Intrabony Periodontal Defect, Periodontitis
Conditions
Keywords
Nano-Hydroxyapatite, MINST, Minimally Invasive Non-Surgical Technique, Periodontal Regeneration
Brief summary
This randomized controlled clinical trial aims to evaluate the effectiveness of using nano-hydroxyapatite (nHA) gel alongside a minimally invasive non-surgical technique (MINST) to treat deep intra-bony defects in patients with Stage III periodontitis. While MINST is an effective method for cleaning deep periodontal pockets without the need for traditional surgery, the addition of nHA may further enhance soft tissue healing, improve cellular interaction, and promote bone 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 nHA gel directly 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 nHA provides superior clinical outcomes compared to non-surgical treatment alone.
Interventions
Subgingival debridement using thin ultrasonic tips and Gracey mini-curettes under magnification, deliberately avoiding subgingival rinsing to support blood clot stabilization
BIOLOGICALnano-hydroxyapatite
A single dose of nano-hydroxyapatite (nHA) gel applied subgingivally directly into the periodontal pocket associated with the intrabony defect immediately following 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 65 Years
Healthy volunteers
No
Inclusion criteria
* Systemically healthy adults aged 18-65 years. * No history of systemic diseases affecting periodontal status or bone metabolism (e.g., uncontrolled diabetes, osteoporosis). * Diagnosed with Stage III periodontitis according to the 2018 classification of periodontal diseases (with interdental CAL ≥5 mm, probing depth ≥6 mm). * Presence of at least one deep intra-bony defect (≥3 mm defect depth) in a single-rooted or multi-rooted tooth. * Willingness to participate and sign informed consent.
Exclusion criteria
* Immunocompromised patients, uncontrolled diabetics (HbA1c ≥ 7.0%), or individuals with autoimmune disorders. * History of malignancy or chemotherapy/radiation in the past year. * Use of bisphosphonates, corticosteroids, immunosuppressive antibiotics or anti-inflammatory agents within 6 months before periodontal therapy. * Smokers (≥ 10 cigarettes per day). * Pregnant or breastfeeding women, confirmed via medical history and/or test. * Receipt of periodontal surgery or nonsurgical treatment within the last 6 months. * Teeth with peri-apical pathology, acute abscess, or grade III mobility. * Multi-rooted teeth with class II and class III furcation defects. * Third molars.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probing Pocket Depth (PPD) | 6 months | Measured in millimeters (mm) using a manual periodontal probe (UNC-15) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Full-Mouth Plaque Score (FMPS) | 1, 3, and 6 months post-treatment. | Assessed as a percentage (%) using the Visible Plaque Index (O'Leary et al.). The index ranges from a minimum of 0% to a maximum of 100%. Higher percentages indicate a greater presence of plaque, representing a worse clinical outcome. |
| Full-Mouth Bleeding Score (FMBS) | 1, 3, and 6 months post-treatment. | Assessed as a percentage (%) using the Gingival Bleeding Index (Ainamo \& Bay). The index ranges from a minimum of 0% to a maximum of 100%. Higher percentages indicate more widespread gingival bleeding, representing a worse clinical outcome. |
| Clinical Attachment Level (CAL) | 1, 3, and 6 months post-treatment. | Measured in millimeters (mm) using a manual periodontal probe (UNC-15). |
| Gingival Recession (GR) | 1, 3, and 6 months post-treatment. | Measured in millimeters (mm) using a manual periodontal probe (UNC-15). |
| Radiographic Defect Angle (RDA) | 1, 3, and 6 months post-treatment. | Measured in degrees (°) utilizing standardized periapical radiographs and measurement software. |
| Patient Satisfaction | 1, 3, and 6 months post-treatment. | Assessed via a structured questionnaire utilizing a Likert scale. The scale ranges from 1 to 5, where 1 indicates "Very Dissatisfied" and 5 indicates "Very Satisfied," meaning higher scores represent a better outcome. |
| Cost Effectiveness based on Clinical Attachment Level (CAL) | 6 months post-treatment. | Evaluated using the cost-effectiveness ratio (CER) and incremental cost-effectiveness ratio (ICER), based on the cost in USD per millimeter (mm) of CAL improvement. |
| Cost Effectiveness based on Probing Pocket Depth (PPD) | 6 months post-treatment. | Evaluated using the cost-effectiveness ratio (CER) and incremental cost-effectiveness ratio (ICER), based on the cost in USD per millimeter (mm) of PPD improvement. |
Countries
Egypt
Outcome results
None listed