Official Title
The Effect of Locally Delivered Ciclosporin as an Adjunct to Healing After Treatment of Periodontal Pockets
Phase
Phase 2Lead Sponsor
PerioC LimitedStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
PeriodontitisIntervention/Treatment
cyclosporine ...Study Participants
23The 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.
Ciclosporin gel applied to two periodontal pockets
Treatment of two periodontal pockets with ciclosporin gel Non-treatment of two periodontal pockets in same patient as comparator
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