Emdogain and Straumann Bone Ceramic in Infrabony Defects

Straumann

Status

Terminated

Conditions

Periodontitis

Treatments

Device: Emdogain PLUS

Device: Autogenous bone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00906776

CR 01/05

Details and patient eligibility

About

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

Full 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.

Enrollment

19 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.