Safety and Efficacy of Periodontal Surgery in Supra-alveolar-type Defects With or Without Straumann® Emdogain

Straumann

Status: Terminated

Conditions: Periodontal Attachment Loss; Periodontal Diseases

Treatments: Procedure: Periodontal surgery; Device: Emdogain

Study type: Interventional

Funder types: Industry

Identifiers

NCT01614925

CR 02/11

Details and patient eligibility

About

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.

Full description

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

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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35 participants in 2 patient groups

Emdogain

Experimental group

Description:

Periodontal surgery with the additional use of Straumann® Emdogain

Treatment:

Device: Emdogain

Periodontal Surgery

Active Comparator group

Description:

Periodontal surgery alone

Treatment:

Procedure: Periodontal surgery