A trial looking at how well locally applied ciclosporin can support the healing after non-surgical treatment of chronic periodontitis

Conditions: Moderate to severe chronic periodontitis
Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]

Registration Number: EUCTR2014-002625-35-SE

Lead Sponsor: PerioC Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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.