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| Name | Class |
|---|---|
| Syneed Medidata GmbH | INDUSTRY |
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This is a controlled, randomized, single-blinded, multicenter, prospective clinical study.
In addition to the standard periodontal treatment procedure on all teeth that need to be treated, the 4 teeth with the deepest pockets (between 4 and 6 mm) will be randomized to either PERIOSYAL® FILL and oral hygiene or oral hygiene alone.
The pocket depth will be measured at six sites around each tooth, and only the deepest pocket sites of each tooth will be taken into account.
This is a controlled, randomized, single-blinded (independent Blinded Evaluator), multicenter, prospective clinical study.
Each subject will receive the standard periodontal treatment procedure on all teeth that need to be treated. The usual cares are scaling and root planing (SRP), and chlorhexidine, and instructions to oral hygiene (proper brushing techniques twice a day, proper flossing technique daily, and prevention : sugar intake, alcohol consumption, fluoride level).
Two other optional treatment sessions with SRP could be performed, if deemed necessary by the Treating Investigator. Those optional SRP session could only be performed after all study-related clinical assessement.
The pocket depth of every teeth will be measured at six sites around each tooth, and only the deepest pocket sites will be taken into account. The 4 teeth with the deepest pockets will be included in the study and randomized to either PERIOSYAL® FILL and oral hygiene or oral hygiene alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PERIOSYAL FILL | Experimental | n=15 |
|
| No treatment (untreated control) | No Intervention | n=15 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PERIOSYAL FILL | Device | Injection 2 weeks after standard periodontal treatment procedure on all teeth that need to be treated. Touch-up treatment provided at 3 and 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pocket Probing Depth (PPD) | PPD is defined as the distance from the gingival margin to the base of the gingival crevice, i.e. the bottom of the clinical pocket. PPD will be measured at six sites per tooth (DV, V, MV, DL, L, ML), using a constant-force computerized periodontal probe with a 0.2 mm precision. Only the deepest will be taken into account | Pre-injection, to 12, 24 and 48 weeks after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pocket Probing Depth (PPD) | Pre-injection, to 2, 5, 8 and 36 weeks after baseline | |
| Change in Clinical Attachment Level (CAL) | CAL is defined as the distance from the Cemento-Enamel Junction (CEJ) to the base of the probable crevice/pocket (the bottom of the clinical pocket) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dental Specialist | Recruiting | Düsseldorf | Germany |
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| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| D010514 | Periodontal Pocket |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D002908 | Chronic Disease |
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| Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline |
| Bleeding On Probing (BOP) | BOP is defined as presence/absence of bleeding within 15 seconds following pocket probing | Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline |
| Tooth Mobility | Tooth Mobility will be assessed on the scale defined by Muehlemann | Pre-injection, to 12, 24, 36 and 48 weeks after baseline |
| Plaque Index (PI) | PI will be measured for each tooth using the four-point scale Silness and Löe Plaque Index | Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline |
| Gingival Index (GI) | GI will be measured for each tooth using the four-point scale Silness and Löe Gingival Index | Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline |
| Oral Health-related quality of life | Oral Health-related quality of life is a patient reported outcome measure specifically pertaining to oral health capturing both the functional, social and psychological impacts of oral disease, assessed using the OHQoL-GE, a validated translation of the OHQoL-UK | Pre-injection, to 12, 24, 36 and 48 weeks after baseline |
| Microbiological analysis of the 11 main periodontal pathogens | Periodontal pathogens will be measured using micro-IDent plus 1/11 Hain tests, a noninvasive saliva prelevement using paper points | : Pre-injection, to 12, 24, 36 and 48 weeks after baseline |
| Physician satisfaction with the treatment | Satisfaction will be assessed on a 5-grade subjective symmetrical scale | 12, 24, 36 and 48 weeks after baseline |
| Subject Satisfaction with the treatment | Satisfaction will be assessed on a 5-grade subjective symmetrical scale | 12, 24, 36 and 48 weeks after baseline |
| Total volume of product injected in each of the included teeth | Volume will be measured to an accuracy of 0.025 mL | during each injection session |
| Pain felt by the patient in the aera (tooth, gum) | Pain will be self-assessed by the subject on each included teeth using a 100 mm Visual Analog Scale (VAS) | Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline |
| Dr. Wahlmann & Partner | Recruiting | Edewecht | Germany |
|
| Universitätsklinikum Hamburg-Eppendorf | Not yet recruiting | Hamburg | Germany |
|
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |