Condition category
Digestive System
Date applied
24/07/2018
Date assigned
02/08/2018
Last edited
01/08/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Selma Husejnagic

ORCID ID

http://orcid.org/0000-0001-8727-8205

Contact details

Sensengasse 2 A
Vienna
1090
Austria

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EK Nr: 1860/2014

Study information

Scientific title

Photoactivated Disinfection with a Light-Emitting Diode in Periodontal Treatment – a Randomized Controlled Clinical Split-mouth Trial

Acronym

PADLED

Study hypothesis

Adjunctive Photoactivated Disinfection with a red LED has an additional beneficial effect in treatment of chronic periodontitis.

Ethics approval

Ethikommission Medizinische Universität Wien, 13/02/2015, 1860/2014

Study design

Interventional single-centre randomised split-mouth randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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

Phase

Drug names

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 trial start date

01/10/2014

Overall trial end date

30/06/2016

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

20

Participant 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

Recruitment start date

14/02/2015

Recruitment end date

01/03/2016

Locations

Countries of recruitment

Austria

Trial participating centre

Medical University of Vienna
Spitalgasse 23
Vienna
1090
Austria

Sponsor information

Organisation

Medical University of Vienna

Sponsor details

Spitalgasse 23
Vienna
1090
Austria

Sponsor type

University/education

Website

https://www.meduniwien.ac.at/web/en/

Funders

Funder type

Not defined

Funder name

Medizinische Universität Wien

Alternative name(s)

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Austria

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

10/10/2018

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes