Periodontitis Stage III
Conditions
Keywords
Periodontitis, Resveratrol, Nanoparticles, Cox-2, Scaling, root planing, Gingival crevicular fluid, Superoxide dismutase
Brief summary
The Aim of this study is to test the effectiveness of locally applied resveratrol as an adjunct to scaling and root planing in the treatment of periodontitis (primary outcome) . Also to assess the level of COX-2 and superoxide dismutase (SOD) in the gingival crevicular fluid samples using the commercially available kits.
Detailed description
Patients who are accepted for this study will be screened by a comprehensive periodontal examination and full periodontal charts. Proper Diagnosis of the stages of periodontitis will be based on the new classification proposed in 2017 AAP World Workshop. * Clinical periodontal parameters, including: 1. Plaque Index (PI), according to Silness P. Loe H 1964. 2. Gingival Index (GI), according to Silness P. Loe H 1963. 3. Eastman Interdental Bleeding Index (EIBI), according to Ainamo & Bay 1975 . 4. Clinical Attachment Level (CAL) is measured from cemento enemal junction to base of the pocket. 5. Probing Pocket Depth(PPD) is measured from free gingival margin to base of the pocket. ALL these parameters will be assessed at baseline and after 3 months after treatment for groups 2, 3 and 4 while at baseline only for group 1. * GCF samples will be collected using sterile paper strips and analyzed using the commercially available kits for the assessment of the level of COX-2 and SOD at baseline and after 3 months after treatment for groups 2, 3 and 4 while at baseline only for group 1. After proper and accurate examination and diagnosis, full mouth supra- and subgingival SRP will be performed with ultrasonic tips and Gracey curettes (Hu-Friedy, Chicago, United States) and an ultrasonic device (Minipiezon, EMS \[Electro Medical System\], Le Sentier, Switzerland). All patients will receive oral hygiene instructions. After completion of SRP, RES loaded gel will be injected in the selected periodontal pocket of the test group (group 4) while RES unloaded gel will be injected as placebo gel in group 3 using a syringe with a blunt cannula until the pocket will be completely filled. After atraumatic application of the local drug delivery system, the Patients will be instructed to avoid chewing hard, eating any sticky foods for several hours.
Interventions
DRUGResveratrol loaded gel
Locally injection of Resveratrol Loaded Nanoparticles in patients with stage II periodontitis according to 2017 classification in group 4 only while group 3 will be injected with placebo also group 2 will be treated with only SRP but group 1 is the healthy group ,these participants will only be screened by a comprehensive periodontal examination and full periodontal charts. Proper Diagnosis of the stages of periodontitis will be based on the new classification proposed in 2017 AAP World Workshop and no intervention will be done .
Sponsors
Hagar Ahmed Ali Mohammed Elzain
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Adult patient 25-55 years. 2. Presence of ≥20 teeth. 3. PPD \>3\&≤5 mm. 4. The patients are in good systemic health. 5. Patients have not received any periodontal surgery in the areas that will be assessed in the last 6 months
Exclusion criteria
1. Patients with systemic diseases. 2. Pregnant and lactating women. 3. Heavy Smokers and tobacco chewers. 4. Patients do not follow oral hygiene measures. 5. Patients with a known or suspected allergy to any material used in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical attachment level (CAL) as Clinical periodontal parameter | 3 months | Patients who are accepted for this study will be screened by periodontal examination and full periodontal charts. Proper Diagnosis of the stages of periodontitis will be based on the new classification proposed in 2017. Clinical attachment level (CAL) as Clinical periodontal parameter in mm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| laboratory evaluation of Cox-2 & SOD in GCF | 3 months | GCF samples will be collected using sterile paper strips and analyzed using the commercially available kits for the assessment of the level of COX-2 and SOD at baseline and after 3 months after treatment for groups 2, 3 and 4 while at baseline only for group 1. |
Countries
Egypt
Outcome results
None listed