Periodontal Intrabony Defects, Stage III Grade B Periodontitis
Conditions
Keywords
Stage III Periodontitis, Pinhole Regenerative Therapy (PRT), Periodontal Regeneration, Periodontal Therapy
Brief summary
Pinhole Regenerative Therapy (PRT) following minimally invasive non-surgical periodontal therapy (MINST) in the treatment of intrabony defects associated with Stage III Grade B periodontitis. Eligible patients with 2- or 3-wall intrabony defects will be randomly allocated to the study groups. Clinical outcomes, including probing pocket depth (PPD) reduction and clinical attachment level (CAL) gain, together with radiographic bone defect fill assessed by periapical radiographs and CBCT, will be evaluated over a 6-month follow-up period to determine the effectiveness of the proposed minimally invasive regenerative approacا
Detailed description
Periodontal intrabony defects associated with Stage III periodontitis remain a major clinical challenge because conventional surgical approaches may require extensive flap reflection, which can compromise soft tissue support and increase patient morbidity. Minimally invasive periodontal therapy has been introduced to preserve soft tissues while maintaining favorable clinical outcomes. This randomized controlled clinical trial is designed to evaluate the efficacy of a novel Pinhole Regenerative Therapy (PRT) in the treatment of intrabony periodontal defects. The proposed technique is based on minimally invasive non-surgical periodontal therapy (MINST) followed by a minimally invasive pinhole approach for defect degranulation and regenerative graft placement without flap elevation. The technique is intended to maximize preservation of the surrounding soft tissues while promoting periodontal regeneration. Patients diagnosed with Stage III Grade B periodontitis presenting with 2- or 3-wall intrabony defects will be recruited from the outpatient clinics of the Department of Oral Medicine and Periodontology, Faculty of Dental Medicine, Al-Azhar University. Eligible participants will be randomly allocated to the study groups according to the study protocol. The primary outcome is radiographic intrabony defect fill assessed using periapical radiographs and cone beam computed tomography (CBCT). Secondary outcomes include probing pocket depth (PPD) reduction and clinical attachment level (CAL) gain. Clinical parameters will be recorded at baseline, 3 months, and 6 months, while radiographic evaluation will be performed at baseline and 6 months.
Interventions
PROCEDURESub-junctional Pinhole Technique (S-PHT)
Four weeks after minimally invasive non-surgical therapy (MINST), intrabony defects were accessed through a small facial pinhole. Defect degranulation was performed using minimally invasive ultrasonic and hand instruments, followed by placement of hydrated xenogenic bone graft (Geistlich Bio-Oss) through the same pinhole without flap elevation
Sponsors
Al-Azhar University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
No masking was used in this case series. All participants received the same intervention, and no blinding of participants or investigators was performed
Intervention model description
Eligible patients with Stage III Grade B periodontitis and intrabony defects will be randomly assigned to the study groups in a parallel design to evaluate minimally invasive non-surgical therapy with or without the proposed pinhole regenerative
Eligibility
Sex/Gender
ALL
Age
39 Years to 61 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients aged 39-61 years. * Systemically healthy patients. * Diagnosed with Stage III periodontitis. * Presence of probing pocket depth (PPD) ≥ 6 mm. * Presence of clinical attachment loss (CAL) ≥ 4 mm. * Presence of at least one 2- or 3-wall interproximal intrabony defect with: * Defect depth ≥ 3 mm. * Angulation width ≥ 45°. * Each participant contributed one maxillary or mandibular single- or multi-rooted interproximal intrabony defect.
Exclusion criteria
* Patients with any systemic condition contraindicating surgical intervention. * Pregnant or lactating females. * Smokers. * Alcoholic patients. * History of periodontal therapy within the previous 6 months. * History of antibiotic administration within the previous 6 months. * Patients with unacceptable oral hygiene after re-evaluation following Step 1 and Step 2 periodontal therapy. * Teeth with any degree of mobility.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Clinical Outcome | 9 months | Composite outcome of pocket closure ≤4 mm, clinical attachment level ,gain ≥3 mm, and absence of bleeding on probing . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Probing Pocket Depth | Base line ( day one ), and at nine months | Change in probing pocket depth measured using a University of North Carolina periodontal probe. Scale: 1 -10 mm |
| Clinical Attachment Level (CAL) | Base line ( day one ), and at nine months | Change in clinical attachment level measured using a university of north carolina-15 periodontal probe. Scale: 1 -10 mm |
| Patient Satisfaction (Postoperative Pain) | Immediately after surgery, Day 1, Day 2, and Day 3 | Postoperative pain assessed using a 10-cm Visual Analog Scale . |
| Operation Chair Time | During the Intervention | Duration of the operative procedure recorded in minutes. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORMahmoud taha eldestawy, Profesor
Alazhar
Outcome results
None listed