The Effect of Locally Delivered Ciclosporin as an Adjunct to Healing After Treatment of Periodontal Pockets

Phase 2

Completed

• Conditions: Periodontitis
• Interventions: Drug: Ciclosporin

• Registration Number: NCT02366585
• Lead Sponsor: PerioC Limited

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-12
• Study First Submitted QC: 2015-02-12
• Study First Posted: 2015-02-19
• Study Start: 2015-03
• Primary Completion: 2016-09
• Study Completion: 2016-10
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-06
• Last Update Posted: 2017-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with Ciclosporin	Ciclosporin	Treatment of two periodontal pockets with ciclosporin gel Non-treatment of two periodontal pockets in same patient as comparator

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The Sahlgrenska Academy, University of Gothenburg; 🇸🇪 Gothenburg, Sweden