.

AIM

To estimate the effect of non-surgical periodontal therapy on levels of serum hepcidin, inflammatory markers, and iron markers among chronic periodontitis patients.

OBJECTIVES

1. To estimate Baseline values of serum hepcidin, pro inflammatory cytokines Interleukin, Interleukin 6 and Serum iron in healthy individuals with stage 2 and stage 3 periodontitis according to 2017 classification.

2. To evaluate and compare the effectiveness of scaling and root planning after a duration of 20 days follow up on serum hepcidin, pro inflammatory cytokines Interleukin 1, Interleukin 6 and Serum iron among stage 2 and stage 3 periodontitis according to 2017 classification.