BridgeMD
New treatment option for Periodontitis
Official title The Use of Two Bone Substitutes in Adjunct to EMD for the Treatment of One- and Two-wall Intrabony Defects.
ClinicalTrials.gov ID: NCT07546279
What this study is testing
- What it's testing
- The main aim will be to evaluate the difference in PD changes at 12-month follow-up, measured from the gingival margin to the base of the pocket, comparing periodontal regeneration using two different bone substitutes, that is bovine derived xenograft granules (BioOss® Collagen) and one resorbable sponge-like hydroxyapatite collagen matrix (OssixTM Bone), in adjunct with EMD after microsurgical flap elevation. Inclusion criteria I.
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Men and women over or equal to the age of 18 years
- Patients in general good health in the opinion of the principal investigator as determined by medical history and clinical examination (ASA 1 or...
- Clinical evidence of periodontitis, with one interdental area of PPD (periodontal probing depth) ≥6mm and bleeding on probing, associated one or more...
- Patients who already underwent stage I and stage II of periodontal therapy, as described in the EFP practice guidelines (Sanz et al., 2020), within 6...
- Patients who can understand the requirements of the study and are willing and able to comply with its instructions and schedules
You likely can't join if
- FMPS% \> 15% at the time of recruitment
- FMBS% \> 15% at the time of recruitment
- Treatment with anticoagulant drugs (INR above 2,5)
- Treatment with intravenous bisphosphonates
- Treatment with anticonvulsants drugs
- patients with history of alcohol, narcotics, or drug abuse
See the full eligibility criteria
- Men and women over or equal to the age of 18 years
- Patients in general good health in the opinion of the principal investigator as determined by medical history and clinical examination (ASA 1 or ASA-2)
- Clinical evidence of periodontitis, with one interdental area of PPD (periodontal probing depth) ≥6mm and bleeding on probing, associated one or more one-wall or two-wall intrabony periodontal defect with an intrabony...
- Patients who already underwent stage I and stage II of periodontal therapy, as described in the EFP practice guidelines (Sanz et al., 2020), within 6 months prior to assessment for eligibility
- Patients who can understand the requirements of the study and are willing and able to comply with its instructions and schedules
- Patients who had provided written informed consent to participate in the study prior to any study procedure.
- FMPS% \> 15% at the time of recruitment
- FMBS% \> 15% at the time of recruitment
- Treatment with anticoagulant drugs (INR above 2,5)
- Treatment with intravenous bisphosphonates
- Treatment with anticonvulsants drugs
- patients with history of alcohol, narcotics, or drug abuse
- Patients receiving radiotherapy, chemotherapy, or any other immunosuppressive treatment or who have been administered radiotherapy in the last 5 years
- Patients through at any time received radiotherapy to the head and neck region will be excluded anyway
- Uncontrolled bleeding disorders such as: hemophilia, thrombocytopenia, granulocytopenia
- Degenerative diseases
- Osteoradionecrosis
- Renal failure
- Organ transplant recipients
- HIV positive (self-declaration)
- Malignant diseases
- Diseases that compromise the immune system
- Unbalanced diabetes. (HbA1c above 7.2 assessed by self-declaration)
- Psychotic diseases
- Hypersensitivity or specific contraindications to one of the components of any of the products used in the study
- Women who are pregnant (self-declaration); or lactating at the time of recruitment and of surgery
- Site where a history of failed periodontal regenerative procedure in the last two years
- Heavy Smokers (5 cigarettes and more per day)
- Other uncontrolled systemic diseases
- disorders or treatments that compromise wound healing
- chronic high dose steroid therapy
- bone metabolic diseases
The study team makes the final eligibility decision.
Where it's taking place
- Milan, Italy
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 study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milan, Italy. 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.