Sub-junctional Pinhole Technique

Al-Azhar University10 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

Conditions

Periodontal Intrabony Defects Stage III Grade B Periodontitis

Interventions

Sub-junctional Pinhole Technique (S-PHT)PROCEDURE

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

Eligibility

Sex: ALLMin age: 39 YearsMax age: 61 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Department of Periodontology, Faculty of Dentistry, Al-Azhar University, Cairo, Egypt

Cairo, Nasr City, Egypt

Outcomes

Primary Outcomes

Composite Clinical Outcome

Composite outcome of pocket closure ≤4 mm, clinical attachment level ,gain ≥3 mm, and absence of bleeding on probing .

Time frame: 9 months

Secondary Outcomes

Probing Pocket Depth

Change in probing pocket depth measured using a University of North Carolina periodontal probe. Scale: 1 -10 mm

Time frame: Base line ( day one ), and at nine months

Clinical Attachment Level (CAL)

Change in clinical attachment level measured using a university of north carolina-15 periodontal probe. Scale: 1 -10 mm

Time frame: Base line ( day one ), and at nine months

Patient Satisfaction (Postoperative Pain)

Postoperative pain assessed using a 10-cm Visual Analog Scale .

Time frame: Immediately after surgery, Day 1, Day 2, and Day 3

Operation Chair Time

Duration of the operative procedure recorded in minutes.

Time frame: During the Intervention

Data from ClinicalTrials.gov

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