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

NCT07671963 | Recruiting

• 1 other identifier: 36/53
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Periodontitis (Stage 3); Bone Substitutes; Minimally Invasive Surgical Procedures

Keywords

periodontitis; regenerative treatment; NIPSA; bone substitutes

Outcome Measures

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).

  Baseline to 6 months

Secondary Outcomes (10)

• Probing Depth (PD) reduction

  Baseline to 6 months

• Bleeding on Probing (BOP)

  Baseline to 6 months

• Plaque Index (PI)

  Baseline to 6 months

• Radiographic bone level changes

  Baseline to 6 months

• Quantification of periodontal pathogens

  Baseline to 6 months

Study Arms (2)

GTO® + NIPSA

EXPERIMENTAL

Regenerative periodontal therapy using GTO® collagenated xenogeneic bone substitute in combination with the Non-Incised Papilla Surgical Approach (NIPSA).

Procedure: GTO® with NIPSA surgical approach

GenOs® + NIPSA

ACTIVE COMPARATOR

Regenerative periodontal therapy using GenOs® collagenated xenogeneic bone substitute in combination with the Non-Incised Papilla Surgical Approach (NIPSA).

Procedure: GenOs® + NIPSA

Interventions

GTO® with NIPSA surgical approach PROCEDURE

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.

GTO® + NIPSA

GenOs® + NIPSA PROCEDURE

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.

GenOs® + NIPSA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%
• Full-mouth bleeding score (FMBS) \< 20%
• Ability to understand the study procedures and provide written informed consent

You may not qualify if:

• Systemic medical contraindications to periodontal surgery
• History of head and neck radiotherapy
• Poor oral hygiene or lack of motivation/compliance
• Uncontrolled diabetes mellitus
• Pregnancy or lactation
• Treatment with antiresorptive medications or other drugs affecting bone remodeling
• Heavy smoking (\>20 cigarettes/day)

Sponsors & Collaborators

• University of Belgrade: lead
• Cittadella Universitaria: collaborator

Study Sites (2)

Department of Periodontology, School of Dental Medicine, University of Cagliari Cittadella Universitaria di Monserrato Monserrato (CA), Italy

Cagliari, Italy, Italy

RECRUITING

Department of Periodontology and Research Implant Center, School of Dental Medicine, University of Belgrade

Belgrade, Serbia

RECRUITING

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Iva Z Milinkovic, DDS, PhD

  School of Dental Medicine, University of Belgrade, Implant Research Centre and Department of Periodontology and Oral Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iva Z Milinkovic, DDS, PhD

CONTACT

+381113629201; iva.milinkovic@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly assigned in a 1:1 ratio to receive regenerative periodontal therapy using either GTO® or GenOs® in combination with the Non-Incised Papilla Surgical Approach (NIPSA) for the treatment of intrabony periodontal defects.

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 26, 2026

Record last verified: 2026-06

Locations

IT (1); SE (1)