Periodontitis, Alveolar Bone Loss
Conditions
Brief summary
The aim of this study is to evaluate the periodontal outcomes after applying antimicrobial photodynamic therapy with a novel photosensitizer as compared to LASER assisted scaling and root planing alone.
Detailed description
LASER assisted SRP followed by antimicrobial photodynamic therapy with a novel photosensitizer dye Phthalocyanine will be done in test group subjects.
Interventions
DRUGPhthalocyanine Dye
following LASER assisted SRP, a novel photosensitizer phthalocyanine dye will be placed
LASER assisted SRP will be carried
Sponsors
SVS Institute of Dental Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Systemically healthy male and female patients of age 30-60 years with generalized probing pocket depths (PPD) indicative of chronic periodontitis and with atleast two sites with PPD ≥5mm in each quadrant
Exclusion criteria
* Medically compromised patients, Subjects with a history of periodontal intervention within 6 months of the commencement of the study and smokers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Release profile of the drug | Change from baseline to 7-days. | Release profile of the drug in Gingival Crevicular Fluid (GCF) samples will be evaluated through biochemical testing kits. |
| probing pocket depths (PPD) | Change from baseline to 6-months. | Assessment of probing pocket depths (PPD, in mm) by using a manual periodontal probe on six sites (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual and distolingual) will be performed. |
| clinical attachment level (CAL) | Change from baseline to 6-months. | Assessment of clinical attachment level (CAL, in mm) by using a manual periodontal probe on six sites (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual and distolingual) will be performed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| plaque index (PI) | Change from baseline to 6-months. | Assessment of plaque (PI) - according to Turesky modification of Quigley and Hein Plaque Index; 0-No plaque 1-Isolated flecks of plaque at the gingival margin 2-A continuous band of plaque up to 1mm at the gingival margin 3-Plaque greater than 1mm in width and covering up to one third of the tooth surface 4-Plaque covering from one thirds to two thirds of the tooth surface 5-Plaque covering more than two thirds of the tooth surface. |
| bleeding on probing (BOP) | Change from baseline to 6-months. | Assessment of bleeding on probing (BOP) as a dichotomous variable (Yes/No) by using a manual periodontal probe. |
Countries
India
Contacts
Primary ContactRVchandra, MDS; DNB
Outcome results
None listed