Department of Periodontology, Faculty of Dentistry, Al-Azhar University, Cairo, Egypt
Cairo, Nasr City, 11675, Egypt
NCT Number: NCT07763223
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
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Notify Me39 year–61 year
All sexes
Interventional
Not applicable
Cairo, Nasr City, 11675, Egypt
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 9 months
Composite outcome of pocket closure ≤4 mm, clinical attachment level (CAL) gain ≥3 mm, and absence of bleeding on probing (BOP).
Time frame: Base line ( day one ), and at nine months
Change in probing pocket depth measured using a UNC-15 periodontal probe
Time frame: Base line ( day one ), and at nine months
Change in clinical attachment level measured using a UNC-15 periodontal probe.
Time frame: Immediately after surgery, Day 1, Day 2, and Day 3
Postoperative pain assessed using a 10-cm Visual Analog Scale (VAS).
Time frame: During the Intervention
Duration of the operative procedure recorded in minutes.
Al-Azhar University
Other
A Novel Approach of Pinhole Regenerative Therapy (PRT) in Treating Stage III Periodontitis
Acronym: PRT
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