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

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ClinicalTrials.gov Identifier: NCT03770819
Recruitment Status : Not yet recruiting
First Posted : December 10, 2018
Last Update Posted : February 26, 2019
Sponsor:
Collaborator:
University of Mysore
Information provided by (Responsible Party):
Veena H.R, KLE Society's Institute of Dental Sciences

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.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Procedure: Photodynamic therapy Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Participant, Care Provider)
Masking Description: This is a Split Mouth Double Blind Randomized Controlled Clinical Trial in which both participants and care provider are blinded.
Primary Purpose: Treatment
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.
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo group
Application of placebo gel followed by sham Photodynamic therapy
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.


Active Comparator: Zinc oxide gel group
Application of Zinc oxide gel followed by sham Photodynamic therapy.
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.


Experimental: PDT group
Application of placebo gel followed by Photodynamic therapy.
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.


Experimental: Zinc oxide and PDT group
Application of Zinc oxide gel followed by Photodynamic therapy.
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.





Primary Outcome Measures :
  1. Change in Microbial profile [ Time Frame: 3 months ]
    Change in levels of P.gingivalis following PDT


Secondary Outcome Measures :
  1. Change in Plaque index score [ Time Frame: 3 months ]
    Change in plaque index score from Range: 2-3 to Range: 0 to1.9 following PDT

  2. Change in Gingival index score [ Time Frame: 3 months ]
    Change in Gingival index score from Range: 2-3 to Range: 0 to1.9 following PDT

  3. Probing pocket depth [ Time Frame: 3 months ]
    Change in probing pocket depth from 5-7 mm to 2.9- 4.2 mm following PDT

  4. Clinical attachment level [ Time Frame: 3 months ]
    Gain in clinical attachment level following PDT



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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Responsible Party: Veena H.R, Reader, Department of Periodontics, KLE Society's Institute of Dental Sciences
ClinicalTrials.gov Identifier: NCT03770819     History of Changes
Other Study ID Numbers: KIDSperio-PDT
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Chronic Periodontitis
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Zinc
Zinc Oxide
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Dermatologic Agents
Sunscreening Agents
Radiation-Protective Agents
Protective Agents