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

KLE Society's Institute of Dental Sciences

Status: Unknown

Conditions: Chronic Periodontitis

Treatments: Procedure: Photodynamic therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03770819

KIDSperio-PDT

Details and patient eligibility

About

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.

Full 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).

Enrollment: 16 estimated patients

Sex: All

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16 participants in 4 patient groups, including a placebo group

Placebo group

Placebo Comparator group

Description:

Application of placebo gel followed by sham Photodynamic therapy

Treatment:

Procedure: Photodynamic therapy

Zinc oxide gel group

Active Comparator group

Description:

Application of Zinc oxide gel followed by sham Photodynamic therapy.

Treatment:

Procedure: Photodynamic therapy

PDT group

Experimental group

Description:

Application of placebo gel followed by Photodynamic therapy.

Treatment:

Procedure: Photodynamic therapy

Zinc oxide and PDT group

Experimental group

Description:

Application of Zinc oxide gel followed by Photodynamic therapy.

Treatment:

Procedure: Photodynamic therapy