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

NCT ID: NCT01614925

Last Updated: 2020-12-01

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-10-31

Brief 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.

Detailed 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

Conditions

Periodontal Attachment Loss; Periodontal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Emdogain

Periodontal surgery with the additional use of Straumann® Emdogain

Group Type: EXPERIMENTAL

Emdogain

Intervention Type: DEVICE

Periodontal surgery with the additional use of Straumann® Emdogain

Periodontal Surgery

Periodontal surgery alone

Group Type: ACTIVE_COMPARATOR

Periodontal surgery

Intervention Type: PROCEDURE

Periodontal surgery alone

Interventions

Emdogain

Periodontal surgery with the additional use of Straumann® Emdogain

Intervention Type: DEVICE

Periodontal surgery

Periodontal surgery alone

Intervention Type: PROCEDURE

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

• 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

• Subjects with an osseous defect with an intrabony component of ≥2 mm or involving furcation involvement ≥ class II at the tooth of interest

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Straumann AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

CR 02/11

Identifier Type: -

Identifier Source: org_study_id