PDT As An Adjunct To SRP In The Management of Chronic Periodontitis
Primary Purpose
Chronic Periodontitis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Photodynamic therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis
Eligibility Criteria
Inclusion Criteria:
- Patients of both genders diagnosed with chronic periodontitis in the age group of 30 to 50 years with good systemic health.
- Presence of a minimum of 20 teeth and at least one site with probing pocket depth (PPD) of 4-7 mm and clinical attachment level (CAL) of 2 mm or greater, in each of the four quadrants.
Exclusion Criteria:
- Patients who have undergone periodontal therapy during the previous 6 months of commencement of the study.
- Subjects on antibiotics or immunosuppressant medication 6 months prior to the study.
- Chronic Smokers, Alcoholics, Smokeless tobacco users.
- Subjects with acute illnesses/acute intraoral lesions.
- Pregnant women and lactating mothers.
- Medically compromised subjects.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Experimental
Experimental
Arm Label
Placebo group
Zinc oxide gel group
PDT group
Zinc oxide and PDT group
Arm Description
Application of placebo gel followed by sham Photodynamic therapy
Application of Zinc oxide gel followed by sham Photodynamic therapy.
Application of placebo gel followed by Photodynamic therapy.
Application of Zinc oxide gel followed by Photodynamic therapy.
Outcomes
Primary Outcome Measures
Change in Microbial profile
Change in levels of P.gingivalis following PDT
Secondary Outcome Measures
Change in Plaque index score
Change in plaque index score from Range: 2-3 to Range: 0 to1.9 following PDT
Change in Gingival index score
Change in Gingival index score from Range: 2-3 to Range: 0 to1.9 following PDT
Probing pocket depth
Change in probing pocket depth from 5-7 mm to 2.9- 4.2 mm following PDT
Clinical attachment level
Gain in clinical attachment level following PDT
Full Information
NCT ID
NCT03770819
First Posted
December 6, 2018
Last Updated
February 25, 2019
Sponsor
KLE Society's Institute of Dental Sciences
Collaborators
University of Mysore
1. Study Identification
Unique Protocol Identification Number
NCT03770819
Brief Title
PDT As An Adjunct To SRP In The Management of Chronic Periodontitis
Official Title
Photodynamic Therapy Using Zinc Oxide Photosensitizer As An Adjunct To Scaling And Root Planing In The Management Of Chronic Periodontitis - A Split Mouth Double Blind Randomized Controlled Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 2019 (Anticipated)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KLE Society's Institute of Dental Sciences
Collaborators
University of Mysore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The present study aims to evaluate photodynamic therapy (PDT) using Zinc oxide as a photosensitizer as an adjunct to scaling and root planing (SRP) in the management of chronic periodontitis.
Detailed Description
Following full mouth SRP, each quadrant will be randomly assigned by simple randomization using a computer generated randomization technique into one of the following four treatment modalities.
Group 1 (control) - Application of placebo gel followed by sham PDT (Directing the Light cure device without turning on the light beam).
Group 2 -Application of Zinc oxide gel followed by sham PDT. Group 3 - Application of placebo gel followed by PDT. Group 4 - Application of Zinc oxide gel followed by PDT. The procedure mentioned for each group will be performed on all periodontal pockets in the assigned quadrant at baseline, end of 1 week and 1 month from the first session.
Clinical parameters and microbial profile will be recorded at baseline (before commencement of Periodontal treatment), end of 1 month and end of 3 months following periodontal treatment.
Zinc oxide gel/placebo gel will be placed into the periodontal pockets using a blunt cannula ensuring that starting from the bottom, it completely fills the periodontal pockets. The gel will be retained in the pocket for 5 minutes. The perio tip will be attached to the hand piece of the light cure unit (Wavelength: 420-480nm. Light power: 1200mw/cm2 in continuous mode) and light will be activated for 60 seconds. Following this, the pockets will be irrigated with normal saline solution (0.9%Sodium chloride).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
16 patients contributing a total of 64 sites will be selected. Recording of clinical and microbiological parameters will be done at baseline, end of 1 month, and 3 months. Oral hygiene instructions will be given. Following full mouth SRP, each quadrant will be randomly assigned by simple randomization using a computer generated randomization technique into one of the following four treatment modalities.
Group 1 (control) - Application of placebo gel followed by sham PDT (Directing the Light cure device without turning on the light beam).
Group 2 -Application of Zinc oxide gel followed by sham PDT. Group 3 - Application of placebo gel followed by PDT. Group 4 - Application of Zinc oxide gel followed by PDT. The procedure mentioned for each group will be performed on all periodontal pockets in the assigned quadrant at baseline, end of 1 week and 1 month from the first session.
Study period - 3 months
Masking
ParticipantCare Provider
Masking Description
This is a Split Mouth Double Blind Randomized Controlled Clinical Trial in which both participants and care provider are blinded.
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Application of placebo gel followed by sham Photodynamic therapy
Arm Title
Zinc oxide gel group
Arm Type
Active Comparator
Arm Description
Application of Zinc oxide gel followed by sham Photodynamic therapy.
Arm Title
PDT group
Arm Type
Experimental
Arm Description
Application of placebo gel followed by Photodynamic therapy.
Arm Title
Zinc oxide and PDT group
Arm Type
Experimental
Arm Description
Application of Zinc oxide gel followed by Photodynamic therapy.
Intervention Type
Procedure
Intervention Name(s)
Photodynamic therapy
Intervention Description
Zinc oxide gel/placebo gel will be placed into the periodontal pockets using a blunt cannula ensuring that starting from the bottom, it completely fills the periodontal pockets. The gel will be retained in the pocket for 5 minutes. The perio tip will be attached to the hand piece of the light cure unit (Wavelength: 420-480nm. Light power: 1200mw/cm2 in continuous mode) and light will be activated for 60 seconds. Following this, the pockets will be irrigated with normal saline solution (0.9%Sodium chloride).
For groups 1 and 2, sham PDT will be performed by directing the Light cure device without turning on the light beam.
Primary Outcome Measure Information:
Title
Change in Microbial profile
Description
Change in levels of P.gingivalis following PDT
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in Plaque index score
Description
Change in plaque index score from Range: 2-3 to Range: 0 to1.9 following PDT
Time Frame
3 months
Title
Change in Gingival index score
Description
Change in Gingival index score from Range: 2-3 to Range: 0 to1.9 following PDT
Time Frame
3 months
Title
Probing pocket depth
Description
Change in probing pocket depth from 5-7 mm to 2.9- 4.2 mm following PDT
Time Frame
3 months
Title
Clinical attachment level
Description
Gain in clinical attachment level following PDT
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients of both genders diagnosed with chronic periodontitis in the age group of 30 to 50 years with good systemic health.
Presence of a minimum of 20 teeth and at least one site with probing pocket depth (PPD) of 4-7 mm and clinical attachment level (CAL) of 2 mm or greater, in each of the four quadrants.
Exclusion Criteria:
Patients who have undergone periodontal therapy during the previous 6 months of commencement of the study.
Subjects on antibiotics or immunosuppressant medication 6 months prior to the study.
Chronic Smokers, Alcoholics, Smokeless tobacco users.
Subjects with acute illnesses/acute intraoral lesions.
Pregnant women and lactating mothers.
Medically compromised subjects.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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PDT As An Adjunct To SRP In The Management of Chronic Periodontitis
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