Emdogain and Straumann Bone Ceramic in Infrabony Defects

NCT ID: NCT00906776

Last Updated: 2016-05-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2012-07-31

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.

Conditions

Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Emdogain PLUS

Straumann Emdogain in combination with Straumann BoneCeramic

Group Type: ACTIVE_COMPARATOR

Emdogain PLUS

Intervention Type: DEVICE

Emdogain treatment followed by Straumann Bone Ceramic application during periodontal surgery

Autogenous bone

Autogenous bone from the patient

Group Type: ACTIVE_COMPARATOR

Autogenous bone

Intervention Type: DEVICE

Autogenous bone application during periodontal surgery

Interventions

Emdogain PLUS

Emdogain treatment followed by Straumann Bone Ceramic application during periodontal surgery

Intervention Type: DEVICE

Autogenous bone

Autogenous bone application during periodontal surgery

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Straumann AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe Bouchard, Prof

Role: PRINCIPAL_INVESTIGATOR

Rotschild Hospital

Locations

Hôtel-Dieu, Université Paris 7 Denis Diderot

Paris, , France

Countries

France

Other Identifiers

CR 01/05

Identifier Type: -

Identifier Source: org_study_id