The Effect of Locally Delivered Ciclosporin as an Adjunct to Healing After Treatment of Periodontal Pockets
This trial is active, not recruiting.
|Start date||March 2015|
|End date||August 2016|
|Trial size||23 participants|
|Trial identifier||NCT02366585, PERIOC_CTP001|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Treatment of two periodontal pockets with ciclosporin gel Non-treatment of two periodontal pockets in same patient as comparator
Probing pocket depth (PPD)
time frame: 3 months
Bleeding on Probing (BoP)
time frame: 3 months
Male or female participants at least 30 years old.
- 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
- 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
|Official title||The Effect of Locally Delivered Ciclosporin as an Adjunct to Healing After Treatment of Periodontal Pockets|
|Principal investigator||Per Ramberg, PhD|
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