CTRI

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CTRI Number

CTRI/2018/05/013918 [Registered on: 16/05/2018] Trial Registered Prospectively

Last Modified On:

16/05/2018

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group, Placebo Controlled Trial

Public Title of Study

comparative evaluation of non surgical periodontal therapy in chronic periodontitis with and without administration of curcumin pastilles.

Scientific Title of Study

â€œTo compare the effect of non surgical periodontal therapy in chronic periodontitis with and without administration of curcumin pastilles-A clinico-microbiological studyâ€™â€™.

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Dr Varsha Ranmare
Designation	PG student
Affiliation	MGVs KBH Dental college,Nashik
Address	dept.of periodontology and implantology,M.g.v kbh dental college,nashik Nashik MAHARASHTRA 422003 India
Phone	9403756504
Fax	9403756504
Email	ranmarevarsha@gmail.com

Details of Contact Person
Scientific Query

Name	Drtriveni kale
Designation	professor,pg guide
Affiliation	MGVs KBH Dental college,Nashik
Address	m.g.v k.b.h dental college,nashik Nashik MAHARASHTRA 422003 India
Phone	9403756504
Fax
Email	trivenikale@gmail.com

Details of Contact Person
Public Query

Name	Dr Varsha Ranmare
Designation	PG student
Affiliation	MGVs KBH Dental college,Nashik
Address	dept.of periodontology,MGVs KBH dental college,nashik Nashik MAHARASHTRA 422003 India
Phone	9403756504
Fax	9403756504
Email	ranmarevarsha@gmail.com

Source of Monetary or Material Support

gelnova laboratories

Primary Sponsor

Name	Dr Varsha Ranmare
Address	sawali plot no.37,survey no.93,tantradnya nagar,satara parisar,aurangabad
Type of Sponsor	Pharmaceutical industry-Indian

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
DrVarsha Ranmare	MGVs KBH dental college and hospital Nashik	dept of periodontology and implantology Nashik MAHARASHTRA	9403756504 9403756504 ranmarevarsha@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Synopsis approval committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	chronic periodontitis,

Intervention / Comparator Agent

Type	Name	Details
Intervention	curcumin pastilles	curcumin patilles which contains turmeric given twice through oral route a day for 3 months
Comparator Agent	not applicable	not applicable

Inclusion Criteria

Age From	20.00 Year(s)
Age To	50.00 Year(s)
Gender	Both
Details	1)Chronic periodontitis with probing pocket depth â‰¥6mm 2)Presence of atleast 20 teeth

ExclusionCriteria

Details

1)Patients with systemic diseases
2)History of periodontal therapy in the past 6 months
3)Patients on antibiotic use within the past 6 months prior to study
4)Allergy to any test materials
5)Pregnant or lactating females
6)Aggressive periodontitis
7)GradeII and gradeIII mobility

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
reduction(4mm)in pocket depth	parameters checked at baseline after 1 month and after 3 months

Secondary Outcome

Outcome	TimePoints
reduction in microbial count after 3 months	parameters assessed at baseline and after 1 and 3 month

Target Sample Size

Total Sample Size="30"
Sample Size from India="30"
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)

21/05/2018

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="8"
Days="30"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

not yet published

Individual Participant Data (IPD) Sharing Statement

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

Brief Summary

abstract:-

background:-periodontitis is a infectious disease so the main aim of periodontal therapy is scaling and root planing which is solely not effective so the adjunctive therapy is given such as Medicinal plants have been used as a traditional treatment agent for various human diseases since years.as it is feasible,lesser side effects and ease of availability.so the aim of the study is to compare the the effect of non surgical periodontal therapy in chronic periodontitis with and without administration of curcumin pastilles-A clinico-microbiological study

material and methods :-Thirty chronic periodontitis patients with an age range of 20â€“50 years with probing pocket depth (PPD) of 4â€“6 mm were included.A)Test group (15 patients):-Full mouth scaling and root planing was done with ultrasonic instrument with administration of curcumin pastilles. B)Control group(15 patients):-Full mouth scaling and root planning with ultrasonic instrument was done.clinical parameters probing pocket depth,clinical attachment level,plaque index,gingival index,gingival recession were recorded at baseline,after 1 minth and after 3 months and CFU was done.

results;-there were significant reduction in clinical parameters and microbiologic parameters at baseline,after 1 month and after 3 months in test group as compared to control group.

conclusion:-curcumin patilles being an ayurvedic herb is an excellent alternative to other systemic therapeutic agents due to minimal sideï¿½ï¿½’effects.