Biologicals in Management of Intra-Bony Defects

Evaluation of the Addition of Different Biologicals in the Surgical Treatment of Periodontal Intra-Bony Defects: A Randomised Controlled Clinical Trial.

The aim is of this study is to evaluate and compare the effects (clinical and radiological) of different biomaterials on the repair of bone defects around the teeth. When participating in this study, persons will be scheduled for local surgical intervention of the gums. Under local anaesthesia, the gums will be opened minimally to gain insight into the underlying bone defect. After the bone defect has been made completely free of inflammation, they will be randomly assigned to one of the groups below and the biomaterials for this group will be used to fill the defect around your teeth. The different biomaterials are artificial bone + amelogenin; artificial bone + hyaluronic acid; artificial bone + blood preparation (L-PRF) or blood preparation alone.

Then the gums will be closed again with a suture and they will receive the necessary instructions regarding the procedure.

Study Overview

• Status: Recruiting
• Conditions: Periodontitis; Intra-bony Pockets
• Intervention / Treatment: Biological: Minimally invasive surgical treatment of the intra-bony defects; Biological: Use of the xenograft Bio-Oss® Collagen during the surgery; Biological: Use of enamel matrix derivative (Emdogain®); Biological: Use of hyaluronic acid (REGENFAST®); Biological: use of the blood derivative L-PRF (leukocyte and platelet rich fibrin)

Detailed Description

The purpose of this study is to assess the clinical and radiological effectiveness of hyaluronic acid (REGENFAST®), enamel matrix derivative (Emdogain®), and platelet concentrates (L-PRF) in the surgical treatment (minimally invasive technique) of intra-bony defects in conjunction with minimally invasive surgery..

This is a non-inferiority study. The alternative hypothesis is that the use of hyaluronic acid or L-PRF obtained at least the same treatment outcome (seen as clinical attachment level gain) than the gold standard (use of enamel matrix derivatives).

2.2. Primary Endpoints

Post-operative changes in clinical attachment level (CAL):

• difference between the baseline and 6/12 months after the surgery
• measured in millimetres

2.3. Secondary Endpoints

Post-operative changes in probing pocket depth (PPD):

• difference between the baseline and 6/12 months after the surgery
• measured in millimetres

Post-operative changes in papilla height (preservation of soft tissues):

• difference between the baseline and 6/12 months after the surgery
• measured by means of a volumetric analysis based on intra-oral scan

Post-operative changes in intra-bony defect morphology:

• difference between the baseline and 6/12 months after the surgery
• periapical radiograph (parallel angle technique)
• defect resolution measured in millimetres
• bone fill measured in percentage

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ana B Castro Sarda, Professor; Phone Number: +32 16 332816; Email: ana.castro@uzleuven.be
• Study Contact Backup: Name: Lieve Desmet, secretary; Phone Number: +32 16 332407; Email: lieve.desmet@kuleuven.be

Study Locations

• Belgium
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • Recruiting
      • UZLeuven, Campus St. Raphaël, Department Oral Health Sciences, Periodontology
      • Contact: Lieve Desmet, secretary; Phone Number: +32 16 332407; Email: lieve.desmet@kuleuven.be
      • Contact: Ana Castro, Professor; Phone Number: +32 16 332816; Email: ana.castro@uzleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
• At least 18 years of age at the time of signing the Informed Consent Form (ICF)
• American Society of Anesthesiology (ASA) score I or II
• Has already completed the non-surgical periodontal therapy with remaining local pockets of ≥ 6 mm14
• The intra-bony defect should be non-contained (2-wall defect)
• Clinical indication for surgical treatment of the intra-bony defect with minimally invasive approach in conjunction with biologicals

Exclusion Criteria:

• Under the age of 18 years
• Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
• Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
• Participation in an interventional Trial with an investigational medicinal product (IMP) or device
• Known or suspected current malignancy
• History of chemotherapy
• History of radiation in the head and neck region
• History of other metabolic bone diseases
• Current or previous use of intravenous and oral bisphosphonates
• Haematological disorders
• Pregnancy / lactation
• Smoking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Bio-Oss® collagen + Emdogain®; minimally invasive surgery + Bio-Oss® collagen + Emdogain® (MIS + BO + Enamel Matrix Derivative)	Biological: Minimally invasive surgical treatment of the intra-bony defects; A surgical procedure is performed under local anaesthesia in which one of the biomaterials will be used to fill the intra-bony defect.; Biological: Use of the xenograft Bio-Oss® Collagen during the surgery; The clinician will use Bio-Oss® Collagen as adjuvant in the surgical treatment of the intra-bony defects in conjunction with minimally invasive surgery; Biological: Use of enamel matrix derivative (Emdogain®); The clinician will use Enamel matrix derivative (Emdogain®) as adjuvant in the surgical treatment of the intra-bony defects in conjunction with minimally invasive surgery.
Active Comparator: Bio-Oss® collagen + REGENFAST®; minimally invasive surgery + Bio-Oss® collagen + REGENFAST® (MIS + BO + hyaluronic acid)	Biological: Minimally invasive surgical treatment of the intra-bony defects; A surgical procedure is performed under local anaesthesia in which one of the biomaterials will be used to fill the intra-bony defect.; Biological: Use of the xenograft Bio-Oss® Collagen during the surgery; The clinician will use Bio-Oss® Collagen as adjuvant in the surgical treatment of the intra-bony defects in conjunction with minimally invasive surgery; Biological: Use of hyaluronic acid (REGENFAST®); The clinician will use hyaluronic acid (REGENFAST®) as adjuvant in the surgical treatment of the intra-bony defects in conjunction with minimally invasive surgery
Active Comparator: Bio-Oss® collagen + L-PRF; minimally invasive surgery + Bio-Oss® collagen + L-PRF (MIS + BO + Leucocyte -Platelet Rich Fibrin)	Biological: Minimally invasive surgical treatment of the intra-bony defects; A surgical procedure is performed under local anaesthesia in which one of the biomaterials will be used to fill the intra-bony defect.; Biological: Use of the xenograft Bio-Oss® Collagen during the surgery; The clinician will use Bio-Oss® Collagen as adjuvant in the surgical treatment of the intra-bony defects in conjunction with minimally invasive surgery; Biological: use of the blood derivative L-PRF (leukocyte and platelet rich fibrin); The clinician will use L-PRF as adjuvant in the surgical treatment of the intra-bony defects in conjunction with minimally invasive surgery.
Active Comparator: L-PRF; minimally invasive surgery + L-PRF (MIS + Leucocyte-Platelet Rich Fibrin)	Biological: Minimally invasive surgical treatment of the intra-bony defects; A surgical procedure is performed under local anaesthesia in which one of the biomaterials will be used to fill the intra-bony defect.; Biological: use of the blood derivative L-PRF (leukocyte and platelet rich fibrin); The clinician will use L-PRF as adjuvant in the surgical treatment of the intra-bony defects in conjunction with minimally invasive surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative changes in clinical attachment level (CAL)	difference between the baseline and 6/12 months after the surgery measured in mm	6/12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative changes in probing pocket depth (PPD)	difference between the baseline and 6/12 months after the surgery measured in mm	6/12 months after the surgery
Post-operative changes in papilla height (preservation of soft tissues)	difference between the baseline and 6/12 months after the surgery measured by means of a volumetric analysis based on intra-oral scan	6/12 months after the surgery
Post-operative changes in intra-bony defect morphology	difference between the baseline and 6/12 months after the surgery, via periapical radiograph (parallel angle technique); defect resolution measured in millimetres and bone fill measured in percentage	6/12 months after the surgery

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Ana Castro, Professor, UZLeuven, department of Oral Health Sciences, Periodontology

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: December 5, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: periodontitis; biologicals; Hyaluronic acid; minimally invasive surgery; Intra-bony defects; L-PRF; enamel matrix derivative; leukocyte- and platelet-rich fibrin
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cell Count; Cytological Techniques; Hematologic Tests; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Blood Cell Count; Leukocyte Count; enamel matrix proteins
• Other Study ID Numbers: S69198

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No