Two bone graft materials with enamel matrix derivative to regenerate one- and two-wall periodontal bone defects

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with periodontitis and a qualifying one- or two-wall intrabony defect undergo microsurgical flap elevation and receive enamel matrix derivative plus one of two bone substitutes. The two interventions compared are collagenated deproteinized bovine bone mineral granules (BioOss Collagen) versus a resorbable hydroxyapatite–collagen matrix (Ossix Bone). The primary outcome is change in probing depth at 12 months, measured from the gingival margin to the base of the pocket. Eligible participants are adults (≥18 years) in good general health who have completed initial periodontal therapy and have an intrabony defect of ≥3 mm; the trial is conducted at a single center in Milan.

Why it matters

Who can join: the full rules

Inclusion 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 component of equal or more than 3 mm, as diagnosed by periapical radiographs and clinical evaluation (excluding third molars and distal of second molars); the defect must not affect the vestibular / buccal or the lingual support bone wall (PPD lingual or vestibular / buccal \<= 3.5 mm ) of the affected teeth.
* 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.

Exclusion Criteria:

* 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

Where it's running

• IRCCS Ospedale Galeazzi-Sant'Ambrogio
  Milan, Italy Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.