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Bone Substitutes and NIPSA in Intrabony Periodontal Defects: A Randomized Controlled Trial

ConditionsPeriodontitis (Stage 3)Minimally Invasive Surgical ProceduresBone Substitutes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Belgrade

About this trial

This multicenter randomized controlled clinical trial aims to compare the clinical, radiographic, microbiological and molecular outcomes of two collagenated xenogeneic bone substitutes (GTO® and GenOs®) used in combination with the Non-Incised Papilla Surgical Approach (NIPSA) for the treatment of intrabony periodontal defects. The study will evaluate whether differences exist between the two biomaterials with respect to clinical attachment gain, defect resolution, wound healing and biological markers of regeneration.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥ 18 years

Diagnosis of Stage III periodontitis

At least one intrabony periodontal defect with probing depth > 5 mm following completion of non-surgical periodontal therapy

Full-mouth plaque score (FMPS) < 20%

Disqualifiers

Systemic medical contraindications to periodontal surgery

History of head and neck radiotherapy

Poor oral hygiene or lack of motivation/compliance

Uncontrolled diabetes mellitus

Trial design

Design model

Parallel

Treatments tested in this trial

  • GTO® with NIPSA surgical approach

    Procedure/Surgery

    Regenerative periodontal surgical treatment using the Non-Incised Papilla Surgical Approach (NIPSA) combined with GTO® collagenated xenogeneic bone substitute for the treatment of intrabony periodontal defects.

  • GenOs® + NIPSA

    Procedure/Surgery

    Regenerative periodontal surgical treatment using the Non-Incised Papilla Surgical Approach (NIPSA) combined with GenOs® collagenated xenogeneic bone substitute for the treatment of intrabony periodontal defects.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: GTO® + NIPSAExperimental treatment 1 intervention
Group B: GenOs® + NIPSAActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical Attachment Level (CAL) gain

Change in clinical attachment level (CAL) at treated intrabony periodontal defects from baseline to 6 months following regenerative periodontal therapy using either GTO® or GenOs® in combination with the Non-Incised Papilla Surgical Approach (NIPSA).

Time frame
Baseline to 6 months

Secondary outcomes

1

Probing Depth (PD) reduction

Change in probing depth at treated sites from baseline to 6 months.

Time frame
Baseline to 6 months
2

Bleeding on Probing (BOP)

Change in bleeding on probing (presence/absence) at treated sites from baseline to 6 months.

Time frame
Baseline to 6 months
3

Plaque Index (PI)

Change in plaque index (PI) from baseline to 6 months

Time frame
Baseline to 6 months
4

Radiographic bone level changes

Change in radiographic bone level at treated sites from baseline to 6 months using standardised periapical radiographs.

Time frame
Baseline to 6 months

Other outcomes

Sponsors and contacts

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

University of Belgrade

Lead sponsor

Cittadella Universitaria

Collaborator

Source ClinicalTrials.gov
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