Novel Photosensitizer in The Treatment of Chronic Periodontitis
Clinical Effects of a Single Application of a Novel Photosensitizer in The Treatment of Chronic Periodontitis - A Randomized Controlled Trial
1 other identifier
interventional
26
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2019
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2019
CompletedFirst Submitted
Initial submission to the registry
April 29, 2020
CompletedFirst Posted
Study publicly available on registry
May 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2021
CompletedMay 7, 2020
May 1, 2020
1.4 years
April 29, 2020
May 5, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Release profile of the drug
Release profile of the drug in Gingival Crevicular Fluid (GCF) samples will be evaluated through biochemical testing kits.
Change from baseline to 7-days.
probing pocket depths (PPD)
Assessment of probing pocket depths (PPD, in mm) by using a manual periodontal probe on six sites (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual and distolingual) will be performed.
Change from baseline to 6-months.
clinical attachment level (CAL)
Assessment of clinical attachment level (CAL, in mm) by using a manual periodontal probe on six sites (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual and distolingual) will be performed.
Change from baseline to 6-months.
Secondary Outcomes (2)
plaque index (PI)
Change from baseline to 6-months.
bleeding on probing (BOP)
Change from baseline to 6-months.
Study Arms (2)
main treatment group
EXPERIMENTALLASER assisted SRP followed by antimicrobial photodynamic therapy with a novel photosensitizer dye Phthalocyanine
control group
PLACEBO COMPARATORLASER assisted SRP
Interventions
following LASER assisted SRP, a novel photosensitizer phthalocyanine dye will be placed
LASER assisted SRP will be carried
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Medically compromised patients, Subjects with a history of periodontal intervention within 6 months of the commencement of the study and smokers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
R V Chandra
Hyderabad, Telangana, 509002, India
SVS Institute of Dental Sciences
Hyderabad, Telangana, 509002, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Primary Investigator
Study Record Dates
First Submitted
April 29, 2020
First Posted
May 5, 2020
Study Start
June 1, 2019
Primary Completion
November 1, 2020
Study Completion
November 1, 2021
Last Updated
May 7, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share