PDT As An Adjunct To SRP In The Management of Chronic Periodontitis

Chronic Periodontitis Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03770819
• Other study ID #: KIDSperio-PDT
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2019
• Est. completion date: June 2019

Study information

• Verified date: February 2019
• Source: KLE Society's Institute of Dental Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: June 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Procedure:
• Photodynamic therapy
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
KLE Society's Institute of Dental Sciences	University of Mysore

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Microbial profile	Change in levels of P.gingivalis following PDT	3 months
Secondary	Change in Plaque index score	Change in plaque index score from Range: 2-3 to Range: 0 to1.9 following PDT	3 months
Secondary	Change in Gingival index score	Change in Gingival index score from Range: 2-3 to Range: 0 to1.9 following PDT	3 months
Secondary	Probing pocket depth	Change in probing pocket depth from 5-7 mm to 2.9- 4.2 mm following PDT	3 months
Secondary	Clinical attachment level	Gain in clinical attachment level following PDT	3 months