Clinical trial NCT01614925: Safety and Efficacy of Periodontal Surgery in Supra-alveolar-type Defects With or Without Straumann® Emdogain
Official title: A Randomized, Controlled, Multicenter Clinical Study Evaluating the Outcomes of Periodontal Surgery in Supra-alveolar-type Defects With or Without Straumann® Emdogain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Conditions: Periodontal Attachment Loss
Periodontal Diseases
Lead sponsor: Institut Straumann AG
Sponsor class: INDUSTRY
First posted: 2012-06-08
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Clinical Attachment Level
timeFrame: 12 Months
Secondary outcomes:
measure: Change in Gingival Margin (GM) From Baseline to 12 Months
timeFrame: 12 months after baseline
measure: Change in Probing Pocket Depth (PPD) From Baseline to 12 Months
timeFrame: 12 months after baseline
measure: Early Wound Healing Index (EHI) Assessment at 4 Weeks After Baseline
timeFrame: 4 weeks after baseline
measure: Comparison of Post-surgical Pain at 4 Weeks After Baseline
timeFrame: 4 weeks after baseline
measure: Change in Bleeding on Probing (BoP) From Baseline to 12 Months
timeFrame: 12 months after baseline
measure: Change in Root Dentin Hypersensitivity (RDH) From Baseline to 12 Months
timeFrame: 12 months after baseline
measure: Change in Plaque Index (PI) From Baseline to 12 Months
timeFrame: 12 months after baseline
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References: