Periodontal Disease, Periodontitis
Conditions
Brief summary
This randomized controlled clinical trial aims to evaluate the effectiveness of using nano-hyaluronic acid (nano-HyA) gel alongside a minimally invasive non-surgical technique (MINST) to treat deep intrabony defects in patients with Stage II and III periodontitis. While MINST is a proven method for cleaning deep periodontal pockets without the need for traditional surgery , the addition of nano-HyA may further enhance soft tissue healing, reduce inflammation, and promote regeneration. Participants in the study will be randomly assigned to one of two groups. The test group will receive the MINST procedure combined with the application of nano-HyA gel into the periodontal pocket, while the control group will receive the MINST procedure alone. The primary goal of the study is to measure the decrease in probing pocket depth over a 6-month follow-up period to determine if the adjunctive use of nano-HyA provides superior clinical and radiographic outcomes compared to non-surgical treatment alone
Interventions
Subgingival debridement using thin ultrasonic tips and additional instrumentation with Gracey mini-curettes, deliberately avoiding subgingival rinsing to support blood clot stabilization
BIOLOGICALnano-hyaluronic acid
Pockets associated with intrabony defects are filled with nano-HyA paste immediately after subgingival debridement
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males and females aged ≥ 18 years. 2. Patients with a diagnosis of periodontitis (stage II or III). 3. At least one tooth with ≥5 mm PPD and CAL and evidence of radiographic bone loss. 4. Presenting with at least 1 intrabony defect, with a radiographic intra-bony component ≥3 mm.
Exclusion criteria
1. Patients with systemic diseases. 2. Pregnant or lactating females. 3. Tobacco smokers (≥ 10 cigarettes per day). 4. Multi-rooted teeth with class II and class III furcation defects. 5. Third molars. 6. Teeth with grade III mobility. 7. Peri-apical pathology and acute abscess. 8. Non-surgical or surgical periodontal treatment in the past 12 months. 9. Prolonged treatment with antibiotics or anti-inflammatory agents within 6 months before periodontal therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pocket Depth (PD) | "From enrollment to the end of treatment at 24 weeks" | Measured in millimeters (mm) from the gingival margin to the bottom of the gingival sulcus using a UNC-15 periodontal probe. Each tooth is probed at 6 sites with a light force not exceeding 25 grams. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Full-Mouth Plaque Score (FMPS) | From enrollment to the end of treatment at 24 weeks | Assessed as the percentage of sites with plaque. |
| Full-Mouth Bleeding Score (FMBS) | From enrollment to the end of treatment at 24 weeks | Assessed as the percentage of sites with bleeding upon probing. |
| Clinical Attachment Level (CAL) | From enrollment to the end of treatment at 24 weeks | Measured in millimeters (mm) from the cemento-enamel junction to the bottom of the pocket. |
| Gingival Recession (GR) | From enrollment to the end of treatment at 24 weeks | Measured in millimeters (mm) from the cemento-enamel junction to the gingival margin. |
| Radiographic Defect Angle (RDA) | From enrollment to the end of treatment at 24 weeks | Measured in degrees (°). |
| Patient Satisfaction | From enrollment to the end of treatment at 24 weeks | Assessed via a Likert-scale questionnaire. The scale ranges from 1 to 5, where 1 indicates "Very Dissatisfied" and 5 indicates "Very Satisfied". Higher scores represent a better outcome. |
| Cost Effectiveness | From enrollment to the end of treatment at 24 weeks | Evaluated through a health economic analysis, measured as currency per unit effect. |
Countries
Egypt
Outcome results
None listed