We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Emdogain and Straumann Bone Ceramic in Infrabony Defects

This study has been terminated.
(Difficulty to recruit patients fulfilling inclusion criteria)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00906776
First Posted: May 21, 2009
Last Update Posted: May 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Institut Straumann AG
May 19, 2009
May 21, 2009
August 30, 2012
October 31, 2012
May 9, 2016
April 2007
July 2012   (Final data collection date for primary outcome measure)
Change in Clinical Attachment Level (CAL) [ Time Frame: Baseline and 12 months ]
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 clinical attachment level (CAL) after 12 months [ Time Frame: 12 months ]
Complete list of historical versions of study NCT00906776 on ClinicalTrials.gov Archive Site
  • Change in Distance Between the Cementum-enamel-junction and the Base of the Vertical Bone Defect [ Time Frame: Baseline and 6 months ]
  • Change in Probing Pocket Depth (PPD) [ Time Frame: Baseline and 12 months ]
    PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket.
  • Change in Clinical Attachment Level (CAL) [ Time Frame: Baseline and 6 months ]
    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) [ Time Frame: Baseline and 6 months ]
    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 [ Time Frame: Baseline and 12 months ]
  • Radiographic bone gain [ Time Frame: 6 months and 12 months ]
  • Probing Pocket Depth (PD) [ Time Frame: 6 months and 12 months ]
  • Clinical Attachment Level [ Time Frame: 6 months ]
  • Bleeding on Probing (BOP) [ Time Frame: 6 months and 12 months ]
  • Plaque Index (PI) [ Time Frame: 6 months and 12 months ]
Not Provided
Not Provided
 
Emdogain and Straumann Bone Ceramic in Infrabony Defects
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
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

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Periodontitis
  • Device: Emdogain PLUS
    Emdogain treatment followed by Straumann Bone Ceramic application during periodontal surgery
  • Device: Autogenous bone
    Autogenous bone application during periodontal surgery
  • Active Comparator: Emdogain PLUS
    Straumann Emdogain in combination with Straumann BoneCeramic
    Intervention: Device: Emdogain PLUS
  • Active Comparator: Autogenous bone
    Autogenous bone from the patient
    Intervention: Device: Autogenous bone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
19
July 2012
July 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00906776
CR 01/05
No
Not Provided
Plan to Share IPD: No
Institut Straumann AG
Institut Straumann AG
Not Provided
Principal Investigator: Philippe Bouchard, Prof Rotschild Hospital
Institut Straumann AG
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP