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

A Randomized, Controlled, Multicenter Clinical Study Evaluating the Outcomes of Periodontal Surgery in Supra-alveolar-type Defects With or Without Straumann® Emdogain

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.

Study Overview

• Status: Terminated
• Conditions: Periodontal Diseases; Periodontal Attachment Loss
• Intervention / Treatment: Device: Emdogain; Procedure: Periodontal surgery

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

• Study Type: Interventional
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Emdogain; Periodontal surgery with the additional use of Straumann® Emdogain	Device: Emdogain; Periodontal surgery with the additional use of Straumann® Emdogain
Active Comparator: Periodontal Surgery; Periodontal surgery alone	Procedure: Periodontal surgery; Periodontal surgery alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Attachment Level	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.	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Gingival Margin (GM) From Baseline to 12 Months	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.	12 months after baseline
Change in Probing Pocket Depth (PPD) From Baseline to 12 Months	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.	12 months after baseline
Early Wound Healing Index (EHI) Assessment at 4 Weeks After Baseline	Postoperative wound healing was assessed by the EHI according to Wachtel et al. [2003] by visual assessment: complete flap closure - no fibrin line in the interproximal area; complete flap closure - fine fibrin line in the interproximal area; complete flap closure - fibrin clot in the interproximal area; incomplete flap closure - partial necrosis of the interproximal tissue; 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)	4 weeks after baseline
Comparison of Post-surgical Pain at 4 Weeks After Baseline	Visual Analog Scale (VAS) for post-surgical pain, minimum value=0, maximum value=10, higher score means worse outcome	4 weeks after baseline
Change in Bleeding on Probing (BoP) From Baseline to 12 Months	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.	12 months after baseline
Change in Root Dentin Hypersensitivity (RDH) From Baseline to 12 Months	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.	12 months after baseline
Change in Plaque Index (PI) From Baseline to 12 Months	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.	12 months after baseline

Collaborators and Investigators

• Sponsor: Institut Straumann AG

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: June 6, 2012
• First Submitted That Met QC Criteria: June 6, 2012
• First Posted (Estimate): June 8, 2012

Study Record Updates

• Last Update Posted (Actual): December 1, 2020
• Last Update Submitted That Met QC Criteria: November 5, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Atrophy; Periodontal Diseases; Periodontal Attachment Loss
• Other Study ID Numbers: CR 02/11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO