Novel Photosensitizer in The Treatment of Chronic Periodontitis
Primary Purpose
Periodontitis, Alveolar Bone Loss
Status
Unknown status
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Phthalocyanine Dye
LASER assisted SRP
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis
Eligibility Criteria
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
Sites / Locations
- R V ChandraRecruiting
- SVS Institute of Dental SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
main treatment group
control group
Arm Description
LASER assisted SRP followed by antimicrobial photodynamic therapy with a novel photosensitizer dye Phthalocyanine
LASER assisted SRP
Outcomes
Primary Outcome Measures
Release profile of the drug
Release profile of the drug in Gingival Crevicular Fluid (GCF) samples will be evaluated through biochemical testing kits.
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.
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.
Secondary Outcome Measures
plaque index (PI)
Assessment of plaque (PI) - according to Turesky modification of Quigley and Hein Plaque Index; 0-No plaque 1-Isolated flecks of plaque at the gingival margin 2-A continuous band of plaque up to 1mm at the gingival margin 3-Plaque greater than 1mm in width and covering up to one third of the tooth surface 4-Plaque covering from one thirds to two thirds of the tooth surface 5-Plaque covering more than two thirds of the tooth surface.
bleeding on probing (BOP)
Assessment of bleeding on probing (BOP) as a dichotomous variable ("Yes"/"No") by using a manual periodontal probe.
Full Information
NCT ID
NCT04374383
First Posted
April 29, 2020
Last Updated
May 5, 2020
Sponsor
SVS Institute of Dental Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04374383
Brief Title
Novel Photosensitizer in The Treatment of Chronic Periodontitis
Official Title
Clinical Effects of a Single Application of a Novel Photosensitizer in The Treatment of Chronic Periodontitis - A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
November 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
SVS Institute of Dental Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
LASER assisted SRP followed by antimicrobial photodynamic therapy with a novel photosensitizer dye Phthalocyanine will be done in test group subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Alveolar Bone Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
main treatment group
Arm Type
Experimental
Arm Description
LASER assisted SRP followed by antimicrobial photodynamic therapy with a novel photosensitizer dye Phthalocyanine
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
LASER assisted SRP
Intervention Type
Drug
Intervention Name(s)
Phthalocyanine Dye
Other Intervention Name(s)
Experimental group
Intervention Description
following LASER assisted SRP, a novel photosensitizer phthalocyanine dye will be placed
Intervention Type
Drug
Intervention Name(s)
LASER assisted SRP
Other Intervention Name(s)
Control group
Intervention Description
LASER assisted SRP will be carried
Primary Outcome Measure Information:
Title
Release profile of the drug
Description
Release profile of the drug in Gingival Crevicular Fluid (GCF) samples will be evaluated through biochemical testing kits.
Time Frame
Change from baseline to 7-days.
Title
probing pocket depths (PPD)
Description
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.
Time Frame
Change from baseline to 6-months.
Title
clinical attachment level (CAL)
Description
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.
Time Frame
Change from baseline to 6-months.
Secondary Outcome Measure Information:
Title
plaque index (PI)
Description
Assessment of plaque (PI) - according to Turesky modification of Quigley and Hein Plaque Index; 0-No plaque 1-Isolated flecks of plaque at the gingival margin 2-A continuous band of plaque up to 1mm at the gingival margin 3-Plaque greater than 1mm in width and covering up to one third of the tooth surface 4-Plaque covering from one thirds to two thirds of the tooth surface 5-Plaque covering more than two thirds of the tooth surface.
Time Frame
Change from baseline to 6-months.
Title
bleeding on probing (BOP)
Description
Assessment of bleeding on probing (BOP) as a dichotomous variable ("Yes"/"No") by using a manual periodontal probe.
Time Frame
Change from baseline to 6-months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
RVchandra, MDS; DNB
Phone
9908183071
Email
viswachandra@hotmail.com
Facility Information:
Facility Name
R V Chandra
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
509002
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R V Chandra, MDS;DNB;PhD
Phone
9908183071
Email
viswachandra@hotmail.com
Facility Name
SVS Institute of Dental Sciences
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
509002
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RVchandra, MDS;DNB;PhD
Phone
9908183071
Email
viswachandra@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Novel Photosensitizer in The Treatment of Chronic Periodontitis
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