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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014