BridgeMD
New treatment option for Intra-bony Pockets
Official title Biologicals in Management of Intra-Bony Defects
ClinicalTrials.gov ID: NCT07292870
What this study is testing
What is Minimally invasive surgical treatment of the intra-bony defects?
Minimally invasive surgical treatment of the intra-bony defects is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for intra-bony pockets.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join 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)
You likely can't join 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 treatment Trial with an investigational medicinal product (IMP) or device
- Known or suspected current malignancy
- History of chemotherapy
See the full eligibility 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
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Vlaams Brabant, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Vlaams Brabant, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.