Severe and advanced periodontitis Oral Health
Conditions
Interventions
Subgingival re-instrumentation with adjunctive sodium hypochlorite gel and hyaluronic acid
For each participant will be recorded age, gender, smoking status, and presence/absence of a well-controlled
test group 2 will use Perisolv® alone
and a placebo group will receive a placebo gel. Subgingival instrumentation will be performed under local anesthesia using ultrasonic and manual methods, with protocol-specific gel applications preced
Sponsors
Victor Babe? University of Medicine and Pharmacy Timi?oara
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with stage III and IV periodontitis 2. Achieved the first and the second steps of periodontal therapy 3. At least 10 remaining teeth in the oral cavity 4. Presence of minimum 4 sites with moderate periodontal pockets 4-5 mm 5. Positive BOP 6. Radiographic bone loss =3 mm
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 (ex. 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 |
|---|---|
| Periodontal probing depth (PPD) measured using a periodontal probe at baseline and 3 months post-therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. FMPS (full mouth plaque score), FMBS (full mouth bleeding score), CAL (clinical attachment loss), PD (probing depth), GR (gingival recession) measured using a periodontal probe at baseline and 3 months post-therapy 2. Quantitative evaluation of bacterial pathogens will be performed at baseline and three months post-therapy, from sites with the highest PPD (probing pocket depth), using PCR testing 3. MMP-8 and IL-1 analysis in samples of gingival crevicular fluid collected from the site with the deepest probing depth measured using dento-ELISA immunoassay at baseline and three months post-treatment and sent to the laboratories of the University Department of Biochemistry at UMVBT 9. To histologically assess the inflammatory status, gingival biopsies will be harvested from areas posing no esthetic or functional risk using micro-tissue punches and will be analyzed at baseline and three months post-treatment, to determine the amount of inflammatory cells and to describe the characteristics of intercellular substance to the clean and seal protocol | — |
Countries
Romania
Contacts
Public ContactElena Catana
Outcome results
None listed