PeriodontitisPhase 2NCT02366585
The Effect of Locally Delivered Ciclosporin as an Adjunct to Healing After Treatment of Periodontal Pockets
A Phase 2 study testing Ciclosporin in people with Periodontitis, run by PerioC Limited at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Periodontitis
- What is being tested?
- Ciclosporin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2015to Oct 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
The Sahlgrenska Academy, University of Gothenburg
Gothenburg, 40530
About this study
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.
- Conditions
- Periodontitis
- Being tested
- Ciclosporin
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiclosporinDrug
Ciclosporin gel applied to two periodontal pockets
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Ciclosporin | Experimental | Treatment of two periodontal pockets with ciclosporin gel Non-treatment of two periodontal pockets in same patient as comparator Receives: Drug: Ciclosporin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket depth (PPD)
Mean change in probing pocket depth (PPD) from baseline to 3-month examination
Measured: 3 months
Bleeding on Probing (BoP)
Change in BoP (measured as present or absent) from baseline to 3-month examination
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionSep 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- PerioC Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Per Ramberg, PhD, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366585
- Sponsor's protocol ID
- PERIOC_CTP001
- Status last verified
- Apr 2017
- First submitted
- 12 Feb 2015
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Locally Delivered Ciclosporin as an Adjunct to Healing After Treatment of Periodontal Pockets
- ClinicalTrials.gov ID
- NCT02366585
- Acronym / sponsor ID
- PERIOC_CTP001
- Conditions
- Periodontitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- PerioC LimitedIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 19 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with Ciclosporin | Experimental | Drug: CiclosporinTreatment of two periodontal pockets with ciclosporin gel Non-treatment of two periodontal pockets in same patient as comparator |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CiclosporinCiclosporin gel applied to two periodontal pockets | Drug | Treatment with Ciclosporin |
Primary outcome
Probing pocket depth (PPD)
Time frame: 3 months
Mean change in probing pocket depth (PPD) from baseline to 3-month examination
Bleeding on Probing (BoP)
Time frame: 3 months
Change in BoP (measured as present or absent) from baseline to 3-month examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Ramberg, PhD principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ciclosporin in people with Periodontitis, run by PerioC Limited at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing pocket depth (PPD) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.