KLOX PERIO-1 Gel as adjunct to routine scaling in periodontal patients
Research type
Research Study
Full title
Clinical evaluation of KLOX PERIO-1 Gel (CE marked Medical Device) to be used as an adjunct therapy to the standard to routine scaling(S) in patients with moderate to severe periodontal disease.
IRAS ID
199166
Contact name
Philip Preshaw
Contact email
Sponsor organisation
Colgate-Palmolive Europe sàrl
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
This is a multicentre, an examiner blinded, split mouth, randomized controlled phase IV clinical trial. The aim of the trial is to assess the effectiveness and safety of KLOX Perio-1 Gel (CE marked Medical Device) to be used as an adjunct therapy to standard routine scaling (S) in patients with moderate to severe periodontal disease. The effects of KLOX Perio-1 Gel will be determined by measuring the change in clinical attachment level at 6 months.
The study is sponsored by Colgate Palmolive Europe sàrl. Sixty patients will be included across 2 countries. In UK, two sites are involved: Dr Philip Preshaw in Newcastle Upon Tyne, and Dr Mark Ide, in King’s College, London and 1 site in Italy. The study duration is 7 months, each participant patient will attend for 5 visits. Patients will be given an explanation of the study at a scheduled clinic visit, and then asked to sign a consent form if they agree to participate.
The patient will be treated at visit 2 after randomisation. The study will be performed under examiner blind conditions. Clinicians will follow up the patient involved in study. One clinician will perform the scaling and gel treatment and another clinician will be responsible for all clinical assessments to ensure the blinding throughout the entire study. All clinicians involved in the trial are qualified and trained on the research procedure before study start.
Two sextants from patient’s mouth will be selected for being treated. One sextant will receive the gel (test sextant) and the other one (control sextant) will receive only scaling at visit 2 using ultrasonic and hand instruments as required. For the test sextant, the clinician will apply the gel twice (pre- and post-scaling) using a in-office LED curing lamp which activates KLOX PERIO-1 Gel by illumination at a distance of approximatively 3 to 5 mm from gingival surface during 10 seconds maximum per treated tooth.
The safety and tolerability will be assessed throughout the study
The primary objective for statistical analysis is to compare the change in clinical attachment level (CAL) after six months of treatment.
The study results will be published in a scientific review and congress.REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
16/LO/1259
Date of REC Opinion
9 Aug 2016
REC opinion
Further Information Favourable Opinion