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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-31

Study Completion Date

2019-06-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Chronic Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

This is a Split Mouth Double Blind Randomized Controlled Clinical Trial in which both participants and care provider are blinded.

Study Groups

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Placebo group

Application of placebo gel followed by sham Photodynamic therapy

Group Type PLACEBO_COMPARATOR

Photodynamic therapy

Intervention Type PROCEDURE

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.

Zinc oxide gel group

Application of Zinc oxide gel followed by sham Photodynamic therapy.

Group Type ACTIVE_COMPARATOR

Photodynamic therapy

Intervention Type PROCEDURE

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.

PDT group

Application of placebo gel followed by Photodynamic therapy.

Group Type EXPERIMENTAL

Photodynamic therapy

Intervention Type PROCEDURE

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.

Zinc oxide and PDT group

Application of Zinc oxide gel followed by Photodynamic therapy.

Group Type EXPERIMENTAL

Photodynamic therapy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes