Status:
COMPLETED
Photodynamic Therapy Plus Root Debridement in Gum Disease Treatment V2
Lead Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborating Sponsors:
Ondine Biomedical Inc.
Conditions:
Periodontitis
Eligibility:
All Genders
30+ years
Phase:
NA
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 bet...
Detailed Description
The study will be a single centre, examiner masked, two arm, split mouth, randomized controlled clinical trial, to evaluate the clinical effectiveness of mechanical cleaning (RSD) plus additional use ...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
October 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2018
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03270254
Start Date
October 13 2017
End Date
September 19 2018
Last Update
May 30 2019
Active Locations (1)
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1
Sheffield Teaching Hospitals NHS Trust
Sheffield, South Yorkshire, United Kingdom, S10 2JF