Clinical, microbiological and enzymatic evaluation after "Clean&Seal® protocol in subgingival instrumentation in severe periodontitis (C&S-STEP2)

Clinical, microbiological and enzymatic evaluation of hyaluronic acid used in the "Clean&Seal®" protocol in step 2 of the therapy of the severe and the advanced periodontitis

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17852953

Enrollment

Registered

2024-11-29

Start date

2024-11-15

Completion date

Unknown

Last updated

2025-01-06

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

Conditions

Severe and advanced periodontitis Oral Health

Interventions

Participants will be randomly assigned to one of three groups: test group 1 will receive treatment with hyaluronic acid and hypochlorite gel

test group 2 will use hypochlorite gel alone, and group 3 (control) will receive a placebo gel. Subgingival instrumentation will be performed under local anesthesia using ultrasonic and manual instrum

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult patients aged 18 - 65 years 2. At least 10 remaining teeth in oral cavity 3. Presence of minimum 4 sites with periodontal pockets =5mm, with positive BOP, radiographic bone loss =3mm

Exclusion criteria

Exclusion criteria: 1. Molars with furcation involvement class II or III 2. Endodontic lesions 3. Severe occlusal dysfunction 4. Antibiotic treatment 3 months prior to the start of the trial or during study participation 5. Systemic diseases that may influence the outcome of periodontal therapy (e.g., uncontrolled diabetes prior to or during study participation) 6. Immunocompromised patients 7. Allergic patients to NaOCl 8. Pregnant and breastfeeding women

Design outcomes

Primary

Measure	Time frame
Probing depth (PD) is measured using a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing Co., Chicago, IL, USA) at baseline and 3 months post-therapy	—

Secondary

Measure	Time frame
1. Full mouth plaque score (FMPS) is measured using a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing Co., Chicago, IL, USA) at baseline and 3 months post-therapy 2. Full mouth bleeding score (FMBS) is measured using a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing Co., Chicago, IL, USA) at baseline and 3 months post-therapy 3. Clinical attachment loss (CAL) is measured using a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing Co., Chicago, IL, USA) at baseline and 3 months post-therapy 4. Gingival recession (GR) is measured using a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing Co., Chicago, IL, USA) at baseline and 3 months post-therapy 5. Bacterial pathogens are quantitatively evaluated using PCR testing at baseline and 3 months post-therapy from sites with the highest probing pocket depth (PPD) 6. MMP-8 and IL-1 levels are analyzed using dento-ELISA immunoassay at the University Department of Biochemistry at UMVBT from gingival crevicular fluid samples collected at baseline and 3 months post-treatment from the site with the deepest probing depth 7. Inflammatory status is assessed histologically by analyzing gingival biopsies harvested using micro-tissue punches at baseline and 3 months post-treatment to determine the amount of inflammatory cells and describe the characteristics of intercellular substance in relation to the clean and seal protocol	—

Measure

Time frame

1. Full mouth plaque score (FMPS) is measured using a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing Co., Chicago, IL, USA) at baseline and 3 months post-therapy 2. Full mouth bleeding score (FMBS) is measured using a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing Co., Chicago, IL, USA) at baseline and 3 months post-therapy 3. Clinical attachment loss (CAL) is measured using a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing Co., Chicago, IL, USA) at baseline and 3 months post-therapy 4. Gingival recession (GR) is measured using a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing Co., Chicago, IL, USA) at baseline and 3 months post-therapy 5. Bacterial pathogens are quantitatively evaluated using PCR testing at baseline and 3 months post-therapy from sites with the highest probing pocket depth (PPD) 6. MMP-8 and IL-1 levels are analyzed using dento-ELISA immunoassay at the University Department of Biochemistry at UMVBT from gingival crevicular fluid samples collected at baseline and 3 months post-treatment from the site with the deepest probing depth 7. Inflammatory status is assessed histologically by analyzing gingival biopsies harvested using micro-tissue punches at baseline and 3 months post-treatment to determine the amount of inflammatory cells and describe the characteristics of intercellular substance in relation to the clean and seal protocol

—

Countries

Romania

Contacts

Public ContactElena Catana

elena.catana@umft.ro+40 745649445

Outcome results

None listed

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