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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
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.
Dental Specialist
Düsseldorf, Germany
RECRUITINGDr. Wahlmann & Partner
Edewecht, Germany
RECRUITINGUniversitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
NOT_YET_RECRUITINGChange 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
Time frame: Pre-injection, to 12, 24 and 48 weeks after baseline
Change in Pocket Probing Depth (PPD)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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Time frame: 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
Time frame: 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
Time frame: : 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
Time frame: 12, 24, 36 and 48 weeks after baseline
Subject Satisfaction with the treatment
Satisfaction will be assessed on a 5-grade subjective symmetrical scale
Time frame: 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
Time frame: 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)
Time frame: Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline