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

P

PerioC

Status and phase

Completed
Phase 2

Conditions

Periodontitis

Treatments

Drug: Ciclosporin

Study type

Interventional

Funder types

Industry

Identifiers

NCT02366585
PERIOC_CTP001

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

23 participants in 1 patient group

Treatment with Ciclosporin
Experimental group
Description:
Treatment of two periodontal pockets with ciclosporin gel Non-treatment of two periodontal pockets in same patient as comparator
Treatment:
Drug: Ciclosporin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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