Moderate to severe chronic periodontitis
Conditions
Interventions
Product Name: Ciclosporin Nanosuspension Gel
Pharmaceutical Form: Periodontal gel
INN or Proposed INN: CICLOSPORIN
CAS Number: 59865-13-3
Concentration unit: mg/ml milligram(s)/millilitre
Concentratio
Sponsors
PerioC Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Provision of informed consent 2) Patients must be at least 40 years of age and in good general health according to medical history and clinical judgment. 3) Patients must have 2 pairs of contralateral interproximal periodontal sites with probing depths of at least 7mm in single-rooted teeth, not associated with furcations or root furrows. The test sites should have a distance of at least two teeth to the control sites. 4) Teeth selected should have a vital pulp as determined by thermal or electric stimulation. 5) Available for appointments and willingness to strictly adhere to re- examination schedule 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1) Patients already included in other clinical trials involving therapeutic intervention (either medical or dental). 2) Periodontal treatment during the last 6 months. 3) Antibiotic treatment 6 months prior to the start of the trial. 4) Antibiotic prophylaxis required for dental treatment. 5) Patients with acute infectious lesions in the areas of intended treatment. 6) Regular anti-inflammatory medication. 7) Known history of ciclosporin allergy. 8) Ongoing medication that may affect the clinical features of periodontitis. (e.g., antibiotics or immuno-modulatory/ immunosuppressive drugs such as dexamethasone, prednisone, tacrolimus) 9) Patients who are smokers. 10) Patients that are immuno-compromised or on immunosuppressive medication. 11) Patients who are pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the effectiveness of a mucoadhesive thermosensitive formulation of ciclosporin, administered into gingival pockets of patients with chronic periodontal disease to reduce the inflammation and promote reattachment and healing, measured by probing pocket depth and frequency of bleeding on probing. ;Secondary Objective: The secondary objectives selected for this study are to assess the local anti-inflammatory effectiveness of the drug by measuring inflammatory biomarkers in gingival crevicular fluid, to assess progress of healing by measuring gains in clinical attachment level, and to assess the safety of the drug for this indication.;Primary end point(s): The primary endpoints selected are: 1) Mean change in probing pocket depth from baseline to 3-month examination. 2) Change in bleeding on probing (measured as present or absent) from baseline to 3-month examination.;Timepoint(s) of evaluation of this end point: 1) Baseline and 3-month examination 2) Baseline and 3-month examination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints selected are: 1) Frequency of periodontal pockets showing a probing pocket depth = 4 mm and with no bleeding on probing at the 3-month examination. 2) Changes in biomarker (tumour necrosis factor-a, matrix metalloproteinase-8, matrix metalloproteinase-13, prostaglandin E2 and cyclophilin A) concentrations: Baseline versus 3-day, 10-day and 3-month examination. 3) Gain in clinical attachment level (CAL) in mm at 3-months examination time point relative to baseline. 4) Safety evaluation (adverse events). ;Timepoint(s) of evaluation of this end point: 1) 3-month examination 2) Baseline, 3-day, 10-day and 3-month examination 3) Baseline and 3-month examination 4) 3-day, 7-day, 10-day and 3-month examination | — |
Countries
Sweden
Contacts
Public ContactBettina Barton
SFL Regulatory Affairs & Scientific Communication Ltd
Outcome results
None listed