Emdogain and Straumann Bone Ceramic in Infrabony Defects - Full Text View

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 May 16, 2013