Periodontal Intrabony DefectsPRTNCT07763223
Sub-junctional Pinhole Technique
A study testing Sub-junctional Pinhole Technique (S-PHT) in people with Periodontal Intrabony Defects and Stage III Grade B Periodontitis, run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 39 to 61 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Intrabony Defects, Stage III Grade B Periodontitis
- What is being tested?
- Sub-junctional Pinhole Technique (S-PHT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2024to 27 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 39 to 61 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
Show all 9Show fewer
- Defect depth ≥ 3 mm.
- Angulation width ≥ 45°.
- Each participant contributed one maxillary or mandibular single- or multi-rooted interproximal intrabony defect.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Periodontology, Faculty of Dentistry, Al-Azhar University, Cairo, Egypt
Cairo, Nasr City, 11675
About this study
Official title: A Novel Approach of Pinhole Regenerative Therapy (PRT) in Treating Stage III Periodontitis
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
Read the 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.
- Being tested
- Sub-junctional Pinhole Technique (S-PHT)
- Keywords
- Stage III Periodontitis, Pinhole Regenerative Therapy (PRT), Periodontal Regeneration, Periodontal Therapy
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sub-junctional Pinhole Technique (S-PHT)Procedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Sub-junctional Pinhole Technique (S-PHT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Clinical Outcome
Composite outcome of pocket closure ≤4 mm, clinical attachment level ,gain ≥3 mm, and absence of bleeding on probing .
Measured: 9 months
Secondary outcomes (4)
Probing Pocket Depth
Change in probing pocket depth measured using a University of North Carolina periodontal probe.
Scale: 1 -10 mm
Measured: 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
Measured: Base line ( day one ), and at nine months
Patient Satisfaction (Postoperative Pain)
Postoperative pain assessed using a 10-cm Visual Analog Scale .
Measured: Immediately after surgery, Day 1, Day 2, and Day 3
Operation Chair Time
Duration of the operative procedure recorded in minutes.
Measured: During the Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start30 Jun 2024
- Primary completion25 Apr 2025
- Study completion27 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal Intrabony DefectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mahmoud eldestawy, Al-Azhar University
- Investigators
- Mahmoud taha eldestawy, Profesor, Principal investigator, Alazhar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763223
- Sponsor's protocol ID
- PRT-RCT-2026-001
- Acronym
- PRT
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Approach of Pinhole Regenerative Therapy (PRT) in Treating Stage III Periodontitis
- ClinicalTrials.gov ID
- NCT07763223
- Acronym / sponsor ID
- PRT / PRT-RCT-2026-001
- Keywords
- Stage III Periodontitis, Pinhole Regenerative Therapy (PRT), Periodontal Regeneration, Periodontal Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 25 Apr 2025 (actual)
- Study completion
- 27 Dec 2025 (actual)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Sub-junctional Pinhole Technique (S-PHT) | Experimental | Procedure: Sub-junctional Pinhole Technique (S-PHT)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 |
Who may qualify
- Ages
- 39 to 61 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (8 listed)
- Patients with any systemic condition contraindicating surgical intervention.
- Pregnant or lactating females.
- Smokers.
- Alcoholic patients.
- History of periodontal therapy within the previous 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sub-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 | Procedure or surgery | Sub-junctional Pinhole Technique (S-PHT) |
Primary outcome
Composite Clinical Outcome
Time frame: 9 months
Composite outcome of pocket closure ≤4 mm, clinical attachment level ,gain ≥3 mm, and absence of bleeding on probing .
4 secondary outcomes
Probing Pocket Depth
Time frame: Base line ( day one ), and at nine months
Clinical Attachment Level (CAL)
Time frame: Base line ( day one ), and at nine months
Patient Satisfaction (Postoperative Pain)
Time frame: Immediately after surgery, Day 1, Day 2, and Day 3
Operation Chair Time
Time frame: During the Intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Periodontal Intrabony Defects
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Minimally Invasive Non-Surgical Therapy Versus Single Flap Approach in Management of Periodontal Intrabony Defects
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Treatment of Intrabony Defects With Injectable Platelet-Rich Fibrin and Xenogenic Grafts
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Alb-PRF as an Adjunct to Regenerative Periodontal Surgery
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Minimally Invasive Non-Surgical Periodontal Therapy Alone vs. Minimally Invasive Non-Surgical Periodontal Therapy With I-PRF With or Without Chlorhexidine on Stage III Periodontitis Patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud taha eldestawy, Profesor principal investigator
Alazhar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sub-junctional Pinhole Technique (S-PHT) in people with Periodontal Intrabony Defects and Stage III Grade B Periodontitis, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Clinical Outcome (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.