PeriodontitisNCT00906776
Emdogain and Straumann Bone Ceramic in Infrabony Defects
A study testing Emdogain PLUS and Autogenous bone in people with Periodontitis, run by Institut Straumann AG at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- Emdogain PLUS and Autogenous bone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2007to Jul 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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%
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Periodontitis
- Being tested
- Emdogain PLUS, Autogenous bone
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emdogain PLUSDevice
Emdogain treatment followed by Straumann Bone Ceramic application during periodontal surgery
Autogenous boneDevice
Autogenous bone application during periodontal surgery
| Study group | Role | What they receive |
|---|---|---|
| Emdogain PLUS | Active comparator | Straumann Emdogain in combination with Straumann BoneCeramic Receives: Device: Emdogain PLUS |
| Autogenous bone | Active comparator | Autogenous bone from the patient Receives: Device: Autogenous bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and 12 months
Secondary outcomes (5)
Change in Distance Between the Cementum-enamel-junction and the Base of the Vertical Bone Defect
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline and 6 months
Change in Distance Between the Cementum-enamel-junction and the Base of the Vertical Bone Defect
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startApr 2007
- Primary completionJul 2012
- Study completionJul 2012
Why it stopped: Difficulty to recruit patients fulfilling inclusion criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Straumann AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe Bouchard, Prof, Principal investigator, Rotschild Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906776
- Sponsor's protocol ID
- CR 01/05
- Status last verified
- Apr 2016
- First submitted
- 19 May 2009
- Last updated
- 9 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00906776
- Acronym / sponsor ID
- CR 01/05
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty to recruit patients fulfilling inclusion criteria
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Institut Straumann AGIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 21 May 2009 (estimated)
- Results
- Posted 31 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emdogain PLUS | Active comparator | Device: Emdogain PLUSStraumann Emdogain in combination with Straumann BoneCeramic |
| Autogenous bone | Active comparator | Device: Autogenous boneAutogenous bone from the patient |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emdogain PLUSEmdogain treatment followed by Straumann Bone Ceramic application during periodontal surgery | Device | Emdogain PLUS |
| Autogenous boneAutogenous bone application during periodontal surgery | Device | Autogenous bone |
Primary outcome
Change in Clinical Attachment Level (CAL)
Time frame: Baseline and 12 months
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).
5 secondary outcomes
Change in Distance Between the Cementum-enamel-junction and the Base of the Vertical Bone Defect
Time frame: Baseline and 6 months
Change in Probing Pocket Depth (PPD)
Time frame: Baseline and 12 months
Change in Clinical Attachment Level (CAL)
Time frame: Baseline and 6 months
Change in Probing Pocket Depth (PPD)
Time frame: Baseline and 6 months
Change in Distance Between the Cementum-enamel-junction and the Base of the Vertical Bone Defect
Time frame: Baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Bouchard, Prof principal investigator
Rotschild Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emdogain PLUS and Autogenous bone in people with Periodontitis, run by Institut Straumann AG at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinical Attachment Level (CAL) (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2016.