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

Terminated

Conditions: Periodontal Attachment Loss
Periodontal Diseases

Interventions: Device: Emdogain
Procedure: Periodontal surgery

Registration Number: NCT01614925

Lead Sponsor: Institut Straumann AG

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

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 35

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Emdogain	Emdogain	Periodontal surgery with the additional use of Straumann® Emdogain
Periodontal Surgery	Periodontal surgery	Periodontal surgery alone

Primary Outcome Measures

Name	Time	Method
Clinical Attachment Level	12 Months	The change in Clinical Attachment Level (CAL) from Baseline to 12 Months. CAL measurements will be derived from the Probing Pocket Depth (PPD) and Gingival Margin (GM) measurements as follows: CAL = PPD - GM.

Secondary Outcome Measures

Name	Time	Method
Change in Plaque Index (PI) From Baseline to 12 Months	12 months after baseline	The PI was recorded according to O'Leary et al. \[1972\] as a binary response at the mesial, distal, facial and lingual surfaces on the study teeth. The percentage of positive events per total sites was calculated for each group. The outcome measure was the change between baseline and 12 months. Negative values indicate a decrease in PI.
Change in Gingival Margin (GM) From Baseline to 12 Months	12 months after baseline	GM was measured by recording the distance from the Cemento-Enamel Junction (CEJ) to the margin of the gingiva at 6 sites (mesio-vestibular, mid-vestibular, disto-vestibular, mesio-oral, mid-oral, disto-oral) on the study teeth. Negative value for GM indicates gingival recession. A positive value for the GM indicates the gingiva was covering the CEJ.
Comparison of Post-surgical Pain at 4 Weeks After Baseline	4 weeks after baseline	Visual Analog Scale (VAS) for post-surgical pain, minimum value=0, maximum value=10, higher score means worse outcome
Change in Bleeding on Probing (BoP) From Baseline to 12 Months	12 months after baseline	The presence of BoP was recorded as a binary response on 6 sites (mesio-vestibular, midvestibular, disto-vestibular, mesio-oral, mid-oral, and disto-oral) on the study teeth. The percentage of positive events per total probing sites was calculated for each group. The outcome measure was the change between baseline and 12 months. Negative values indicate a decrease in BoP.
Change in Probing Pocket Depth (PPD) From Baseline to 12 Months	12 months after baseline	PPD was measured before the area is anaesthetized by recording the distance from the gingival margin to the bottom of the probable pocket at 6 sites (mesio-vestibular, mid-vestibular, disto-vestibular, mesiooral, mid-oral, and disto-oral) on the study teeth.Negative value for PPD indicates reduction of pocket depth.
Early Wound Healing Index (EHI) Assessment at 4 Weeks After Baseline	4 weeks after baseline	Postoperative wound healing was assessed by the EHI according to Wachtel et al. \[2003\] by visual assessment: 1. complete flap closure - no fibrin line in the interproximal area 2. complete flap closure - fine fibrin line in the interproximal area 3. complete flap closure - fibrin clot in the interproximal area 4. incomplete flap closure - partial necrosis of the interproximal tissue 5. incomplete flap closure - complete necrosis of the interproximal tissue The outcome measure was the percentage of EHI category 1 (complete flap closure - no fibrin line in the interproximal area)
Change in Root Dentin Hypersensitivity (RDH) From Baseline to 12 Months	12 months after baseline	RDH was examined by physical testing using cold air as a stimulus. The percentage of positive events per total testing sites was calculated for each group. The outcome measure was the change between baseline and 12 months. Negative values indicate a decrease in RDH.