BioOss Collagen vs Ossix Bone, EMD, 12-Month Periodontal Trial, Apr 22
ClinicalTrials.gov Studies
Summary
NCT07546279 is a randomized controlled trial comparing two bone substitute materials — bovine-derived xenograft granules (BioOss Collagen) and a resorbable hydroxyapatite collagen matrix (Ossix Bone) — used adjunctively with enamel matrix derivative (EMD) for periodontal regeneration in one- and two-wall intrabony defects. The study plans a 12-month follow-up measuring pocket depth reduction as the primary endpoint, enrolling adults aged 18+ with clinical evidence of periodontitis and PPD ≥6 mm with bleeding on probing and an intrabony component ≥3 mm.
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This ClinicalTrials.gov record registers a prospective, randomized, single-center trial evaluating periodontal regeneration outcomes using two distinct bone substitute materials as adjuncts to enamel matrix derivative (EMD) following microsurgical flap elevation. The primary efficacy measure is the change in periodontal probing depth from gingival margin to base of pocket at 12 months post-procedure. Both interventions — collagenated deproteinized bovine bone mineral (BioOss Collagen) and hydroxyapatite collagen matrix (Ossix Bone) — are resorbable bone graft substitutes commonly used in periodontology. Participating patients must be systemically healthy adults with documented periodontitis who have completed prior phase I and phase II periodontal therapy within six months of eligibility assessment.
For dental clinicians, researchers, and medical device manufacturers, this trial represents a head-to-head comparison of two widely used bone substitute categories in a controlled clinical setting. Neither the trial sponsor nor the participating institution is named in the registration record; however, the specific inclusion criteria (PPD ≥6 mm, ≥3 mm intrabony component, ASA 1 or 2 classification) define a clearly delineated patient population. No compliance obligations or regulatory deadlines arise from this trial registration for third parties.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
The Use of Two Bone Substitutes in Adjunct to EMD for the Treatment of One- and Two-wall Intrabony Defects.
N/A NCT07546279 Kind: NA Apr 22, 2026
Abstract
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. Men and women over or equal to the age of 18 years II. 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) III. 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.
IV. 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 V. Patients who can understand the requirements of the study and are willing and able to comply with its instructions and...
Conditions: Periodontitis, Bone Defects
Interventions: EMD + collagenated DBBM, EMD + hydroxyapatite collagen matrix
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