Chronic Periodontitis
Conditions
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).
Interventions
PROCEDUREPhotodynamic 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.
Sponsors
University of Mysore
KLE Society's Institute of Dental Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
This is a Split Mouth Double Blind Randomized Controlled Clinical Trial in which both participants and care provider are blinded.
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
Eligibility
Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Microbial profile | 3 months | Change in levels of P.gingivalis following PDT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Plaque index score | 3 months | Change in plaque index score from Range: 2-3 to Range: 0 to1.9 following PDT |
| Change in Gingival index score | 3 months | Change in Gingival index score from Range: 2-3 to Range: 0 to1.9 following PDT |
| Probing pocket depth | 3 months | Change in probing pocket depth from 5-7 mm to 2.9- 4.2 mm following PDT |
| Clinical attachment level | 3 months | Gain in clinical attachment level following PDT |
Outcome results
None listed