Plain English Summary
Background and study aims
Severe forms of periodontal (gum) disease require additional systemic antibiotics as well as the usual non-surgical periodontal therapy (subgingival instrumentation). However, in light of the wolrdwide increasing problem of microbial resistance towards antibiotics, it is important to find alternatives to systemic antibiotics. Locally administered doxycycline or photodynamic therapy has been already investigated in the treatment of periodontal diseases, but no direct comparison has been performed until now. Thus, the aim of this study is to evaluate the effectiveness of locally administered doxycycline or photodynamic therapy in persistent periodontal pockets in periodontal patients.
Who can participate?
Patients aged over 18 who had been previously treated for periodontitis with persistent sites of inflammation
What does the study involve?
The study involves periodontal non-surgical treatment with conventional methods (ultrasonics). All patients will be divided into three treatment groups: one group receives after mechanical treatment two sessions of photodynamic therapy at persistent inflamed periodontal pockets, the second group will receive in the inflamed pockets a paste containing doxycycline, while the third group will not receive any additional treatment. The researchers evaluate the effectiveness of the treatment by measuring clinical parameters (probing depth, attachment level, bleeding on probing) and determining the quantity of certain periodontal pathogens as well as inflammatory markers. All these will be determined before and 3, 6 and 12 months after therapy.
What are the possible benefits and risks of participating?
The benefits are optimal periodontal treatment performed by a periodontal specialist, as well as obtaining additional microbiological and immunological data related to effectiveness of the treatment. There are no expected side-effects since this is the least invasive periodontal treatment.
Where is the study run from?
University Iuliu-Hatieganu Cluj-Napoca (Romania)
When is the study starting and how long is it expected to run for?
March 2015 to October 2020
Who is funding the study?
1. Investigator initiated and funded
2. Brendent Dental GmbH (Germany)
Who is the main contact?
Dr Raluca Cosgarea
ralucacosgarea@gmail.com
Study website
Contact information
Type
Scientific
Contact name
Dr Raluca Cosgarea
ORCID ID
http://orcid.org/0000-0003-2148-9645
Contact details
Clinic for Prosthodontics
Str Clinicilor 32
Cluj-Napoca
400506
Romania
+40 (0)751638904
raluca.cosgarea@ukbonn.de
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
ClinicalTrials.gov number
Nil known
Protocol/serial number
#390/02.07.2015
Study information
Scientific title
Clinical and microbiological evaluation of local doxycycline and antimicrobial photodynamic therapy during supportive periodontal therapy: a randomized clinical trial
Acronym
HelLig
Study hypothesis
Photodynamic therapy (PDT) or antibiotic local-drug-delivery (LDD) provide similar clinical results in persistent/recurrent periodontal pockets of periodontal patients enrolled in supportive periodontal therapy.
Ethics approval(s)
Approved 02/07/2015, ethical committee of the Faculty of Medicine and Pharmacy, University Iuliu Hatieganu Cluj-Napoca (Comisia de etica UMF Iuliu Hatieganu Cluj-Napoca, Str. Victor Babes nr 8, Cluj-Napoca, Romania; +40 (0)264 597256; etica.cercetare@umfcluj.ro), ref: #390/02.07.2015
Study design
Randomized controlled clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
See additional file ISRCTN17209965_PIS (added 01/03/2021)
Condition
Persistent/recurrent periodontal pockets of patients with periodontal disease
Intervention
Periodontitis patients enrolled in supportive periodontal therapy are randomly treated as follows:
Group A (n=35): subgingival instrumentation (SI) + photodynamic therapy (PDT) and 7 days later 2nd PDT
Group B (n=35): SI + locally delivered doxycycline) LDD
Group C (n=35): SI (control)
Prior to intervention and at 3, 6 and 12 months after therapy, probing pocket depths, clinical attachment level, number of treated sites with bleeding on probing (nBOP), full-mouth-plaque and bleeding-scores (gingival-bleeding-index, %BOP) will be recorded and analyzed. At the same time points, eight periodontopathogens and immunomarkers will quantitatively determined.
Intervention type
Mixed
Primary outcome measure
Number of bleeding sites measured with a mm-scaled periodontal probe and noted on patient files at baseline prior to therapy and at 3, 6 and 12 months
Secondary outcome measures
Measured at baseline prior to therapy and at 3, 6 and 12 months:
1. Probing pocket depth measured with a mm-scaled periodontal probe and noted on patient files
2. Clinical attachment level measured with a mm-scaled periodontal probe and noted on patient files
3. Bleeding indexes measured with a mm-scaled periodontal probe and noted on patient files
4. Plaque indexes assessed dichotomously on patient data sheets after plaque coloration with a disclosing dye
5. Periodontal pathogens measured using real-time PCR
6. Immunomarkers from the sulcus measured using ELISA test
Overall study start date
10/03/2015
Overall study end date
01/10/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Minimum age 25 years
2. Patients should be enrolled in a regular maintenance program (after completion of active periodontal therapy)
3. Diagnoses of chronic periodontitis
4. Minimum one site per quadrant with PD ≥4 mm and BOP+
5. Good level of oral hygiene [plaque control record (PCR) after O’Leary 1972 ≤30%]
6. Systemically healthy: no history of diseases that may influence the severity or progression of the periodontal disease (Down syndrome, HIV, diabetes mellitus type 1 and 2), post-irradiation in the head and neck area, infectious diseases or heart diseases that need a prophylactic antibiosis before dental treatments, liver diseases
7. Informed written consent
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
105
Total final enrolment
105
Participant exclusion criteria
1. Systemic or local use of antibiotics within the preceding 3 months
2. Medication that may interact with doxycyclin (e.g., coumarin derivates, containing alcohol derivates, 5-fluorouracil/ disulfiram derivates, amprenavir oral solutions, lopinavir/ritonavir oral solution)
3. Medication that may influence the periodontium: cyclosporin A, compounds of phenytoin, calcium channel blockers (nifedipine, verapamil, amlodipine, diltiazem)
4. Pregnancy or lactation
5. Patients who don’t match the inclusion criteria
Recruitment start date
01/10/2015
Recruitment end date
01/10/2017
Locations
Countries of recruitment
Romania
Study participating centre
University Iuliu-Hatieganu Cluj-Napoca
Policlinic of prosthodontics
Str. Clinicilor nr 32
Cluj-Napoca
400506
Romania
Sponsor information
Organisation
Iuliu Hațieganu University of Medicine and Pharmacy
Sponsor details
str. Pasteur nr. 4 etaj 2
Cluj-Napoca
400506
Romania
+40 (0)374834115
decanat_stoma@umfcluj.ro
Sponsor type
University/education
Website
ROR
Organisation
University of Bern
Sponsor details
Clinic of Periodontology
Dental School
Bern
3010
Switzerland
+41 (0)31 632 25 77
anton.sculean@zmk.unibe.ch
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Brendent Dental GmbH
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
1. Two publications
2. Oral presentation at dental congresses
Intention to publish date
01/10/2021
Individual participant data (IPD) sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Raluca Cosgarea (ralucacosgarea@gmail.com)
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 01/03/2021 | No | Yes | ||
| Protocol file | 01/03/2021 | No | No | ||
| Results article | 3 and 6 months results | 09/03/2021 | 28/10/2021 | Yes | No |
| Results article | 12 months results | 30/05/2022 | 30/03/2023 | Yes | No |
Additional files
- ISRCTN17209965_PIS.pdf Uploaded 01/03/2021
- ISRCTN17209965_PROTOCOL.pdf Uploaded 01/03/2021