Evaluation of antimicrobial photodynamic therapy and doxycycline during supportive periodontal therapy
| ISRCTN | ISRCTN17209965 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17209965 |
| Secondary identifying numbers | #390/02.07.2015 |
- Submission date
- 22/02/2021
- Registration date
- 24/02/2021
- Last edited
- 30/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
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
Contact information
Scientific
Clinic for Prosthodontics
Str Clinicilor 32
Cluj-Napoca
400506
Romania
 ORCID ID |
0000-0003-2148-9645 |
|---|---|
| Phone | +40 (0)751638904 |
| raluca.cosgarea@ukbonn.de |
Study information
| Study design | Randomized controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN17209965_PIS.pdf |
| Scientific title | Clinical and microbiological evaluation of local doxycycline and antimicrobial photodynamic therapy during supportive periodontal therapy: a randomized clinical trial |
| Study 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 |
| 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 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 105 |
| Total final enrolment | 105 |
| 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 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
Str. Clinicilor nr 32
Cluj-Napoca
400506
Romania
Sponsor information
University/education
str. Pasteur nr. 4 etaj 2
Cluj-Napoca
400506
Romania
| Phone | +40 (0)374834115 |
|---|---|
| decanat_stoma@umfcluj.ro | |
| Website | http://www.umfcluj.ro/en/ |
"ROR" |
https://ror.org/051h0cw83 |
University/education
Clinic of Periodontology
Dental School
Bern
3010
Switzerland
| Phone | +41 (0)31 632 25 77 |
|---|---|
| anton.sculean@zmk.unibe.ch | |
| Website | http://www.unibe.ch/eng/ |
Funders
Funder type
Industry
No information available
No information available
Results and Publications
| Intention to publish date | 01/10/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. Two publications 2. Oral presentation at dental congresses |
| 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) |
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
Editorial Notes
30/03/2023: Publication reference added.
27/10/2021: The following changes have been made:
1. Publication reference added.
2. The study contact has been updated.
01/03/2021: The following changes have been made:
1. Uploaded protocol (not peer reviewed) as an additional file.
2. Uploaded participant information sheet as an additional file.
23/02/2021: Trial's existence confirmed by the ethical committee of the Faculty of Medicine and Pharmacy, University Iuliu Hatieganu Cluj-Napoca.
