Stage II Grade B Periodontitis
Conditions
Brief summary
This randomized clinical trial aims to evaluate and compare the clinical and biochemical effects of an antioxidant agent and chlorhexidine when used as adjuncts to non-surgical periodontal therapy in patients with Stage II Grade B periodontitis. Eligible participants will receive scaling and root planing (SRP) and will be randomly assigned to either the antioxidant or chlorhexidine treatment group. Clinical periodontal parameters, including plaque index, gingival index, probing depth, and clinical attachment level, will be assessed at baseline and follow-up visits. Biochemical analysis of inflammatory markers, including tumor necrosis factor-alpha (TNF-α) and interleukin-1 (IL-1), will be performed to evaluate the inflammatory response to treatment. The study aims to determine whether antioxidant therapy provides comparable or superior benefits to chlorhexidine as an adjunct to non-surgical periodontal treatment.
Interventions
DRUGPerioscience Gel
Local application of Perioscience antioxidant gel into periodontal pockets following scaling and root planing (SRP).
DRUGHigh Cure Chlorhexidine Gel
Local application of High Cure chlorhexidine gel into periodontal pockets following scaling and root planing (SRP).
DRUGHigh Cure Chlorhexidine Gel + Perioscience Gel
Local application of both High Cure chlorhexidine gel and Perioscience gel into periodontal pockets following scaling and root planing (SRP).
PROCEDUREScaling and Root Planing (SRP)
Conventional full-mouth scaling and root planing performed using ultrasonic and hand instruments.
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Months to 40 Months
Healthy volunteers
No
Inclusion criteria
* 1- Patients diagnosed as having stage II periodontitis (22) 2- Clinical attachment loss ranged from 3-4mm 3- Radiographic bone loss ranged from 15% to 30%, mostly horizontal 4- Male or female aged from 25 - 40 years old
Exclusion criteria
\- 1- Smoking patient 2- Pregnancy and breastfeeding patients. 3- Patients with systemic conditions which could affect the outcome of periodontal therapy. 4- Previous periodontal therapy in last 6 month.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gingival Crevicular Fluid (GCF) Level of Interleukin-1 (IL-1) | Baseline to 6 months after treatment | Changes in the concentration of Interleukin-1 (IL-1) in gingival crevicular fluid (GCF) will be assessed before and after the intervention using an enzyme-linked immunosorbent assay (ELISA) with unit of measurement pg/mL . |
| Gingival Crevicular Fluid (GCF) Level of Tumor Necrosis Factor-alpha (TNF-α) | Baseline and 6 months after treatment | Changes in the concentration of Tumor Necrosis Factor-alpha (TNF-α) in gingival crevicular fluid (GCF) will be assessed before and after the intervention using an enzyme-linked immunosorbent assay (ELISA) with unit of measurement pg/mL . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Probing Depth (PD) | Baseline to 6 months after treatment. | Probing depth will be measured in millimeters using a periodontal probe at the selected periodontal sites. |
| Gingival Index (GI) | baseline to 6 months after treatment | Gingival status will be assessed using the Gingival Index, scored (0 - 3) at the selected periodontal sites. |
| Clinical Attachment Level (CAL) | baseline to 6 month after treatment | Clinical attachment level will be measured in millimeters using a periodontal probe at the selected periodontal sites. |
| Plaque Index (PI) | baseline to 6 month after treatment | Dental plaque accumulation will be assessed using the Plaque Index, scored (0 - 3) at the selected periodontal sites. |
Countries
Egypt
Outcome results
None listed