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OpenTrials
Completed

NCT Number: NCT02366585

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

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Sahlgrenska Academy, University of Gothenburg

Gothenburg, 40530, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ciclosporin

Drug

Ciclosporin gel applied to two periodontal pockets

Primary outcomes

  1. Probing pocket depth (PPD)

    Time frame: 3 months

    Mean change in probing pocket depth (PPD) from baseline to 3-month examination

  2. Bleeding on Probing (BoP)

    Time frame: 3 months

    Change in BoP (measured as present or absent) from baseline to 3-month examination

Sponsors and collaborators

Lead sponsor

PerioC Limited

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 19, 2015
Registry last updated
Apr 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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