Periodontitis
Conditions
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.
Interventions
DRUGCiclosporin
Ciclosporin gel applied to two periodontal pockets
Sponsors
PerioC Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probing pocket depth (PPD) | 3 months | Mean change in probing pocket depth (PPD) from baseline to 3-month examination |
| Bleeding on Probing (BoP) | 3 months | Change in BoP (measured as present or absent) from baseline to 3-month examination |
Countries
Sweden
Outcome results
None listed