Back to resultsThe Effect of Locally Delivered Ciclosporin as an Adjunct to Healing After Treatment of Periodontal Pockets
Primary Purpose
Periodontitis
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Ciclosporin
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis
Eligibility Criteria
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
Sites / Locations
- The Sahlgrenska Academy, University of Gothenburg
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment with Ciclosporin
Arm Description
Treatment of two periodontal pockets with ciclosporin gel Non-treatment of two periodontal pockets in same patient as comparator
Outcomes
Primary Outcome Measures
Probing pocket depth (PPD)
Mean change in probing pocket depth (PPD) from baseline to 3-month examination
Bleeding on Probing (BoP)
Change in BoP (measured as present or absent) from baseline to 3-month examination
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02366585
Brief Title
The Effect of Locally Delivered Ciclosporin as an Adjunct to Healing After Treatment of Periodontal Pockets
Official Title
The Effect of Locally Delivered Ciclosporin as an Adjunct to Healing After Treatment of Periodontal Pockets
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PerioC Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment with Ciclosporin
Arm Type
Experimental
Arm Description
Treatment of two periodontal pockets with ciclosporin gel Non-treatment of two periodontal pockets in same patient as comparator
Intervention Type
Drug
Intervention Name(s)
Ciclosporin
Intervention Description
Ciclosporin gel applied to two periodontal pockets
Primary Outcome Measure Information:
Title
Probing pocket depth (PPD)
Description
Mean change in probing pocket depth (PPD) from baseline to 3-month examination
Time Frame
3 months
Title
Bleeding on Probing (BoP)
Description
Change in BoP (measured as present or absent) from baseline to 3-month examination
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Ramberg, PhD
Organizational Affiliation
Göteborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Sahlgrenska Academy, University of Gothenburg
City
Gothenburg
ZIP/Postal Code
40530
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
The Effect of Locally Delivered Ciclosporin as an Adjunct to Healing After Treatment of Periodontal Pockets
We'll reach out to this number within 24 hrs