Periodontitis
Conditions
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
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.
Interventions
DEVICEEmdogain PLUS
Emdogain treatment followed by Straumann Bone Ceramic application during periodontal surgery
DEVICEAutogenous bone
Autogenous bone application during periodontal surgery
Sponsors
Institut Straumann AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Attachment Level (CAL) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket. |
| Change in Clinical Attachment Level (CAL) | Baseline and 6 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). |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Emdogain PLUS Straumann Emdogain in combination with Straumann BoneCeramic | 11 |
| Autogenous Bone Autogenous bone from the patient | 8 |
| Total | 19 |
Baseline characteristics
| Characteristic | Emdogain PLUS | Autogenous Bone | Total |
|---|---|---|---|
| Age, Continuous | 36.9 years STANDARD_DEVIATION 8.9 | 31.9 years STANDARD_DEVIATION 8.6 | 34.8 years STANDARD_DEVIATION 8.6 |
| Sex: Female, Male Female | 7 Participants | 4 Participants | 11 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 11 | 0 / 8 |
| serious Total, serious adverse events | 0 / 11 | 0 / 8 |
Outcome results
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).
Time frame: Baseline and 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Emdogain PLUS | Change in Clinical Attachment Level (CAL) | -2.86 millimeters | Standard Deviation 1.43 |
| Autogenous Bone | Change in Clinical Attachment Level (CAL) | -2.44 millimeters | Standard Deviation 1.08 |
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).
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Emdogain PLUS | Change in Clinical Attachment Level (CAL) | -2.44 mm | Standard Deviation 0.95 |
| Autogenous Bone | Change in Clinical Attachment Level (CAL) | -2.25 mm | Standard Deviation 1.1 |
Secondary
Change in Distance Between the Cementum-enamel-junction and the Base of the Vertical Bone Defect
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Emdogain PLUS | Change in Distance Between the Cementum-enamel-junction and the Base of the Vertical Bone Defect | -2.02 mm | Standard Deviation 1.8 |
| Autogenous Bone | Change in Distance Between the Cementum-enamel-junction and the Base of the Vertical Bone Defect | -2.13 mm | Standard Deviation 1.47 |
Secondary
Change in Distance Between the Cementum-enamel-junction and the Base of the Vertical Bone Defect
Time frame: Baseline and 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Emdogain PLUS | Change in Distance Between the Cementum-enamel-junction and the Base of the Vertical Bone Defect | -2.26 mm | Standard Deviation 1.99 |
| Autogenous Bone | Change in Distance Between the Cementum-enamel-junction and the Base of the Vertical Bone Defect | -2.29 mm | Standard Deviation 1.48 |
Secondary
Change in Probing Pocket Depth (PPD)
PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket.
Time frame: Baseline and 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Emdogain PLUS | Change in Probing Pocket Depth (PPD) | -3.36 millimeters | Standard Deviation 1.42 |
| Autogenous Bone | Change in Probing Pocket Depth (PPD) | -2.75 millimeters | Standard Deviation 1.13 |
Secondary
Change in Probing Pocket Depth (PPD)
PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket.
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Emdogain PLUS | Change in Probing Pocket Depth (PPD) | -2.78 mm | Standard Deviation 1.18 |
| Autogenous Bone | Change in Probing Pocket Depth (PPD) | -2.56 mm | Standard Deviation 1.18 |