Health TrialsbyHealthPanel

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

ConditionsIntrabony Periodontal DefectPeriodontal Disease
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age35-65
SponsorMansoura University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Smokers ≥ 10 cigarettes per day

Patient with systemic disease.

Pregnant or lactating patients.

Patient who has traumatic occlusion.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • cross-linked hyaluronic acid

    Drug

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

  • Non-Incised Papillae Surgical Approach

    Procedure/Surgery

    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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Non-Incised Papillae Surgical Approach (NIPSA) with Alloplast bone graft (EthOss bone graft)Active comparator 2 interventions
Group B: NIPSA with Cross-linked hyaluronic acidActive comparator 2 interventions
Group C: NIPSA with alloplastic bone graft + Cross-linked hyaluronic acidActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

The primary outcomes of this study are: Bone Fill.

Bone Fill.

Time frame
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).

1. Decrease in Periodontal pocket depth (PPD). 2. Changes in clinical attachment loss (CAL)

Time frame
6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mansoura University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: