NCT02366585
Completed
Phase 2
The Effect of Locally Delivered Ciclosporin as an Adjunct to Healing After Treatment of Periodontal Pockets
PerioC Limited1 site in 1 country23 target enrollmentMarch 2015
Overview
- Phase
- Phase 2
- Intervention
- Ciclosporin
- Conditions
- Periodontitis
- Sponsor
- PerioC Limited
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Probing pocket depth (PPD)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
Eligibility 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
Arms & Interventions
Treatment with Ciclosporin
Treatment of two periodontal pockets with ciclosporin gel Non-treatment of two periodontal pockets in same patient as comparator
Intervention: Ciclosporin
Outcomes
Primary Outcomes
Probing pocket depth (PPD)
Time Frame: 3 months
Mean change in probing pocket depth (PPD) from baseline to 3-month examination
Bleeding on Probing (BoP)
Time Frame: 3 months
Change in BoP (measured as present or absent) from baseline to 3-month examination
Study Sites (1)
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