Treatment of Periodontitis with a Photoactivated Disinfection System
| ISRCTN | ISRCTN15434154 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15434154 |
| Secondary identifying numbers | EK Nr: 1860/2014 |
- Submission date
- 24/07/2018
- Registration date
- 02/08/2018
- Last edited
- 01/08/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Chronic periodontitis is a disease which attacks the tissues surrounding the teeth and has a very high prevalence in adults. As periodontitis progresses, the bones and teeth can be damaged, which can lead to tooth loss if left untreated. Any periodontal pockets that have formed require deep cleaning called scaling and root planing in order to enable healing. In some severe cases, the deep cleaning is combined with other treatment options in able to improve the therapy outcome. Photoactivated disinfection is a treatment method that is associated with the use of a light source and a photosensitizer to disinfect the area and clear bacteria. The aim of this study is to investigate photoactivated disinfection as a complementary treatment to conventional periodontal treatment such as deep cleaning.
Who can participate?
Adults aged over 35 with periodontitis
What does the study involve?
All participants will receive the same treatment - standard periodontal treatment (deep cleaning) on both sides of the mouth. Each participant will have one side of their mouth randomly allocated to receive photoactivated disinfection.
What are the possible benefits and risks of participating?
The possible benefit of participating is that photoactivated disinfection may improve the success of regular gum treatment. The possible risk is that the dye used in the treatment may result in transient staining of the oral mucosa.
Where is the study run from?
University Clinical of Dentistry, Medical University of Vienna, Austria
When is the study starting and how long is it expected to run for?
October 2014 to June 2016
Who is funding the study?
Medical University of Vienna (Austria)
Who is the main contact?
1. Professor Rausch-Fan, xiaohui.rausch-fan@meduniwien.ac.at
2. Dr Selma Husejnagic, selma.husejnagic@meduniwien.ac.at
Contact information
Scientific
Sensengasse 2 A
Vienna
1090
Austria
 ORCID ID |
0000-0001-8727-8205 |
|---|
Study information
| Study design | Interventional single-centre randomised split-mouth randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Photoactivated Disinfection with a Light-Emitting Diode in Periodontal Treatment – a Randomized Controlled Clinical Split-mouth Trial |
| Study acronym | PADLED |
| Study objectives | Adjunctive Photoactivated Disinfection with a red LED has an additional beneficial effect in treatment of chronic periodontitis. |
| Ethics approval(s) | Ethikommission Medizinische Universität Wien, 13/02/2015, 1860/2014 |
| Health condition(s) or problem(s) studied | Chronic periodontitis |
| Intervention | Participants were randomised into a split-mouth design, with allocation of the side to be treated (left or right) performed by drawing lots before the initial periodontal examination. Clinical and microbiological parameters were evaluated in the initial examination. Subsequently, supra and subgingival debridement was performed using ultrasonic instruments, universal curettes and Gracey curettes. One side of each study participant’s upper and lower jaws was treated with photoactivated disinfection during the two final cleaning sessions. The contralateral side remained untreated and served as a control. Adjuvant treatment was carried out at six locations around all teeth (mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual), and protective eyewear was provided to all participants. The photosensitizer, a 0.01% tolonium chloride solution, was applied to the pocket and after 60 seconds the area was irradiated with light for 60 seconds per location according to the manufacturer. The pockets were than irrigated with physiological saline solution. Clinical and microbiological parameters were repeated 12 weeks after initial treatment. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Bleeding on probing, assessed during probing with a calibrated standard probe at the initial examination (baseline) and 12 weeks after the last treatment (re-evaluation) |
| Secondary outcome measures | 1. Oral hygiene, assessed using The Approximal-Plaque-Index (API) and the Papillary Bleeding Index (PBI) at the initial examination (baseline), at debridement and 12 weeks after the last treatment (re-evaluation) 2. Clinical attachment level, measured to the nearest millimeter using a calibrated standard probe at baseline and re-evaluation 3. Periodontal pocket depth, measured to the nearest millimeter using a calibrated standard probe at baseline and re-evaluation |
| Overall study start date | 01/10/2014 |
| Completion date | 30/06/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 20 |
| Key inclusion criteria | 1. Presence of moderate to severe periodontitis 2. Aged 35 years or older 3. Probing depths > 5 mm in at least one site in each quadrant 4. Radiologically detectable alveolar bone loss in all quadrants 5. Good general health |
| Key exclusion criteria | 1. Pregnant 2. Systemic or local antimicrobial treatment in the preceding 6 months 3. Periodontal treatment in the preceding 6 months 4. The presence of an infectious disease, chronic pulmonary disease, cancer or diabetes and other apparent oral infections 5. Intake of immunosuppressive medication or immunodeficiency |
| Date of first enrolment | 14/02/2015 |
| Date of final enrolment | 01/03/2016 |
Locations
Countries of recruitment
- Austria
Study participating centre
Vienna
1090
Austria
Sponsor information
University/education
Spitalgasse 23
Vienna
1090
Austria
| Website | https://www.meduniwien.ac.at/web/en/ |
|---|---|
"ROR" |
https://ror.org/05n3x4p02 |
Funders
Funder type
Not defined
Government organisation / Local government
- Alternative name(s)
- Medical University of Vienna, MediUni Wien
- Location
- Austria
Results and Publications
| Intention to publish date | 10/10/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
