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

NCT02366585 | Completed Phase 2

• 1 other identifier: PERIOC_CTP001
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (2)

• Probing pocket depth (PPD)

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

  3 months

• Bleeding on Probing (BoP)

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

  3 months

Study Arms (1)

Treatment with Ciclosporin

EXPERIMENTAL

Treatment of two periodontal pockets with ciclosporin gel Non-treatment of two periodontal pockets in same patient as comparator

Drug: Ciclosporin

Interventions

Ciclosporin DRUG

Ciclosporin gel applied to two periodontal pockets

Treatment with Ciclosporin

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients in good general health
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PerioC Limited: lead

Study Sites (1)

The Sahlgrenska Academy, University of Gothenburg

Gothenburg, 40530, Sweden

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Cyclosporine

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Per Ramberg, PhD

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2015
• First Posted: February 19, 2015
• Study Start: March 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: April 7, 2017

Record last verified: 2017-04

Locations

SE (1)