Periodontal Bone Loss, Periodontal Diseases
Conditions
Keywords
drug delivery, Centella Asiatica Nanoemulsion
Brief summary
The aims of the current study are: 1. Evaluation of the clinical efficacy of local delivery of nanoemulsion gel containing Centella asiatica extract as an adjunct to conventional non-surgical periodontal therapy in periodontitis patients. 2. Evaluation of the antioxidant effect of this treatment by the assessment of nuclear factor erythroid 2-related factor 2 (NrF2) and glutathione peroxidase 1 (GPX1) in the gingival crevicular fluid (GCF) samples.
Detailed description
Forty-five healthy patients with periodontitis and healthy subjects with healthy periodontium will be included in the current study. At the beginning of the treatment, all selected patients will be motivated about the benefit of plaque control and periodontal prophylaxis. The participants will be selected from the Outpatient Clinic of the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Mansoura University. The patients will be informed about the treatment that they will receive and steps that will be taken. This includes the possible effects or risks and other treatment options according to the rules of the ethical committee of the Faculty of Dentistry, Mansoura University. The subjects must understand this explanation in broad terms. They must be legally competent to give written consent before performing any required steps. The research protocol will be presented to the ethical committee at the Faculty of Dentistry, Mansoura University, to get its approval.
Interventions
DRUGCentella asiatica nanoemulsion gel
Following scaling and root planing, patients in Group 1 received local subgingival application of Centella asiatica nanoemulsion gel via disposable syringe with a blunt-ended cannula, applied once weekly for 3 months.
PROCEDUREScaling and Root Planing (SRP)
Full-mouth scaling and root planing using ultrasonic instrumentation and Gracey curettes, plus standardized oral hygiene instructions.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 25-55 years, either sex * Diagnosis of periodontal health OR Stage III periodontitis (per 2017 World Workshop Classification)
Exclusion criteria
* Known allergy or sensitivity to any component of the study medication * Systemic antibiotics or anti-inflammatory medications within the preceding 6 months * Uncontrolled diabetes mellitus * Cardiovascular disease * Rheumatoid arthritis * Renal disease * Pulmonary disease * Thyroid disease * Malignancy * Current smokers * Pregnant or lactating women * Unable or unwilling to comply with prescribed oral hygiene instructions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plaque Index | Baseline and 3 months (Groups 1 and 2); baseline only (Group 3) | Full-mouth plaque accumulation scored at the mesial, distal, buccal, and lingual/palatal surfaces of each examined tooth on a 0-3 scale, with higher scores indicating greater plaque accumulation. The participant-level score is the average of all recorded surface scores. |
| Gingival Index | Baseline and 3 months (Groups 1 and 2); baseline only (Group 3) | Gingival inflammation was scored at each examined surface on a 0-3 scale based on gingival color, consistency, and presence/absence of bleeding on probing, with higher scores indicating more severe inflammation (0 = clinically healthy gingiva, 3 = severe inflammation with marked redness, edema, ulceration, or spontaneous bleeding). |
| Gingival Bleeding Index | Baseline and 3 months (Groups 1 and 2); baseline only (Group 3) | Presence or absence of bleeding recorded following gentle probing of the gingival margin at each examined site, calculated as the number of bleeding sites divided by the total number of examined sites and expressed as a percentage. Higher percentages indicate greater gingival bleeding. |
| Periodontal Probing Depth (PPD) | Baseline and 3 months (Groups 1 and 2); baseline only (Group 3) | Distance in millimeters from the free gingival margin to the base of the periodontal pocket, measured at multiple sites per tooth using a calibrated periodontal probe. Higher values indicate deeper pockets and greater periodontal destruction. |
| Clinical Attachment Level (CAL) | Baseline and 3 months (Groups 1 and 2); baseline only (Group 3) | Distance in millimeters from the cemento-enamel junction to the base of the periodontal pocket, measured at multiple sites per tooth using a calibrated periodontal probe. Higher values indicate greater loss of periodontal attachment |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORMajed M Alshammari, bachelor
faculty of dentistry Mansoura university
Outcome results
None listed