A cost-effective method utilizing both povidone-iodine irrigations and sodium hypochlorite rinsing solution as supplementary measures in treating severe gum disease, aimed at reducing bacterial infections in patients
| ISRCTN | ISRCTN10470122 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10470122 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 01/2020/PERIO |
| Sponsor | Victor Babeș University of Medicine and Pharmacy Timișoara |
| Funder | Investigator intiated and funded |
- Submission date
- 13/03/2024
- Registration date
- 13/03/2024
- Last edited
- 04/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Severe cases of gum disease, known as periodontitis, often do not respond well to typical treatments due to the presence of bacteria and viruses. Simply using mechanical methods to clean the gums may not be enough to remove a significant amount of these harmful microorganisms, especially in deep gum pockets.
The goal of this study is to compare the effectiveness of a low-cost treatment method using povidone-iodine and sodium hypochlorite solutions alongside regular gum cleaning, with the more commonly used Chlorhexidine solution, in patients with advanced stage IV periodontitis. The study aims to assess both the clinical outcomes (how the patients' gums look and feel) and the microbiological outcomes (the levels of harmful bacteria) of these different treatment approaches.
Who can participate?
Patients who are generally healthy and have been diagnosed clinically with severe stages of gum disease, specifically stage III and IV, with grades B and C severity, as defined by the Classification of Periodontal and Peri-implant Diseases and Conditions in 2018.
What does the study involve?
Forty-five patients were randomly assigned to one of two groups: the control group, where subgingival cleaning was done with the help of chlorhexidine, and the test group, where antiviral medication was used alongside subgingival cleaning with povidone-iodine, sodium hypochlorite rinsing, and antibiotics. Clinical evaluations and analysis of the bacteria present were conducted at the beginning of the study and again after three months.
What are the possible benefits and risks of participating?
The possible benefits are substantial improvements in clinical and microbiological parameters, when compared with the current antimicrobial recommendations.
There are no risks involved for the participants.
Where is the study run from?
Victor Babeș University of Medicine and Pharmacy Timișoara (Romania)
When is the study starting and how long is it expected to run for?
January 2019 to November 2023
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Prof. Marius Boariu, boarium@yahoo.com
Contact information
Public, Scientific, Principal investigator
Bv.Revolutiei de la 1989, 9
Timișoara
300070
Romania
| 0000-0001-6184-3704 | |
| Phone | +40 722701871 |
| boariu.marius@umft.ro |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-blind randomized controlled trial interventional single-center |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A low-cost protocol using the adjunctive action of povidone-iodine irrigations and sodium hypochlorite rinsing solution to Step 2 of periodontal therapy for patients with stage III-IV periodontitis. A single-blind randomized controlled trial |
| Study acronym | LOW-COST-STEP-II |
| Study objectives | The hypothesis of the study is that a complex treatment protocol including low-cost potent antimicrobials, antivirals and antibiotics, as adjunctive to subgingival instrumentation, will result in better clinical and microbiological outcomes than the traditional subgingival instrumentation, in patients with severe periodontitis. |
| Ethics approval(s) |
Approved 12/10/2020, The Research Ethics Committee of the ‘Victor Babeş’ University of Medicine and Pharmacy Timisoara (Pta Eftimie Murgu nr. 2, Timișoara, 300041, Romania; +40 256204400; esanda2000@yahoo.com), ref: 56/2020 |
| Health condition(s) or problem(s) studied | Periodontitis stages III-IV |
| Intervention | 45 patients were randomly divided into two groups control (subgingival instrumentation chlorhexidine-assisted) and test (antiviral medication, subgingival instrumentation with povidone-iodine, sodium hypochlorite rinsing solution and antibiotics). Clinical measurements and microbiological analysis were performed at baseline and after three months. |
| Intervention type | Mixed |
| Primary outcome measure(s) |
Pocket Depth (PD) reduction. PDs were measured at six sites/tooth using a PCP-UNC calibrated probe (Hu-Friedy, Chicago, IL, USA), at baseline and after 3 months. |
| Key secondary outcome measure(s) |
1. Full-mouth plaque scores (FMPS) were recorded using six sites per tooth. The presence of plaque was determined using disclosure solution (Dentorama Blue Disclosing Pellets Pro-155, Svenska Dentorama AB, Solna/Stockholm, Sweden), in a dichotomic way, with regard to the percentage of sites with plaque. |
| Completion date | 30/11/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 33 Years |
| Upper age limit | 71 Years |
| Sex | All |
| Target sample size at registration | 45 |
| Total final enrolment | 45 |
| Key inclusion criteria | Systematically healthy patients with the clinical diagnosis of periodontitis stage III and IV, grades B and C, according to the Classification of Periodontal and Peri-implant Diseases and Conditions 2018. |
| Key exclusion criteria | Current exclusion criteria as of 12/04/2024: 1. Patients who underwent antibiotic, anticoagulant or immunosuppressive therapy during the preceding 6 months 2. Patients who used oral antiseptics or received any periodontal therapy 3. Pregnant or lactating women 4. Patients in need of antibiotic prophylaxis during the preceding six months 5. Hypersensitivity against PVP-iodine and NaOCl 6. Thyroid dysfunction 7. Patients with allergies to the recommended medications 8. Systemic disorders 9. Smokers ( ≥ 10 cigarettes per day) _____ Previous exclusion criteria: 1. Patients who underwent antibiotic, anticoagulant or immunosuppressive therapy during the preceding 6 months 2. Patients who used oral antiseptics or received any periodontal therapy 3. Pregnant or lactating women 4. Patients in need of antibiotic prophylaxis during the preceding six months 5. Hypersensitivity against PVP-iodine and NaOCl 6. Thyroid dysfunction 7. Patients with allergies to the recommended medications 8. Systemic disorders 9. Non-smokers and smokers (≤ 10 and ≥ 10 cigarettes per day) were included, and a separate analysis was carried out for each category. |
| Date of first enrolment | 01/09/2021 |
| Date of final enrolment | 01/03/2023 |
Locations
Countries of recruitment
- Romania
Study participating centre
Timișoara
300070
Romania
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| IPD sharing plan | The datasets generated during the current study will be available upon request from Prof. Marius Boariu, boarium@yahoo.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other unpublished results | version 1 | 20/03/2024 | 04/06/2024 | No | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN10974027 Synopsis CT026_004 CSR v1 - 20 Mar 2024_redacted.pdf
- Other unpublished results
Editorial Notes
04/06/2024: A results file was uploaded.
12/04/2024: The exclusion criteria were changed.
13/03/2024: Trial's existence confirmed by The Research Ethics Committee of the ‘Victor Babeş’ University of Medicine and Pharmacy Timisoara.