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

NCT ID: NCT02366585

Last Updated: 2017-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Periodontitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment with Ciclosporin

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

Group Type EXPERIMENTAL

Ciclosporin

Intervention Type DRUG

Ciclosporin gel applied to two periodontal pockets

Interventions

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Ciclosporin

Ciclosporin gel applied to two periodontal pockets

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PerioC Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Per Ramberg, PhD

Role: PRINCIPAL_INVESTIGATOR

Göteborg University

Locations

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The Sahlgrenska Academy, University of Gothenburg

Gothenburg, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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PERIOC_CTP001

Identifier Type: -

Identifier Source: org_study_id

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