NCT07763223

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 5, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 13, 2026

Completed
Last Updated

August 13, 2026

Status Verified

August 1, 2026

Enrollment Period

10 months

First QC Date

August 5, 2026

Last Update Submit

August 11, 2026

Conditions

Keywords

Stage III PeriodontitisPinhole Regenerative Therapy (PRT)Periodontal RegenerationPeriodontal Therapy

Outcome Measures

Primary Outcomes (1)

  • Composite Clinical Outcome

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

    9 months

Secondary Outcomes (4)

  • Probing Pocket Depth

    Base line ( day one ), and at nine months

  • Clinical Attachment Level (CAL)

    Base line ( day one ), and at nine months

  • Patient Satisfaction (Postoperative Pain)

    Immediately after surgery, Day 1, Day 2, and Day 3

  • Operation Chair Time

    During the Intervention

Study Arms (1)

Sub-junctional Pinhole Technique (S-PHT)

EXPERIMENTAL

Participants with Stage III periodontitis and intrabony defects received minimally invasive non-surgical periodontal therapy (MINST), followed 4 weeks later by sub-junctional pinhole technique (S-PHT), including minimally invasive defect degranulation and xenogenic bone graft placement through a facial pinhole without flap elevation

Procedure: Sub-junctional Pinhole Technique (S-PHT)

Interventions

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

Sub-junctional Pinhole Technique (S-PHT)

Eligibility Criteria

Age39 Years - 61 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Cairo, Nasr City, 11675, Egypt

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Mahmoud taha eldestawy, Profesor

    Alazhar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
No masking was used in this case series. All participants received the same intervention, and no blinding of participants or investigators was performed
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 5, 2026

First Posted

August 13, 2026

Study Start

June 30, 2025

Primary Completion

April 25, 2026

Study Completion

June 27, 2026

Last Updated

August 13, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations