Overview

This trial is active, not recruiting.

Condition periodontitis
Treatment ciclosporin
Phase phase 2
Sponsor PerioC Limited
Start date March 2015
End date August 2016
Trial size 23 participants
Trial identifier NCT02366585, PERIOC_CTP001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Treatment of two periodontal pockets with ciclosporin gel Non-treatment of two periodontal pockets in same patient as comparator
ciclosporin
Ciclosporin gel applied to two periodontal pockets

Primary Outcomes

Measure
Probing pocket depth (PPD)
time frame: 3 months
Bleeding on Probing (BoP)
time frame: 3 months

Eligibility Criteria

Male or female participants at least 30 years old.

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

Additional Information

Official title The Effect of Locally Delivered Ciclosporin as an Adjunct to Healing After Treatment of Periodontal Pockets
Principal investigator Per Ramberg, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by PerioC Limited.