The Effect of Locally Delivered Ciclosporin as an Adjunct to Healing After Treatment of Periodontal Pockets

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of the trial is to investigate the effect of locally delivered ciclosporin as an adjunct to non-surgical mechanical debridement in the treatment of chronic periodontitis and to compare it to mechanical debridement alone.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PerioC Limited
• Treatments: Cyclosporine; Cyclosporins

Criteria

Inclusion Criteria:

• Patients in good general health

• 2 pairs of contralateral interproximal periodontal sites with probing depths of ≥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.

• Teeth selected should have a vital pulp as determined by thermal or electric stimulation

Exclusion Criteria:

• Patients already included in other clinical trials involving therapeutic intervention (either medical or dental)

• Periodontal treatment during the last 6 months

• Antibiotic treatment 6 months prior to the start of the trial

• Antibiotic prophylaxis required for dental treatment

• Patients with acute infectious lesions in the areas of intended treatment

• Regular anti-inflammatory medication

• Known history of ciclosporin allergy

• Ongoing medication that may affect the clinical features of periodontitis

• Patients who are smokers

• Patients that are immuno-compromized or on immunosuppressive medication

• Patients who are pregnant or lactating