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Emdogain Minimally Invasive Surgical Technique

Primary Purpose

Periodontitis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Scaling and root planing
Scaling and root planing without Emdogain
Emdogain application
Sponsored by
Institut Straumann AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subjects must have voluntarily signed the informed consent form before any study related procedures
  • Subjects must be males or females who are 18-85 years of age
  • Subjects must have moderate to severe chronic, generalized periodontitis with pockets of 5 mm - 8mm probing depth in at least 2 pockets per contralateral quadrants in one arch (study teeth)
  • 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

Exclusion Criteria:

  • Subjects taking or intending to take any medications during the duration of the study that will potentially affect healing and inflammation
  • Subjects who are currently heavy smokers (defined >10 cigarettes per day or >1 cigar per day) or who use chewing tobacco
  • Subjects being treated with systemic antibiotics or subjects that were treated with systemic antibiotics within 3 months prior to treatment in this study
  • Subjects with uncontrolled diabetes
  • Subjects that are immunocompromised or immunosuppressed
  • Subjects that cannot provide informed consent
  • Subjects with drug or alcohol abuse
  • Subjects that have undergone periodontal root planing or periodontal surgery in the last 6 months
  • Subjects that are pregnant
  • Subjects with necrotizing periodontitis or periodontitis related to systemic disease
  • Teeth with pockets with probing depth ≥ 9 mm will not classify as study teeth
  • Teeth with pockets or defects with furcation involvement will not classify as study teeth
  • Teeth with mobility degree > 1 without splint will not classify as study teeth
  • Subjects with test and control sites in the two quadrants on adjacent teeth
  • Patients with compromised health conditions such as diabetes, systemic diseases, high dose steroid therapy, bone metabolic diseases, radiation or immune-oppressive therapy, and infections or vascular impairment at the surgical site
  • Subjects with conditions or circumstances, in the opinion of the Investigator , which would prevent completion of study participation or interfere with analysis of study results

Sites / Locations

  • Periodontal and Implant Associates, Inc.
  • Periodontics and Implant Dentistry
  • Clinique Paro Excellence
  • Universitätsmedizin der Johannes Gutenberg Universität Mainz

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Test (with Emdogain)

Control (without Emdogain)

Arm Description

Scaling and root planing with Emdogain

Scaling and root planing without Emdogain

Outcomes

Primary Outcome Measures

Change in Clinical Attachment Levels (CAL)
CAL will be measured in millimeters on the study teeth at 6 locations. Outcome is mean change of CAL from baseline measurements at surgery to 12-months post-surgery, taken from the deepest pocket of a patient's test and control teeth measured at baseline. Analysis will compare the mean change of CAL for test and control treatment arms.

Secondary Outcome Measures

Change in Gingival Margin (GM)
GM will be measured in millimeters on the study teeth at 6 locations. Outcome is mean change of GM from baseline at surgery to 12-months-post surgery, taken from the deepest pocket of a patient's test and control teeth measured at baseline. Analysis will compare the mean change of GM for test and control treatment arms.
Change in Pocket Probing Depth (PPD)
PPD will be measured in millimeters on the study teeth in 6 locations. Outcome is mean change of PPD from baseline at surgery to 12-months post-surgery, taken from the deepest pocket of a patient's test and control teeth at baseline. Analysis will compare the mean change of PPD for test and control treatment arms.
Change in Full Mouth Plaque Score (FMPS)
FMPS will be calculated based on the number of tooth surfaces with plaque over the total number of tooth surfaces x 100. The value is presented as a percent. The difference in FMPS between 12 months and baseline will be determined.
Change in Bleeding on Probing (BoP)
For the categorical variable BoP, the frequency of bleeding (present or absent) will be counted (absolute and in percent) over all measured sites around the identified study teeth for each treatment group. The results will be compared between the 12-month follow-up and baseline.
Change in Root Dentin Hypersensitivity
Presence of root dentin hypersensitivity will be recorded as "none" (no reaction from the subject), "mild" (sensible with no pain), "moderate" (sensible with slight pain), or "severe" (sensible with pain that persists for a while) after a conventional air blast is applied to the study tooth. Changes in the frequency of categories will be determined and compared between the two treatment arms. An improvement is defined as a decreased reaction (for example, severe to mild), a deterioration is defined as increased reaction (for example, none to moderate), and unchanged is no change to reaction (for example, mild to mild).
Change in Post-surgical Pain
Post-surgical pain will be measured on a 100 millimeter visual analog scale. The range is 0 (no pain) to 99 (nearly maximum pain). The lower the value, the better the outcome. The subjects will be instructed to mark their level of pain on a line for both the test quadrant and the control quadrant. The average change in pain level will be determined and compared between the two arms.

Full Information

First Posted
September 14, 2015
Last Updated
October 16, 2019
Sponsor
Institut Straumann AG
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1. Study Identification

Unique Protocol Identification Number
NCT02551770
Brief Title
Emdogain Minimally Invasive Surgical Technique
Official Title
Straumann® Emdogain® Application In Conjunction With Minimally Invasive Surgical Technique For Periodontal Disease Treatment: A Split-Mouth Design Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this controlled study is to assess the clinical outcomes and patient reported outcomes of using minimally invasive surgical procedure with Straumann Emdogain as an adjunct (test treatment) or without Straumann Emdogain (control treatment).
Detailed Description
The aim of the study will be achieved through the following primary and secondary objectives. The primary objective is to evaluate the regenerative potential of Straumann Emdogain by comparing the change in clinical attachment level from baseline to 12 months between the test and control arms. The regenerative potential of Straumann Emdogain will also be assessed by comparing the changes in gingival margins, changes in average probing pocket depth, changes in full mouth plaque score, changes in bleeding on probing, and changes in root dentin hypersensitivity from baseline to 12 months between the test and control arms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test (with Emdogain)
Arm Type
Active Comparator
Arm Description
Scaling and root planing with Emdogain
Arm Title
Control (without Emdogain)
Arm Type
Other
Arm Description
Scaling and root planing without Emdogain
Intervention Type
Procedure
Intervention Name(s)
Scaling and root planing
Intervention Description
Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw.
Intervention Type
Procedure
Intervention Name(s)
Scaling and root planing without Emdogain
Intervention Description
Using minimally invasive surgical procedure (scaling and root planing) without Emdogain application to treat one contra-lateral quadrant in subject's jaw.
Intervention Type
Device
Intervention Name(s)
Emdogain application
Intervention Description
Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw
Primary Outcome Measure Information:
Title
Change in Clinical Attachment Levels (CAL)
Description
CAL will be measured in millimeters on the study teeth at 6 locations. Outcome is mean change of CAL from baseline measurements at surgery to 12-months post-surgery, taken from the deepest pocket of a patient's test and control teeth measured at baseline. Analysis will compare the mean change of CAL for test and control treatment arms.
Time Frame
Baseline and 12 Month Follow-Up Visit
Secondary Outcome Measure Information:
Title
Change in Gingival Margin (GM)
Description
GM will be measured in millimeters on the study teeth at 6 locations. Outcome is mean change of GM from baseline at surgery to 12-months-post surgery, taken from the deepest pocket of a patient's test and control teeth measured at baseline. Analysis will compare the mean change of GM for test and control treatment arms.
Time Frame
Baseline and 12 Month Follow-Up Visit
Title
Change in Pocket Probing Depth (PPD)
Description
PPD will be measured in millimeters on the study teeth in 6 locations. Outcome is mean change of PPD from baseline at surgery to 12-months post-surgery, taken from the deepest pocket of a patient's test and control teeth at baseline. Analysis will compare the mean change of PPD for test and control treatment arms.
Time Frame
Baseline and 12 Month Follow-Up Visit
Title
Change in Full Mouth Plaque Score (FMPS)
Description
FMPS will be calculated based on the number of tooth surfaces with plaque over the total number of tooth surfaces x 100. The value is presented as a percent. The difference in FMPS between 12 months and baseline will be determined.
Time Frame
Baseline and 12 Month Follow-Up Visit
Title
Change in Bleeding on Probing (BoP)
Description
For the categorical variable BoP, the frequency of bleeding (present or absent) will be counted (absolute and in percent) over all measured sites around the identified study teeth for each treatment group. The results will be compared between the 12-month follow-up and baseline.
Time Frame
Baseline and 12 Month Follow-Up Visit
Title
Change in Root Dentin Hypersensitivity
Description
Presence of root dentin hypersensitivity will be recorded as "none" (no reaction from the subject), "mild" (sensible with no pain), "moderate" (sensible with slight pain), or "severe" (sensible with pain that persists for a while) after a conventional air blast is applied to the study tooth. Changes in the frequency of categories will be determined and compared between the two treatment arms. An improvement is defined as a decreased reaction (for example, severe to mild), a deterioration is defined as increased reaction (for example, none to moderate), and unchanged is no change to reaction (for example, mild to mild).
Time Frame
Baseline and 12 Month Follow-Up Visit
Title
Change in Post-surgical Pain
Description
Post-surgical pain will be measured on a 100 millimeter visual analog scale. The range is 0 (no pain) to 99 (nearly maximum pain). The lower the value, the better the outcome. The subjects will be instructed to mark their level of pain on a line for both the test quadrant and the control quadrant. The average change in pain level will be determined and compared between the two arms.
Time Frame
1-2 days post surgery, 1 week post surgery, and 2 weeks post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects must have voluntarily signed the informed consent form before any study related procedures Subjects must be males or females who are 18-85 years of age Subjects must have moderate to severe chronic, generalized periodontitis with pockets of 5 mm - 8mm probing depth in at least 2 pockets per contralateral quadrants in one arch (study teeth) 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 Exclusion Criteria: Subjects taking or intending to take any medications during the duration of the study that will potentially affect healing and inflammation Subjects who are currently heavy smokers (defined >10 cigarettes per day or >1 cigar per day) or who use chewing tobacco Subjects being treated with systemic antibiotics or subjects that were treated with systemic antibiotics within 3 months prior to treatment in this study Subjects with uncontrolled diabetes Subjects that are immunocompromised or immunosuppressed Subjects that cannot provide informed consent Subjects with drug or alcohol abuse Subjects that have undergone periodontal root planing or periodontal surgery in the last 6 months Subjects that are pregnant Subjects with necrotizing periodontitis or periodontitis related to systemic disease Teeth with pockets with probing depth ≥ 9 mm will not classify as study teeth Teeth with pockets or defects with furcation involvement will not classify as study teeth Teeth with mobility degree > 1 without splint will not classify as study teeth Subjects with test and control sites in the two quadrants on adjacent teeth Patients with compromised health conditions such as diabetes, systemic diseases, high dose steroid therapy, bone metabolic diseases, radiation or immune-oppressive therapy, and infections or vascular impairment at the surgical site Subjects with conditions or circumstances, in the opinion of the Investigator , which would prevent completion of study participation or interfere with analysis of study results
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela K McClain, DDS
Organizational Affiliation
Periodontics and Implant Dentistry
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Veronique Benhamou, DDS
Organizational Affiliation
Clinique Paro Excellence
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jennifer H Doobrow, DMD
Organizational Affiliation
Periodontal & Implant Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Periodontal and Implant Associates, Inc.
City
Cullman
State/Province
Alabama
ZIP/Postal Code
35055
Country
United States
Facility Name
Periodontics and Implant Dentistry
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012-3202
Country
United States
Facility Name
Clinique Paro Excellence
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3B 3A7
Country
Canada
Facility Name
Universitätsmedizin der Johannes Gutenberg Universität Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Emdogain Minimally Invasive Surgical Technique

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