safety and efficacy of periodontal surgery in supra-alveolar-type defects with or without straumann® emdogain

Conditions: Periodontal Attachment Loss; Periodontal Diseases

Summary: the primary objective of this study is to demonstrate that in supra-alveolar-type defects (i.e., defects displaying a predominately horizontal pattern of bone loss), periodontal surgery with the additional use of straumann® emdogain will result in significantly higher clinical attachment level (cal) gain compared to periodontal surgery without straumann® emdogain.

the following secondary endpoints will be evaluated during the study: * change in gingival margin (gm) at 12 months after surgery compared to baseline * change in probing pocket depth (ppd) at 12 months after surgery compared to baseline * comparison of early wound healing index (ehi) at 4 weeks after surgery between treatment groups * comparison of post-surgical pain at 4 weeks after surgery between treatment groups * change in bleeding on probing (bop) at 12 months after surgery compared to baseline * change in root dentin hypersensitivity at 12 months after surgery compared to baseline * change in full mouth plaque index (pi) at 12 months after surgery compared to baseline

Eligibility criteria:
inclusion criteria: * subjects must have advanced periodontitis: * presence of supra-alveolar-type defects (i.e., defects displaying a predominantly horizontal pattern of bone loss) at a minimum of two adjacent teeth and a maximum of 7 adjacent teeth (fdi positions 17-27 or 37-47) in either the maxilla or the mandible with a ppd of ≥6 mm at a minimum on one site of the examined teeth * teeth must have \< class ii mobility * teeth must have horizontal bone loss with an intrabony component of \<2 mm as defined by radiographic evaluation * subjects must have adequate oral hygiene (full mouth plaque index (pi) of \<25% at baseline (i.e., following initial non-surgical periodontal therapy) * subjects must have adequate control of inflammation (full mouth bleeding on probing (fmbp) of \<25% at baseline (i.e., following initial non-surgical periodontal therapy) * subjects must have voluntarily signed the informed consent form before any study related procedures * subjects must be males and females of at least 18 years of age * subjects must be committed to the study and the required follow-up visits * subjects must be in good general health as assessed by the investigator at time of surgery exclusion criteria: pre-surgical exclusion criteria: * subjects with any contraindications for oral surgical procedures * subjects with uncontrolled diabetes or other uncontrolled systemic diseases * subjects with disorders or treatments that compromise wound healing * subjects with medical conditions requiring chronic high dose steroid therapy * subjects with bone metabolic diseases * subjects with radiation or other immuno-oppressive therapy * subjects with infections or vascular impairment at the surgical site * subjects who are on antibiotic treatment or chronic anti-inflammatory treatment (≥3 times per week) within 4 weeks prior to surgery. * subjects with the presence of oral lesions (such as ulceration, malignancy) * subjects with mucosal diseases (e.g., lichen planus, mouth ulcer) * subjects with a history of malignant disease in the oral cavity or previous radiotherapy to the head or neck * subjects with inadequate oral hygiene or unmotivated for adequate home care * subjects that have been treated with an investigational drug or device within the 30 day period immediately prior to surgery on study day 0. * subjects who currently smoke * female subjects who are nursing, pregnant, or plan to become pregnant secondary exclusion criteria: * subjects with an osseous defect with an intrabony component of ≥2 mm or involving furcation involvement ≥ class ii at the tooth of interest