Emdogain and Straumann Bone Ceramic in Infrabony Defects

Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00906776
• Other study ID #: CR 01/05
• Status: Terminated
• Phase: N/A
• First received: May 19, 2009
• Last updated: November 20, 2012
• Start date: April 2007
• Est. completion date: July 2012

Study information

• Verified date: November 2012
• Source: Institut Straumann AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Periodontitis

Intervention

Device:
• Emdogain PLUS
Emdogain treatment followed by Straumann Bone Ceramic application during periodontal surgery
• Autogenous bone
Autogenous bone application during periodontal surgery

Locations

Country	Name	City	State
France	Hôtel-Dieu, Université Paris 7 Denis Diderot	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut Straumann AG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in Distance Between the Cementum-enamel-junction and the Base of the Vertical Bone Defect		Baseline and 6 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Change in Distance Between the Cementum-enamel-junction and the Base of the Vertical Bone Defect		Baseline and 12 months	No