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Completed

NCT Number: NCT07763223

Sub-junctional Pinhole Technique

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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Key information

Age range

39 year–61 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Cairo, Nasr City, 11675, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Composite Clinical Outcome

    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).

Secondary outcomes

  1. Probing Pocket Depth

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

    Change in probing pocket depth measured using a UNC-15 periodontal probe

  2. Clinical Attachment Level (CAL)

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

    Change in clinical attachment level measured using a UNC-15 periodontal probe.

  3. Patient Satisfaction (Postoperative Pain)

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

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

  4. Operation Chair Time

    Time frame: During the Intervention

    Duration of the operative procedure recorded in minutes.

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

A Novel Approach of Pinhole Regenerative Therapy (PRT) in Treating Stage III Periodontitis

Acronym: PRT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 13, 2026
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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