Evaluation of NIPSA Using Alloplastic Bone Graft and Cross-Linked Hyaluronic Acid in theTreatment of Intrabony Defects | NCT07737678

NCT07737678

Overview

NCT ID: NCT07737678
Lead Sponsor: Mansoura UniversityOTHER
Official 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)
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
Interventions

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 30, 2026Actual
Start Date: Aug 1, 2026Estimated
Primary Completion Date: Feb 1, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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%. -

Exclusion Criteria:

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.

Study Plan

Study Type: Interventional
Phase: Phase 1Phase 2
Enrollment: 60Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking

Contacts and Locations

Central Contacts: Mohammed B AlodianiContact
m.balodiani@gmai.com00966599951116 ext. 00201111391937

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Participant Group/Arms

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 acidActive 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

NIPSA with alloplastic bone graft + Cross-linked hyaluronic acidActive 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