Emdogain and Straumann Bone Ceramic in Infrabony Defects

This study has been terminated.
(Difficulty to recruit patients fulfilling inclusion criteria)
Sponsor:
Information provided by (Responsible Party):
Institut Straumann AG
ClinicalTrials.gov Identifier:
NCT00906776
First received: May 19, 2009
Last updated: November 20, 2012
Last verified: November 2012
  Purpose

To compare the clinical 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


Condition Intervention
Periodontitis
Device: Emdogain PLUS
Device: Autogenous bone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by Institut Straumann AG:

Primary Outcome Measures:
  • Change in Clinical Attachment Level (CAL) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Change in Probing Pocket Depth (PPD) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: April 2007
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Emdogain PLUS
Straumann Emdogain in combination with Straumann BoneCeramic
Device: Emdogain PLUS
Emdogain treatment followed by Straumann Bone Ceramic application during periodontal surgery
Active Comparator: Autogenous bone
Autogenous bone from the patient
Device: Autogenous bone
Autogenous bone application during periodontal surgery

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00906776

Locations
France
Hôtel-Dieu, Université Paris 7 Denis Diderot
Paris, France, 75006
Sponsors and Collaborators
Institut Straumann AG
Investigators
Principal Investigator: Philippe Bouchard, Prof Rotschild Hospital
  More Information

No publications provided

Responsible Party: Institut Straumann AG
ClinicalTrials.gov Identifier: NCT00906776     History of Changes
Other Study ID Numbers: CR 01/05
Study First Received: May 19, 2009
Results First Received: August 30, 2012
Last Updated: November 20, 2012
Health Authority: France: Institutional Ethical Committee

Additional relevant MeSH terms:
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on April 16, 2014