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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02366585
• Other study ID #: PERIOC_CTP001
• Status: Completed
• Phase: Phase 2
• First received: February 12, 2015
• Last updated: April 6, 2017
• Start date: March 2015
• Est. completion date: October 2016

Study information

• Verified date: April 2017
• Source: PerioC Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Pocket
• Periodontitis

Intervention

Drug:
• Ciclosporin
Ciclosporin gel applied to two periodontal pockets

Locations

Country	Name	City	State
Sweden	The Sahlgrenska Academy, University of Gothenburg	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
PerioC Limited

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing pocket depth (PPD)	Mean change in probing pocket depth (PPD) from baseline to 3-month examination	3 months
Primary	Bleeding on Probing (BoP)	Change in BoP (measured as present or absent) from baseline to 3-month examination	3 months