CHRONIC PERIODONTITIS MedDRA version: 8.1 Level: LLT Classification code 10009102 Term: Chronic periodontitis
Conditions
Interventions
Pharmaceutical Form: Capsule*
Current Sponsor code: unsaponifiable fraction of avocado oil
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 33-
Current
Sponsors
Laboratoires Expanscience
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Female and male patients, aged 40 to 70 years, suffering from chronic periodontitis with at least 6 teeth bearing a periodontal pocket = 5 mm which bleeds on probing, with at least 13 natural teeth, nonsmokers or having quit smoking for more than a year. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients presenting with the following problems will not be included into the study: aggressive periodontitis, severe immune depression or auto-immune disorder, active or past acute or chronic severe condition of the cardiovascular system, kidneys, liver, gastro-intestinal tract, endocrine system, hematologic system, nervous system, or allergy, judged by the investigator as incompatible with the trial, coagulopathy or anticoagulant treatment, concomitant addiction interfering with the disease, hypersensitivity to Piascledine® or one of its ingredients, antibiotic treatment during the past month, nonsteroidal or steroidal anti-inflammatory treatment during the past month, or periodontal surgical treatment during the previous three months. Female patients will not be included if they are pregnant, are breast feeding, or are not making use of effective contraception. Patients will not be included if they have undergone scaling and root planing in the previous three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary evaluation criterion will be gingival inflammation index, evaluated as the difference between baseline and the last available assessment. Covariance analysis will be carried out on the difference, using the index at baseline as covariant, and treatment as factor. Analysis of efficacy will be done on ITT and per protocol (PP) populations. ;Main Objective: The primary criterion is the evolution of the gingival inflammation index, which will be assessed at visits D1 (inclusion), M3, M6, and M9, on natural teeth.;Secondary Objective: 1- Assessment of papillary bleeding index 2- Depth of periodontal pocket and gum recession 3- Plaque index 4- Assessment of various inflammation markers in gingival fluid (IL-1ß, MMP-1, MMP-8, TIMP-1, TNFa, TGFß) 5- Quantification of pathogens 6- Patient and investigator's overall assessment of treatment efficacy and tolerance on a 4-point qualitative scale. The primary criterion and secondary criteria 1 through 4 will be evaluated on the patient's natural teeth. For every selected teeth, the following 6 periodontal localizations will be measured: mesiolabial, labial, distolabial, mesiolingual (or mesiopalatine), lingual (or palatine), distolingual (or distopalatine). Secondary criteria 5 & 6 will be evaluated at inclusion and upon treatment completion, on 6 sites corresponding to the 6 teeth for which the pocket depth is greatest (= 5mm). | — |
Countries
Belgium
Outcome results
None listed