Emdogain and Straumann Bone Ceramic in Infrabony Defects

NCT00906776 | Terminated Results

• 1 other identifier: CR 01/05
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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-wide intrabony defects

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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)

  Baseline and 12 months

• Change in Clinical Attachment Level (CAL)

  Baseline and 6 months

• Change in Probing Pocket Depth (PPD)

  Baseline and 6 months

• Change in Distance Between the Cementum-enamel-junction and the Base of the Vertical Bone Defect

  Baseline and 12 months

Study Arms (2)

Emdogain PLUS

ACTIVE COMPARATOR

Straumann Emdogain in combination with Straumann BoneCeramic

Device: Emdogain PLUS

Autogenous bone

ACTIVE COMPARATOR

Autogenous bone from the patient

Device: Autogenous bone

Interventions

Emdogain PLUS DEVICE

Emdogain treatment followed by Straumann Bone Ceramic application during periodontal surgery

Emdogain PLUS

Autogenous bone DEVICE

Autogenous bone application during periodontal surgery

Autogenous bone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Straumann AG: lead

Study Sites (1)

Hôtel-Dieu, Université Paris 7 Denis Diderot

Paris, 75006, France

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Prof Philippe Bouchard
• Organization: Rotschild hospital

phbouch@noos.fr

+33614656947

Study Officials

• Philippe Bouchard, Prof

  Rotschild Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2009
• First Posted: May 21, 2009
• Study Start: April 1, 2007
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: May 9, 2016
• Results First Posted: October 31, 2012

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)