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Exploring the impact of antimicrobial treatments combined with dental cleaning on gum disease patients

The use of a local desiccant antimicrobial agent in periodontal therapy: a randomized clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14161265
Enrollment
60
Registered
2025-05-21
Start date
2024-12-12
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Periodontitis Oral Health

Interventions

Each patient will receive an initial complete full-mouth clinical examination, excluding wisdom teeth (baseline assessment). Periodontal examinations will be performed in the clinic setting with stand
stage II (moderate) periodontitis
stage III and stage IV (severe and very severe) periodontitis. Cases that do not meet periodontitis case definition criteria will be classified as either gingivitis or periodontally healthy cases. A

Sponsors

Iuliu Ha?ieganu University of Medicine and Pharmacy
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Periodontitis stage III-IV 2. Good systemic health 3. Age>18 years 4. Minimum 5 natural teeth per quadrant 5. A minimum of 2 sites on different teeth with a pocket probing depth (PD)>4 mm

Exclusion criteria

Exclusion criteria: 1. Periodontal and/or antibiotic therapy within the last 6 months 2. Use of antiseptic mouthwashes in the last 3 months 3. Pregnancy 4. Severe systemic conditions 5. Immunosuppressive therapy/current radiotherapy

Design outcomes

Primary

MeasureTime frame
Measured at baseline and follow up: 1. Probing depth (PD) is measured using a periodontal probe at six sites per tooth 2. Gingival recession (GR) is measured using a periodontal probe at six sites per tooth 3. Clinical attachment loss (CAL) is measured using a periodontal probe at six sites per tooth 4. Gingival Bleeding Index (GBI) is measured using the presence of bleeding upon probing at four sites per tooth and calculated as a percentage of bleeding sites over total sites 5. Oral Hygiene Index (IHI) is measured using the presence of visible dental plaque at four sites per tooth and calculated as a percentage of plaque-positive sites over total sites 6. Change in total probing depth (PD) is measured using a periodontal probe at six sites per tooth and compared between intervention groups

Secondary

MeasureTime frame
Measured at baseline and follow up: 1. Total probing depth (PD) is measured using a periodontal probe at six sites per tooth, calculating the average of all sites evaluated 2. Interproximal probing depth (PD) is measured using a periodontal probe at six sites per tooth, calculating the average of interproximal sites evaluated 3. Total clinical attachment loss (CAL) is measured using a periodontal probe at six sites per tooth, calculating the average of all sites evaluated 4. Interproximal clinical attachment loss (CAL) is measured using a periodontal probe at six sites per tooth, calculating the average of interproximal sites evaluated 5. Count of total probing depths equal to 5 mm is measured using a periodontal probe at six sites per tooth, summing the number of sites with PD = 5 mm 6. Count of interproximal probing depths equal to 5 mm is measured using a periodontal probe at six sites per tooth, summing the number of interproximal sites with PD = 5 mm 7. Count of total probing depths greater than or equal to 6 mm is measured using a periodontal probe at six sites per tooth, summing the number of sites with PD = 6 mm 8. Count of interproximal probing depths greater than or equal to 6 mm is measured using a periodontal probe at six sites per tooth, summing the number of interproximal sites with PD = 6 mm 9. Oral Hygiene Index (IHI) score is measured using a dental plaque detector at four sites per tooth, calculated as the percentage of plaque-positive sites over total sites 10. Gingival Bleeding Index (GBI) score is measured using a periodontal probe at four sites per tooth, calculated as the percentage of bleeding sites over total sites

Countries

Romania

Contacts

Public ContactIulia Roxana Costin (Maniac-Costin)
costin_iulia_roxana@elearn.umfcluj.ro+40 753149589

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026