Intra-bony PocketsNCT07292870
Biologicals in Management of Intra-Bony Defects
A study testing Minimally invasive surgical treatment of the intra-bony defects, Use of the xenograft Bio-Oss® Collagen during the surgery and Use of enamel matrix derivative (Emdogain®) in people with Intra-bony Pockets and Periodontitis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intra-bony Pockets, Periodontitis
- What is being tested?
- Minimally invasive surgical treatment of the intra-bony defects, Use of the xenograft Bio-Oss® Collagen during the surgery and Use of enamel matrix derivative (Emdogain®)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Aug 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZLeuven, Campus St. Raphaël, Department Oral Health Sciences, Periodontology
Leuven, Vlaams Brabant, 3000
Lieve Desmet, secretary, +32 16 332407, lieve.desmet@kuleuven.be
Ana Castro, Professor, +32 16 332816, ana.castro@uzleuven.be
About this study
Official title: 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.
Read the 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
- Conditions
- Intra-bony Pockets, Periodontitis
- Being tested
- Minimally invasive surgical treatment of the intra-bony defects, Use of the xenograft Bio-Oss® Collagen during the surgery, Use of enamel matrix derivative (Emdogain®), Use of hyaluronic acid (REGENFAST®), use of the blood derivative L-PRF (leukocyte and platelet rich fibrin)
- Keywords
- Intra-bony defects, periodontitis, minimally invasive surgery, biologicals, L-PRF, Hyaluronic acid, enamel matrix derivative, leukocyte- and platelet-rich fibrin
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive surgical treatment of the intra-bony defectsBiological
A surgical procedure is performed under local anaesthesia in which one of the biomaterials will be used to fill the intra-bony defect.
Use of the xenograft Bio-Oss® Collagen during the surgeryBiological
The clinician will use Bio-Oss® Collagen as adjuvant in the surgical treatment of the intra-bony defects in conjunction with minimally invasive surgery
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.
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
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.
| Study group | Role | What they receive |
|---|---|---|
| Bio-Oss® collagen + Emdogain® | Placebo comparator | minimally invasive surgery + Bio-Oss® collagen + Emdogain® (MIS + BO + Enamel Matrix Derivative) Receives: 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) Receives: 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) Receives: 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) Receives: Biological: Minimally invasive surgical treatment of the intra-bony defects; Biological: use of the blood derivative L-PRF (leukocyte and platelet rich fibrin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative changes in clinical attachment level (CAL)
difference between the baseline and 6/12 months after the surgery measured in mm
Measured: 6/12 months after surgery
Secondary outcomes (3)
Post-operative changes in probing pocket depth (PPD)
difference between the baseline and 6/12 months after the surgery measured in mm
Measured: 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
Measured: 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
Measured: 6/12 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start8 Aug 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-bony PocketsStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana Castro, Professor, Principal investigator, UZLeuven, department of Oral Health Sciences, Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292870
- Sponsor's protocol ID
- S69198
- Status last verified
- Oct 2025
- First submitted
- 18 Nov 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Addition of Different Biologicals in the Surgical Treatment of Periodontal Intra-Bony Defects: A Randomised Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT07292870
- Acronym / sponsor ID
- S69198
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 8 Aug 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bio-Oss® collagen + Emdogain® | Placebo comparator | 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®)minimally invasive surgery + Bio-Oss® collagen + Emdogain® (MIS + BO + Enamel Matrix Derivative) |
| Bio-Oss® collagen + REGENFAST® | Active comparator | 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®)minimally invasive surgery + Bio-Oss® collagen + REGENFAST® (MIS + BO + hyaluronic acid) |
| Bio-Oss® collagen + L-PRF | Active comparator | 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)minimally invasive surgery + Bio-Oss® collagen + L-PRF (MIS + BO + Leucocyte -Platelet Rich Fibrin) |
| L-PRF | Active comparator | Biological: Minimally invasive surgical treatment of the intra-bony defects, Biological: use of the blood derivative L-PRF (leukocyte and platelet rich fibrin)minimally invasive surgery + L-PRF (MIS + Leucocyte-Platelet Rich Fibrin) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally invasive surgical treatment of the intra-bony defectsA surgical procedure is performed under local anaesthesia in which one of the biomaterials will be used to fill the intra-bony defect. | Biological | Bio-Oss® collagen + Emdogain®, Bio-Oss® collagen + L-PRF, Bio-Oss® collagen + REGENFAST®, L-PRF |
| Use of the xenograft Bio-Oss® Collagen during the surgeryThe clinician will use Bio-Oss® Collagen as adjuvant in the surgical treatment of the intra-bony defects in conjunction with minimally invasive surgery | Biological | Bio-Oss® collagen + Emdogain®, Bio-Oss® collagen + L-PRF, Bio-Oss® collagen + REGENFAST® |
| 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. | Biological | Bio-Oss® collagen + Emdogain® |
| 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 | Biological | Bio-Oss® collagen + REGENFAST® |
| 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. | Biological | Bio-Oss® collagen + L-PRF, L-PRF |
Primary outcome
Post-operative changes in clinical attachment level (CAL)
Time frame: 6/12 months after surgery
difference between the baseline and 6/12 months after the surgery measured in mm
3 secondary outcomes
Post-operative changes in probing pocket depth (PPD)
Time frame: 6/12 months after the surgery
Post-operative changes in papilla height (preservation of soft tissues)
Time frame: 6/12 months after the surgery
Post-operative changes in intra-bony defect morphology
Time frame: 6/12 months after the surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Intra-bony Pockets
Enrolling by invitation
Treatment of Periodontal Intrabony Defects With Liquid Platelet-Rich Fibrin Mixed With Denaturated Albumin Gel (ALB_PRF)
Periodontal Bone Loss, Periodontitis Stage III
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ana Castro, Professor principal investigator
UZLeuven, department of Oral Health Sciences, Periodontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally invasive surgical treatment of the intra-bony defects, Use of the xenograft Bio-Oss® Collagen during the surgery and Use of enamel matrix derivative (Emdogain®) in people with Intra-bony Pockets and Periodontitis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana B Castro Sarda, Professor (+32 16 332816, ana.castro@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative changes in clinical attachment level (CAL) (time frame: 6/12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.