Novel Photosensitizer in The Treatment of Chronic Periodontitis

NCT ID: NCT04374383

Last Updated: 2020-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2021-11-30

Brief Summary

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The aim of this study is to evaluate the periodontal outcomes after applying antimicrobial photodynamic therapy with a novel photosensitizer as compared to LASER assisted scaling and root planing alone.

Detailed Description

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LASER assisted SRP followed by antimicrobial photodynamic therapy with a novel photosensitizer dye Phthalocyanine will be done in test group subjects.

Conditions

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Periodontitis Alveolar Bone Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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main treatment group

LASER assisted SRP followed by antimicrobial photodynamic therapy with a novel photosensitizer dye Phthalocyanine

Group Type EXPERIMENTAL

Phthalocyanine Dye

Intervention Type DRUG

following LASER assisted SRP, a novel photosensitizer phthalocyanine dye will be placed

LASER assisted SRP

Intervention Type DRUG

LASER assisted SRP will be carried

control group

LASER assisted SRP

Group Type PLACEBO_COMPARATOR

LASER assisted SRP

Intervention Type DRUG

LASER assisted SRP will be carried

Interventions

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Phthalocyanine Dye

following LASER assisted SRP, a novel photosensitizer phthalocyanine dye will be placed

Intervention Type DRUG

LASER assisted SRP

LASER assisted SRP will be carried

Intervention Type DRUG

Other Intervention Names

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Experimental group Control group

Eligibility Criteria

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Inclusion Criteria

* Systemically healthy male and female patients of age 30-60 years with generalized probing pocket depths (PPD) indicative of chronic periodontitis and with atleast two sites with PPD ≥5mm in each quadrant

Exclusion Criteria

* Medically compromised patients, Subjects with a history of periodontal intervention within 6 months of the commencement of the study and smokers
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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SVS Institute of Dental Sciences

OTHER

Sponsor Role lead

Responsible Party

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Dr R Viswa Chandra

Primary Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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R V Chandra

Hyderabad, Telangana, India

Site Status RECRUITING

SVS Institute of Dental Sciences

Hyderabad, Telangana, India

Site Status RECRUITING

Countries

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India

Central Contacts

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RVchandra, MDS; DNB

Role: CONTACT

9908183071

Facility Contacts

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R V Chandra, MDS;DNB;PhD

Role: primary

9908183071

RVchandra, MDS;DNB;PhD

Role: primary

9908183071

Other Identifiers

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SVSIDS/PERIO/2/2019

Identifier Type: -

Identifier Source: org_study_id

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