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

April 6, 2017 updated by: PerioC Limited
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden, 40530
        • The Sahlgrenska Academy, University of Gothenburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment with Ciclosporin
Treatment of two periodontal pockets with ciclosporin gel Non-treatment of two periodontal pockets in same patient as comparator
Drug: Ciclosporin
Ciclosporin gel applied to two periodontal pockets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing pocket depth (PPD)
Time Frame: 3 months
Mean change in probing pocket depth (PPD) from baseline to 3-month examination
3 months
Bleeding on Probing (BoP)
Time Frame: 3 months
Change in BoP (measured as present or absent) from baseline to 3-month examination
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PerioC Limited

Investigators

  • Principal Investigator: Per Ramberg, PhD, Göteborg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

February 12, 2015

First Submitted That Met QC Criteria

February 12, 2015

First Posted (Estimate)

February 19, 2015

Study Record Updates

Last Update Posted (Actual)

April 7, 2017

Last Update Submitted That Met QC Criteria

April 6, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PERIOC_CTP001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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