Photodynamic Therapy Plus Root Debridement in Gum Disease Treatment V2

NCT03270254 | Completed

• 1 other identifier: STH19404
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Pocket depth change

  The difference in mean change of probing pocket depth in millimetres between the test and control sites

  3 months

Secondary Outcomes (6)

• Change in clinical attachment

  3 months

• Bleeding on probing

  3 months

• Probing depths originally ≥ 6mm.

  3 months

• Probing depths originally ≤3mm

  3 months

• Number of sites improving by ≥2mm

  3 months

Study Arms (2)

root surface debridement (RSD)

NO INTERVENTION

Standard care - root surface debridement (RSD)

light activated dye (PDT)

ACTIVE COMPARATOR

light activated dye photodynamic therapy (PDT)

Device: light activated dye photodynamic therapy (PDT)

Interventions

light activated dye photodynamic therapy (PDT) DEVICE

light activated dye photodynamic therapy-PDT to periodontal pockets

light activated dye (PDT)

Eligibility Criteria

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

You may qualify if:

• Adult patients ≥ 30 years old
• Presence of at least 20 remaining teeth
• Patients diagnosed with moderate to severe chronic periodontitis, according to Armitage 1999 classification
• Have undergone a minimum of one cycle of full mouth nonsurgical root surface debridement.
• A minimum of 8 residual periodontal pockets (≥4mm) per patient and a maximum of 24. Amongst these, at least one site per half mouth must exhibit pocket depths of ≥ 6 mm.
• Pockets distribution should allow for split mouth design using sextants in a diagonal orientation.
• Received no active periodontal treatment for the last three months.
• Full mouth plaque score and full mouth bleeding score ≤ 30%.
• Sites in the other half of the mouth to be separated by one or more teeth (avoids photosensitising agent affecting the other half).

You may not qualify if:

• Patients with systemic diseases that may alter the response to treatment and healing in periodontal diseases.
• Pregnancy and lactation.
• The use of systemic or local antibiotic in the past three months.
• The need for antibiotic prophylaxis before periodontal treatment.
• Use of antimicrobial mouth rinses in the preceding two months.
• The use of any pharmacological agents that could influence the study outcome or inflammatory indicators (e.g. patients currently on photosensitizing medications).
• Confirmed or suspected allergy or hypersensitivity to methylene blue.
• Confirmed or suspected allergy or hypersensitivity to chlorhexidine.
• Confirmed or suspected allergy or hypersensitivity to polymethyl methacrylate (PMMA).
• Patients with severe glucose-6-phosphate dehydrogenase (G6PD) deficiency.
• Inability to perform proper oral hygiene due to physical impairment.
• Patients unable to consent for themselves.

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• Ondine Biomedical Inc.: collaborator

Study Sites (1)

Sheffield Teaching Hospitals NHS Trust

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Gareth Griffiths

  University of Sheffield

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The patient and Dentist will both be aware of the type of treatment, The researcher analysing the collected samples will be blind to treatment
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised Split mouth

Study Record Dates

• First Submitted: August 30, 2017
• First Posted: September 1, 2017
• Study Start: October 13, 2017
• Primary Completion: September 19, 2018
• Study Completion: September 19, 2018
• Last Updated: May 30, 2019

Record last verified: 2019-05

Locations

GB (1)