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Photodynamic Therapy Plus Root Debridement in Gum Disease Treatment V2

NCT03270254 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2019-05-30

No results posted yet for this study

Summary

Gum disease is a common disease, which affects 45% of the UK adult dentate population. It is caused by bacteria in dental plaque, which produces inflammation and a deepening of the natural crevice between the gum and the tooth surface. A crevice of 3mm is considered to be within the normal range, but anything ≥4mm is considered to be abnormal and is called a "pocket". Standard treatment of gum disease is mechanical cleaning aimed at removing bacteria off the root surfaces of the teeth. For most teeth, in the majority of patients, this can be achieved by root surface debridement (RSD), which involves passing instruments into the gum pockets to clean the roots. Previous studies have shown that the outcome of treatment is less effective when the pockets are deeper, or where there is bone or root anatomy which makes access for RSD difficult. In such instances additional approaches, such as repeating RSD, surgical access, or the additional use of antibiotics are considered. This clinical study will investigate the benefits and drawbacks of using a light source and dye (photodynamic therapy - PDT) as an additional treatment compared to the standard treatment of RSD alone. Patients with chronic gum problems who have undergone 1 cycle of RSD, but have residual pockets will be invited to join the study. All residual pockets will be treated with the conventional treatment of RSD. Following a random allocation process the residual pockets in half the mouth will receive additional treatment with PDT at the same appointment. Patients will be followed up for 3 months to evaluate the clinical benefits and any side effects. The aim of the study is therefore to evaluate if this localised, simple treatment can add benefit to RSD alone, thus reducing the need for antibiotics or surgery to treat residual pockets.

Conditions

  • Periodontitis

Interventions

DEVICE

light activated dye photodynamic therapy (PDT)

light activated dye photodynamic therapy-PDT to periodontal pockets

Sponsors & Collaborators

  • Ondine Biomedical Inc.

    collaborator INDUSTRY

  • Sheffield Teaching Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Gareth Griffiths · University of Sheffield

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-13
Primary Completion
2018-09-19
Completion
2018-09-19

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03270254 on ClinicalTrials.gov