Status:
TERMINATED
Emdogain and Straumann Bone Ceramic in Infrabony Defects
Lead Sponsor:
Institut Straumann AG
Conditions:
Periodontitis
Eligibility:
All Genders
18-75 years
Phase:
NA
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-...
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 surgica...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00906776
Start Date
April 1 2007
End Date
July 1 2012
Last Update
May 9 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hôtel-Dieu, Université Paris 7 Denis Diderot
Paris, France, 75006