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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10470122
Enrollment
45
Registered
2024-03-13
Start date
2021-09-01
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis stages III-IV Oral Health

Interventions

45 patients were randomly divided into two groups control (subgingival instrumentation chlorhexidine-assisted) and test (antiviral medication, subgingival instrumentation with povidone-iodine, sodium

Sponsors

Victor Babe? University of Medicine and Pharmacy Timi?oara
Lead Sponsor

Eligibility

Sex/Gender
All
Age
33 Years to 71 Years

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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. 2. Bleeding on probing (BOP) was assessed dichotomously in 6 sites per tooth, using a periodontal probe (Force-Control Periodontal Probe WHO DB765R, Aesculap, Tuttlingen, Germany). 3. Recession (REC) were recorded to the nearest millimeter at six sites per tooth. 4. The clinical attachment level (CAL) was calculated using the PD and REC values. Measurements were rounded up to the next whole millimeter value. At the proximal surfaces, the evaluation was done in the proximity of the dental contact point, with moderate pressure. For all clinical measurements the probing force was 0.2N (20 g) using the same standardized periodontal probe. 5. Mobility was recorded in degrees, according to the Miller classification system (1985) (40). The periodontal parameters were recorded in the periodontal chart (http://www.periodontalchart-online.com/uk/), saved in .pdf format, printed and included into each patient’s observation file. Other secondary outcomes: 6. Microbiological data: In the same appointment, bacterial samples were taken as described below: to detect the 5 major keystone bacteria, Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas gingi-valis (Pg), Prevotella intermedia (Pi), Tanererella forsythia (Tf), and Treponema denticola (Td), a molecular genetic analysis was performed, using the commercial kit micro-IDent plus (Hain Lifescience GmbH). During the initial evaluation, samples of subgingival plaque were collected from the deepest periodontal pockets in each quadrant and used to identify the existing bacterial strains prior to treatment. This protocol was repeated at the three- month re-evaluation to assess post treatment bacterial suppression. Samples wer

Countries

Romania

Contacts

Public ContactMarius Boariu
boariu.marius@umft.ro+40 722701871

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 17, 2026