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Emdogain and Straumann Bone Ceramic in Infrabony Defects

Primary Purpose

Periodontitis

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Emdogain PLUS
Autogenous bone
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

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males and females must be at least 18 years and not more than 75 years of age
  • The patient will have to be able to understand and sign the informed consent prior to starting the study.
  • The patient also will have to have the ability and the willingness to comply with all study requirements.
  • The patients will be in good general health without any systemic diseases.
  • The teeth included in the study will be mandibular molars, maxillary and mandibular premolars, and canines.
  • The patients will have to have at least one defect with pocket depth ≥ 5 mm.
  • Intra-bony defects will have to have 1 or 2-wall morphology (at least 2/3 of the defect).
  • Depth of the intrabony component of at least 3 mm
  • The selected sites will have to have vertical intra-bony component ≥ 3 mm and an angle ≥ 30 degrees as assessed from standardized intra-oral radiographs.
  • Oral hygiene parameters: Plaque Index (PI) ≤ 20 % and bleeding on probing (BoP) ≤ 20%

Exclusion Criteria:

  • Heavy smokers: more than 20 cigarettes per day
  • Mucosal diseases such as erosive lichen planus
  • History of local radiation therapy
  • Presence of oral lesions (such as ulceration, malignancy)
  • Teeth with untreated endodontic or cardiologic problems
  • Physical handicap that will interfere with patient's ability to exercise good oral hygiene on a regular basis.
  • Patients presenting antibiotic treatment within the 3 months preceding the surgical procedure.
  • Patients using anti-inflammatory drugs on a regular basis.
  • Intra-bony defects with a 3-wall morphology.
  • Intra-bony defects with furcation involvement.
  • Incisors and maxillary molars, will be excluded.
  • Alcoholism or chronically drug abuse causing systemic compromize
  • Medical conditions requiring prolonged use of steroids
  • Current pregnancy at the time of recruitment and/or breastfeeding women.
  • Conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for surgical procedure or would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability.

Sites / Locations

  • Hôtel-Dieu, Université Paris 7 Denis Diderot

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Emdogain PLUS

Autogenous bone

Arm Description

Straumann Emdogain in combination with Straumann BoneCeramic

Autogenous bone from the patient

Outcomes

Primary Outcome Measures

Change in Clinical Attachment Level (CAL)
CAL is calculated as the sum of Probing Pocket Depth (PPD) and Recession (REC). PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket. REC is measured using a periodontal probe from the gingival margin to the cemento-enamel junction (CEJ).

Secondary Outcome Measures

Change in Distance Between the Cementum-enamel-junction and the Base of the Vertical Bone Defect
Change in Probing Pocket Depth (PPD)
PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket.
Change in Clinical Attachment Level (CAL)
CAL is calculated as the sum of Probing Pocket Depth (PPD) and Recession (REC). PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket. REC is measured using a periodontal probe from the gingival margin to the cemento-enamel junction (CEJ).
Change in Probing Pocket Depth (PPD)
PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket.
Change in Distance Between the Cementum-enamel-junction and the Base of the Vertical Bone Defect

Full Information

First Posted
May 19, 2009
Last Updated
April 4, 2016
Sponsor
Institut Straumann AG
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1. Study Identification

Unique Protocol Identification Number
NCT00906776
Brief Title
Emdogain and Straumann Bone Ceramic in Infrabony Defects
Official Title
Randomised, Controlled, Clinical Study to Compare the Effect of a Combination of Enamel Matrix Proteins and Straumann Bone Ceramic With Autogenous Bone in Deep-wide Intrabony Defects
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Why Stopped
Difficulty to recruit patients fulfilling inclusion criteria
Study Start Date
April 2007 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (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
Randomised, controlled, clinical study to compare the effect of the combination of bone ceramic and enamel matrix proteins (test) versus autogenous bone graft alone (control) in the treatment of deep-wide intrabony defects
Detailed Description
30 subjects (15 test and 15 control) diagnosed with moderate to severe periodontitis (Armitage, 1999) will be enrolled in the study and randomized to either the test or the control group. The surgical procedure shall be performed within 15 days from the baseline visit of the subjects and will be the same for both groups. In both groups, the flap is replaced subsequently. In total 5 visits per patient are scheduled in this study. The total study duration for each patient should be 12 +/- 2 weeks. The study devices Emdogain® and Straumann Bone Ceramic are CE-marked, and approved by the FDA. One center in France will participate.

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
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Emdogain PLUS
Arm Type
Active Comparator
Arm Description
Straumann Emdogain in combination with Straumann BoneCeramic
Arm Title
Autogenous bone
Arm Type
Active Comparator
Arm Description
Autogenous bone from the patient
Intervention Type
Device
Intervention Name(s)
Emdogain PLUS
Intervention Description
Emdogain treatment followed by Straumann Bone Ceramic application during periodontal surgery
Intervention Type
Device
Intervention Name(s)
Autogenous bone
Intervention Description
Autogenous bone application during periodontal surgery
Primary Outcome Measure Information:
Title
Change in Clinical Attachment Level (CAL)
Description
CAL is calculated as the sum of Probing Pocket Depth (PPD) and Recession (REC). PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket. REC is measured using a periodontal probe from the gingival margin to the cemento-enamel junction (CEJ).
Time Frame
Baseline and 12 months
Secondary Outcome Measure Information:
Title
Change in Distance Between the Cementum-enamel-junction and the Base of the Vertical Bone Defect
Time Frame
Baseline and 6 months
Title
Change in Probing Pocket Depth (PPD)
Description
PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket.
Time Frame
Baseline and 12 months
Title
Change in Clinical Attachment Level (CAL)
Description
CAL is calculated as the sum of Probing Pocket Depth (PPD) and Recession (REC). PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket. REC is measured using a periodontal probe from the gingival margin to the cemento-enamel junction (CEJ).
Time Frame
Baseline and 6 months
Title
Change in Probing Pocket Depth (PPD)
Description
PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket.
Time Frame
Baseline and 6 months
Title
Change in Distance Between the Cementum-enamel-junction and the Base of the Vertical Bone Defect
Time Frame
Baseline and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females must be at least 18 years and not more than 75 years of age The patient will have to be able to understand and sign the informed consent prior to starting the study. The patient also will have to have the ability and the willingness to comply with all study requirements. The patients will be in good general health without any systemic diseases. The teeth included in the study will be mandibular molars, maxillary and mandibular premolars, and canines. The patients will have to have at least one defect with pocket depth ≥ 5 mm. Intra-bony defects will have to have 1 or 2-wall morphology (at least 2/3 of the defect). Depth of the intrabony component of at least 3 mm The selected sites will have to have vertical intra-bony component ≥ 3 mm and an angle ≥ 30 degrees as assessed from standardized intra-oral radiographs. Oral hygiene parameters: Plaque Index (PI) ≤ 20 % and bleeding on probing (BoP) ≤ 20% Exclusion Criteria: Heavy smokers: more than 20 cigarettes per day Mucosal diseases such as erosive lichen planus History of local radiation therapy Presence of oral lesions (such as ulceration, malignancy) Teeth with untreated endodontic or cardiologic problems Physical handicap that will interfere with patient's ability to exercise good oral hygiene on a regular basis. Patients presenting antibiotic treatment within the 3 months preceding the surgical procedure. Patients using anti-inflammatory drugs on a regular basis. Intra-bony defects with a 3-wall morphology. Intra-bony defects with furcation involvement. Incisors and maxillary molars, will be excluded. Alcoholism or chronically drug abuse causing systemic compromize Medical conditions requiring prolonged use of steroids Current pregnancy at the time of recruitment and/or breastfeeding women. Conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for surgical procedure or would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Bouchard, Prof
Organizational Affiliation
Rotschild Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôtel-Dieu, Université Paris 7 Denis Diderot
City
Paris
ZIP/Postal Code
75006
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Emdogain and Straumann Bone Ceramic in Infrabony Defects

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