Evaluation of NIPSA Using Alloplastic Bone Graft and Cross-Linked Hyaluronic Acid in theTreatment of Intrabony Defects

NCT07737678 | Not Yet Recruiting Phase 1

• 1 other identifier: MS.26.01.141
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Sixty patients will be selected from the outpatient clinic in the Oral Medicine and Periodontology Department, Faculty of Dentistry, Mansoura University, Egypt, according to preoperative clinical and radiographic data that will be used to evaluate the bone destruction pattern.

Conditions

Intrabony Periodontal Defect; Periodontal Disease

Outcome Measures

Primary Outcomes (1)

• The primary outcomes of this study are: Bone Fill.

  Bone Fill.

  6 months

Secondary Outcomes (1)

• The Secondary outcomes of this study are: 1. Reduction in Periodontal pocket depth (PPD). 2. Changes in clinical attachment loss (CAL).

  6 months

Study Arms (3)

Non-Incised Papillae Surgical Approach (NIPSA) with Alloplast bone graft (EthOss bone graft)

ACTIVE COMPARATOR

Twenty participants will receive the Non-Incised Papillae Surgical Approach (NIPSA) with Alloplast bone graft (EthOss bone graft) for the treatment of periodontal intrabony defects. Clinical and radiographic outcomes will be evaluated during follow-up.

Device: allopastic bone graft; Procedure: Non-Incised Papillae Surgical Approach

NIPSA with Cross-linked hyaluronic acid

ACTIVE COMPARATOR

Twenty participants will receive the Non-Incised Papillae Surgical Approach (NIPSA) with cross-linked hyaluronic acid for periodontal treatment . Clinical and radiographic outcomes will be evaluated during follow-up.

Drug: cross-linked hyaluronic acid; Procedure: Non-Incised Papillae Surgical Approach

NIPSA with alloplastic bone graft + Cross-linked hyaluronic acid

ACTIVE COMPARATOR

Twenty participants will receive the Non-Incised Papillae Surgical Approach (NIPSA) with a combination of alloplast bone graft and cross-linked hyaluronic acid. The combined regenerative approach will be compared with the two active comparator groups.

Device: allopastic bone graft; Drug: cross-linked hyaluronic acid; Procedure: Non-Incised Papillae Surgical Approach

Interventions

allopastic bone graft DEVICE

A fully synthetic bone graft material composed of beta-tricalcium phosphate and calcium sulfate used to promote bone regeneration in periodontal intrabony defects.

NIPSA with alloplastic bone graft + Cross-linked hyaluronic acid; Non-Incised Papillae Surgical Approach (NIPSA) with Alloplast bone graft (EthOss bone graft)

cross-linked hyaluronic acid DRUG

Cross-linked hyaluronic acid applied to enhance periodontal wound healing and support regenerative outcomes.

NIPSA with Cross-linked hyaluronic acid; NIPSA with alloplastic bone graft + Cross-linked hyaluronic acid

Non-Incised Papillae Surgical Approach PROCEDURE

A minimally invasive periodontal regenerative surgical technique that preserves the interdental papilla and marginal soft tissues while providing access to the intrabony defect through an apical incision.

NIPSA with Cross-linked hyaluronic acid; NIPSA with alloplastic bone graft + Cross-linked hyaluronic acid; Non-Incised Papillae Surgical Approach (NIPSA) with Alloplast bone graft (EthOss bone graft)

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range: 35 to 65 years old.
• Patients diagnosed with stage III. Periodontitis
• Presence of isolated intrabony defect with PPD ≥ 6 mm, CAL ≥ 6 mm
• Intrabony defect depth ≥3 mm.
• Contained an intrabony defect, 3-wall intrabony defect.
• No periodontal treatment has been administered in the previous six months.
• Full-mouth plaque score ≤ 10%.
• Full-mouth bleeding score ≤ 10%. -

You may not qualify if:

• Smokers ≥ 10 cigarettes per day
• Patient with systemic disease.
• Pregnant or lactating patients.
• Patient who has traumatic occlusion.
• Noncompliant patient.
• Patient with multi-rooted teeth with class II \& III furcation involvement.

Sponsors & Collaborators

• Mansoura University: lead

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Mohammed B Alodiani

  Faculty of Dentistry, Mansoura University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammed B Alodiani

CONTACT

00966599951116; m.balodiani@gmai.com

Jilan M Youssef, Professor

CONTACT

0120120060050; jilan_youssef@mans.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Evaluation of Non-Incised Papillae Surgical Approach Using Alloplastic Bone Graft and Cross-Linked Hyaluronic Acid in the Treatment of Intrabony Defects (A Randomized Controlled Clinical Trial)

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 30, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share