CTRI

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CTRI Number

CTRI/2026/04/107822 [Registered on: 07/04/2026] Trial Registered Prospectively

Last Modified On:

20/02/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Diagnostic
Screening
Dentistry

Study Design

Non-randomized, Active Controlled Trial

Public Title of Study

A study to see whether treating severe gum disease can help lower blood pressure, reduce inflammation, and improve cholesterol levels in people who already have high blood pressure

Scientific Title of Study

EFFECT OF PERIODONTAL THERAPY ON BLOOD PRESSURE LEVELS,SERUM C-REACTIVE PROTEIN AND LIPID PROFILE IN HYPERTENSIVE PATIENTS WITH STAGE III PERIODONTITIS-A CLINICO HEMATOLOGICAL 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	DrSwathi S Malagatti
Designation	post graduate student
Affiliation	COORG INSTITUTE OF DENTAL SCIENCES
Address	Coorg institute of dental sciences ,department of Periodontics and Implantology,room no 4 ,KK campus,Maggula village,Virajpet,District-Kodagu Kodagu KARNATAKA 571218 India
Phone	9108057410
Fax
Email	swathimalagatti@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Amit Walvekar
Designation	HOD
Affiliation	COORG INSTITUTE OF DENTAL SCIENCES
Address	Coorg institute of dental sciences ,Department of Periodontics and Implantology,Room no 4,K K campus ,Maggula village,Virajpet-571218,Karnataka,Kodagu,India Kodagu KARNATAKA 571218 India
Phone	9480085687
Fax
Email	amitakw@rediffmail.com

Details of Contact Person
Public Query

Name	DrSwathi S Malagatti
Designation	post graduate student
Affiliation	COORG INSTITUTE OF DENTAL SCIENCES
Address	Coorg institute of dental sciences ,Department of Periodontics and Implantology,room no 4,K K campus ,Maggula village,Virajpet-571218,Karnataka,Kodagu,India Kodagu KARNATAKA 571218 India
Phone	9108057410
Fax
Email	swathimalagatti@gmail.com

Source of Monetary or Material Support

COORG INSTITUTE OF DENTAL SCIENCES,DEPARTMENT OF PERIODONTICS AND IMPLANTOLOGY,KANJITHANDA KUSHALAPPA CAMPUS,MAGGULA VILLAGE,VIRAJPET-571218,KODAGU,KARNATAKA

Primary Sponsor

Name	Dr SWATHI S MALAGATTI
Address	COORG INSTITUTE OF DENTAL SCIENCES,DEPARTMENT OF PERIODONTICS AND IMPLANTOLOGY,KANJITHANDA KUSHALAPPA CAMPUS,MAGGULA VILLAGE,VIRAJPET-571218,KODAGU,KARNATAKA
Type of Sponsor	Other [Self]

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
DrSwathi S Malagatti	Coorg institute of dental sciences	Coorg institute of dental sciences ,Department of Periodontics and implantology,Room no 4,K K campus ,Maggula village,Virajpet-571218,Karnataka,Kodagu,India Kodagu KARNATAKA	09108057410 swathimalagatti@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
INSTITUTIONAL REVIEW BOARD,COORG INSTITUTE OF DENTAL SCIENCES	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: K053\|\|Chronic periodontitis,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	not applicable	not applicable
Intervention	scaling and root planing followed by flap surgery	Scaling and root planing will be performed to eliminate subgingival plaque and calculus, thereby reducing periodontal inflammation. Patients with residual pockets will subsequently undergo periodontal flap surgery to achieve further pocket reduction and improve periodontal health

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1) Patients of age more than 18 years 2) Patients with known hypertension 3) Patients with stage III Periodontitis (probing depth greater than or equal to 6mm) 4) Patients with radiographic evidence of bone loss

ExclusionCriteria

Details

(1) active infectious diseases, such as hepatitis, HIV, or tuberculosis,
(2) pregnant or breastfeeding, and
(3) taking nonsteroidal anti-inflammatory drugs on a regular basis or taking antibiotics within 3 months of assessment.
(4) Smokers

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome

TimePoints

1) To evaluate the efficacy of non surgical periodontal therapy(scaling and root planing) and surgical therapy on clinical parameters,blood pressure,serum crp and lipid profile in hypertensive patients with stageIII periodontitis.
2) 3) To compare the effect of surgical and non surgical periodontal treatment on clinical parameters,blood pressure,serum crp and lipid profile in hypertensive patients with Stage III periodontitis.

assessed at baseline,2 weeks and 3 months

Secondary Outcome

Outcome

TimePoints

1) To evaluate the efficacy of non surgical periodontal therapy(scaling and root planing) on clinical parameters,blood pressure,serum crp and lipid profile in hypertensive patients with stageIII periodontitis.
2) To evaluate the efficacy of surgical therapy on clinical parameters,blood pressure,serum crp and lipid profile in hypertensive patients with Stage III periodontitis.
3) To compare the effect of surgical and non surgical periodontal treatment on clinical parameters,blood pressure,serum crp and lipid profile in hypertensive patients with Stage III periodontitis.

At the baseline a detailed case history, clinical parameters which includes plaque index (PI), Gingival Index (GI), Bleeding on probing (BOP), clinical attachment loss (CAL) and Probing pocket depth (PPD) will be recorded and blood samples will be collected for detection of c reactive protein levels and lipid profile and blood pressure to be recorded.The same is followed at 2 weeks after SRP and 3 months after flap surgery

Target Sample Size

Total Sample Size="35"
Sample Size from India="35"
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)

28/08/2026

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="0"
Months="3"
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

This clinico-hematological study will be conducted among patients aged over 18 years with known hypertension and Stage III periodontitis.The primary objective is to evaluate and compare the effectiveness of non-surgical periodontal therapy (scaling and root planing) and surgical periodontal therapy (flap surgery) on clinical periodontal parameters, blood pressure, serum C-reactive protein (CRP), and lipid profile in hypertensive patients with Stage III periodontitis.Eligible participants will undergo baseline assessment, including plaque index, gingival index, bleeding on probing, probing pocket depth, clinical attachment level, blood pressure measurement, and blood investigations for CRP and lipid profile. All patients will initially receive scaling and root planing. After 2 weeks, clinical and biochemical parameters will be reassessed. Patients with persistent periodontal pockets will then undergo flap surgery and will be re-evaluated at 3 months.The study aims to determine whether surgical therapy provides additional systemic and periodontal benefits compared to non-surgical treatment and to analyze changes in inflammatory markers and cardiovascular risk indicators over time.