Emdogain and Straumann Bone Ceramic in Infrabony Defects

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

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

Study Overview

• Status: Terminated
• Conditions: Periodontitis
• Intervention / Treatment: Device: Emdogain PLUS; Device: Autogenous bone

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75006
    • Hôtel-Dieu, Université Paris 7 Denis Diderot

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Clinical Attachment Level (CAL)	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).	Baseline and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Distance Between the Cementum-enamel-junction and the Base of the Vertical Bone Defect		Baseline and 6 months
Change in Probing Pocket Depth (PPD)	PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket.	Baseline and 12 months
Change in Clinical Attachment Level (CAL)	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).	Baseline and 6 months
Change in Probing Pocket Depth (PPD)	PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket.	Baseline and 6 months
Change in Distance Between the Cementum-enamel-junction and the Base of the Vertical Bone Defect		Baseline and 12 months

Collaborators and Investigators

• Sponsor: Institut Straumann AG
• Investigators: Principal Investigator: Philippe Bouchard, Prof, Rotschild Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: May 19, 2009
• First Submitted That Met QC Criteria: May 20, 2009
• First Posted (Estimate): May 21, 2009

Study Record Updates

• Last Update Posted (Estimate): May 9, 2016
• Last Update Submitted That Met QC Criteria: April 4, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: CR 01/05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No