Photodynamic Therapy Plus Root Debridement in Gum Disease Treatment V2 (PDTV2)
Primary Purpose
Periodontitis
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
light activated dye photodynamic therapy (PDT)
Sponsored by

About this trial
This is an interventional treatment trial for Periodontitis
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Sheffield Teaching Hospitals NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
root surface debridement (RSD)
light activated dye (PDT)
Arm Description
Standard care - root surface debridement (RSD)
light activated dye photodynamic therapy (PDT)
Outcomes
Primary Outcome Measures
Pocket depth change
The difference in mean change of probing pocket depth in millimetres between the test and control sites
Secondary Outcome Measures
Change in clinical attachment
The difference in mean change of clinical attachment loss in millimetres between the test and control sites.
Bleeding on probing
The percentage difference of bleeding on probing between tests and controls.
Probing depths originally ≥ 6mm.
The percentage difference of sites with probing depths originally ≥ 6mm.
Probing depths originally ≤3mm
The percentage increase of sites with probing depths originally ≤3mm
Number of sites improving by ≥2mm
The total number of sites improving by ≥2mm
Percentage of sites improving by ≥2mm
The percentage of sites improving by ≥2mm
Full Information
NCT ID
NCT03270254
First Posted
August 30, 2017
Last Updated
May 28, 2019
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
Ondine Biomedical Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03270254
Brief Title
Photodynamic Therapy Plus Root Debridement in Gum Disease Treatment V2
Acronym
PDTV2
Official Title
A Split-mouth Randomised Controlled Clinical Trial of Photodynamic Therapy (PDT) as Adjunctive Therapy to Root Surface Debridement (RSD), Compared to RSD Alone in the Treatment of Residual Periodontal Pockets in Patients With Chronic Periodontitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 13, 2017 (Actual)
Primary Completion Date
September 19, 2018 (Actual)
Study Completion Date
September 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
Ondine Biomedical Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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 of a light activated dye (photodynamic therapy-PDT) compared to mechanical cleaning alone, in the treatment of residual pockets, in patients with chronic gum disease. The null hypothesis is that there is no difference between RSD and the additional use of PDT compared to RSD alone, when treating patients with chronic gum disease. The local delivery treatment of PDT requires the low power light to be shone into the pocket for 1 minute in order to activate the dye which kills the bacteria. For this reason it is a treatment which is more suited to treating localised rather than widespread disease. Thus, patients with chronic gum problems who have had a cycle of treatment with the hygienist, but have a few residual pockets will be selected for this study. Subjects will be recruited from patients attending the hygienist following a first cycle of RSD, who have sufficient remaining disease to represent a meaningful challenge. This reflects the normal care pathway for patients, where simple approaches to treatment are followed up with more complicated therapy for any areas which fail to respond. A power calculation has shown that 29 patients are expected to be enough to see if PDT & RSD can produce better gum health than RSD alone. However, to account for unexpected patient withdrawals, 35 patients will be recruited to this study. The staff hygienists in the department are capable of providing treatment for 60-90 patients over a 3-month period. Out of these patients those with more severe disease are likely to have residual pockets that require further cycles of RSD. Thus there is potentially a good population of patients attending Charles Clifford Dental Hospital to recruit from. All residual sites within a subject who participates in the study will be treated by mechanical cleaning. This is the standard treatment which would apply for most patients in this situation. A random allocation procedure will be used to designate sections of the mouth to receive additional treatment with the PDT. This will not be made known to the operator performing the RSD until after they have completed that aspect of treatment. This helps reduce bias as the operator will clean all sites to an equivalent standard. The split mouth approach means that the patient will act as their own control. This helps reduce the numbers of patients which need to be recruited as compared to a study with 2 parallel groups, where each group receives a different treatment. The suggested disadvantage of a split mouth design, is the fact that there may be some contamination of RSD sites only with the action of a chemical remote from the site it was originally placed in. However, in this study the chemical needs to be activated by the light, and therefore it is easier to control the activity of PDT therapy to the sites it was designated to be used in. For this reason there needs to be a gap between the section of the mouth treated by adjunctive PDT & RSD, compared to the section of the mouth where RSD alone is the treatment. No additional appointments will be required of the patients compared to the normal protocol as they will receive the "gold standard" treatment of mechanical cleaning (RSD) in all sites. The additional requirements of the study will be the time it takes to provide treatment using PDT. This is anticipated to be between 5-15 minutes depending upon the number and distribution of sites throughout the mouth. Sample collection of bacterial plaque and gum fluid from 2 sites per patient will take an additional 5-10 minutes. The normal treatment time at this stage of treatment would be 60 minutes and this will be extended to 70-85 minutes for the study purposes. None of the additional procedures are likely to cause discomfort. The 3 month re-assessment examination will require repeat sample collection of bacterial plaque and gum fluid from 2 sites which will take an additional 5-10 minutes. Thus the standard patient reassessment appointment of 60 minutes will be extended to 65-70 minutes. The full process from recruitment of patients to writing up this student project is expected to be finished within seven to nine months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Randomised Split mouth
Masking
Outcomes Assessor
Masking Description
The patient and Dentist will both be aware of the type of treatment, The researcher analysing the collected samples will be blind to treatment
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
root surface debridement (RSD)
Arm Type
No Intervention
Arm Description
Standard care - root surface debridement (RSD)
Arm Title
light activated dye (PDT)
Arm Type
Active Comparator
Arm Description
light activated dye photodynamic therapy (PDT)
Intervention Type
Device
Intervention Name(s)
light activated dye photodynamic therapy (PDT)
Intervention Description
light activated dye photodynamic therapy-PDT to periodontal pockets
Primary Outcome Measure Information:
Title
Pocket depth change
Description
The difference in mean change of probing pocket depth in millimetres between the test and control sites
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in clinical attachment
Description
The difference in mean change of clinical attachment loss in millimetres between the test and control sites.
Time Frame
3 months
Title
Bleeding on probing
Description
The percentage difference of bleeding on probing between tests and controls.
Time Frame
3 months
Title
Probing depths originally ≥ 6mm.
Description
The percentage difference of sites with probing depths originally ≥ 6mm.
Time Frame
3 months
Title
Probing depths originally ≤3mm
Description
The percentage increase of sites with probing depths originally ≤3mm
Time Frame
3 months
Title
Number of sites improving by ≥2mm
Description
The total number of sites improving by ≥2mm
Time Frame
3 months
Title
Percentage of sites improving by ≥2mm
Description
The percentage of sites improving by ≥2mm
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gareth Griffiths
Organizational Affiliation
University of Sheffield
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheffield Teaching Hospitals NHS Trust
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2JF
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
The research findings will probably be published in a scientific journal
Learn more about this trial
Photodynamic Therapy Plus Root Debridement in Gum Disease Treatment V2
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