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

Primary Purpose

Periodontal Attachment Loss, Periodontal Diseases

Status
Terminated
Phase
Locations
United States
Study Type
Interventional
Intervention
Emdogain
Periodontal surgery
Sponsored by
Institut Straumann AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Attachment Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Emdogain

Periodontal Surgery

Arm Description

Periodontal surgery with the additional use of Straumann® Emdogain

Periodontal surgery alone

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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)
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
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.
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.
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.

Full Information

First Posted
June 6, 2012
Last Updated
November 5, 2020
Sponsor
Institut Straumann AG
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1. Study Identification

Unique Protocol Identification Number
NCT01614925
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
Due to change in strategy and decision not to expand indication.
Study Start Date
November 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Straumann AG

4. Oversight

Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Attachment Loss, Periodontal Diseases

7. Study Design

Primary Purpose
Treatment
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Emdogain
Arm Type
Experimental
Arm Description
Periodontal surgery with the additional use of Straumann® Emdogain
Arm Title
Periodontal Surgery
Arm Type
Active Comparator
Arm Description
Periodontal surgery alone
Intervention Type
Device
Intervention Name(s)
Emdogain
Intervention Description
Periodontal surgery with the additional use of Straumann® Emdogain
Intervention Type
Procedure
Intervention Name(s)
Periodontal surgery
Intervention Description
Periodontal surgery alone
Primary Outcome Measure Information:
Title
Clinical Attachment Level
Description
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.
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Change in Gingival Margin (GM) From Baseline to 12 Months
Description
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.
Time Frame
12 months after baseline
Title
Change in Probing Pocket Depth (PPD) From Baseline to 12 Months
Description
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.
Time Frame
12 months after baseline
Title
Early Wound Healing Index (EHI) Assessment at 4 Weeks After Baseline
Description
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)
Time Frame
4 weeks after baseline
Title
Comparison of Post-surgical Pain at 4 Weeks After Baseline
Description
Visual Analog Scale (VAS) for post-surgical pain, minimum value=0, maximum value=10, higher score means worse outcome
Time Frame
4 weeks after baseline
Title
Change in Bleeding on Probing (BoP) From Baseline to 12 Months
Description
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.
Time Frame
12 months after baseline
Title
Change in Root Dentin Hypersensitivity (RDH) From Baseline to 12 Months
Description
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.
Time Frame
12 months after baseline
Title
Change in Plaque Index (PI) From Baseline to 12 Months
Description
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.
Time Frame
12 months after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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