Biologicals in Management of Intra-Bony Defects

NCT07292870 | Recruiting

• 1 other identifier: S69198
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intra-bony Pockets; Periodontitis

Keywords

Intra-bony defects; periodontitis; minimally invasive surgery; biologicals; L-PRF; Hyaluronic acid; enamel matrix derivative; leukocyte- and platelet-rich fibrin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  6/12 months after the surgery

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

  6/12 months after the surgery

• Post-operative changes in intra-bony defect morphology

  6/12 months after the surgery

Study Arms (4)

Bio-Oss® collagen + Emdogain®

PLACEBO COMPARATOR

minimally invasive surgery + Bio-Oss® collagen + Emdogain® (MIS + BO + Enamel Matrix Derivative)

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®)

Bio-Oss® collagen + REGENFAST®

ACTIVE COMPARATOR

minimally invasive surgery + Bio-Oss® collagen + REGENFAST® (MIS + BO + hyaluronic acid)

Biological: Minimally invasive surgical treatment of the intra-bony defects; Biological: Use of the xenograft Bio-Oss® Collagen during the surgery; Biological: Use of hyaluronic acid (REGENFAST®)

Bio-Oss® collagen + L-PRF

ACTIVE COMPARATOR

minimally invasive surgery + Bio-Oss® collagen + L-PRF (MIS + BO + Leucocyte -Platelet Rich Fibrin)

Biological: Minimally invasive surgical treatment of the intra-bony defects; Biological: Use of the xenograft Bio-Oss® Collagen during the surgery; Biological: use of the blood derivative L-PRF (leukocyte and platelet rich fibrin)

L-PRF

ACTIVE COMPARATOR

minimally invasive surgery + L-PRF (MIS + Leucocyte-Platelet Rich Fibrin)

Biological: Minimally invasive surgical treatment of the intra-bony defects; Biological: use of the blood derivative L-PRF (leukocyte and platelet rich fibrin)

Interventions

Minimally invasive surgical treatment of the intra-bony defects BIOLOGICAL

A surgical procedure is performed under local anaesthesia in which one of the biomaterials will be used to fill the intra-bony defect.

Bio-Oss® collagen + Emdogain®; Bio-Oss® collagen + L-PRF; Bio-Oss® collagen + REGENFAST®; L-PRF

Use of the xenograft Bio-Oss® Collagen during the surgery BIOLOGICAL

The clinician will use Bio-Oss® Collagen as adjuvant in the surgical treatment of the intra-bony defects in conjunction with minimally invasive surgery

Bio-Oss® collagen + Emdogain®; Bio-Oss® collagen + L-PRF; Bio-Oss® collagen + REGENFAST®

Use of enamel matrix derivative (Emdogain®) BIOLOGICAL

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.

Bio-Oss® collagen + Emdogain®

Use of hyaluronic acid (REGENFAST®) BIOLOGICAL

The clinician will use hyaluronic acid (REGENFAST®) as adjuvant in the surgical treatment of the intra-bony defects in conjunction with minimally invasive surgery

Bio-Oss® collagen + REGENFAST®

use of the blood derivative L-PRF (leukocyte and platelet rich fibrin) BIOLOGICAL

The clinician will use L-PRF as adjuvant in the surgical treatment of the intra-bony defects in conjunction with minimally invasive surgery.

Bio-Oss® collagen + L-PRF; L-PRF

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZLeuven, Campus St. Raphaël, Department Oral Health Sciences, Periodontology

Leuven, Vlaams Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Periodontitis

Interventions

enamel matrix proteins; Leukocyte Count

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Ana Castro, Professor

  UZLeuven, department of Oral Health Sciences, Periodontology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana B Castro Sarda, Professor

CONTACT

+32 16 332816; ana.castro@uzleuven.be

Lieve Desmet, secretary

CONTACT

+32 16 332407; lieve.desmet@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 18, 2025
• Study Start: August 8, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 17, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)