The effect of locally delivered ciclosporin as an adjunct to healing after treatment of periodontal pockets

PerioC Ltd0 sitesNovember 6, 2014

Overview

No summary available.

Registry

who.int

Start Date

November 6, 2014

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

PerioC Ltd

•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

•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.