Periodontal Disease, Periodontal Disease, AVDC Stage 3, Periodontal Disease Stage 2
Conditions
Keywords
periodontal disease, Nspt, scaling and root planing
Brief summary
The study aims to compare the efficacy of a novel mouthwash based on microRepair ABX and an antibacterial complex with that of 0.12% chlorhexidine, both used as adjuncts to scaling and root planing.
Detailed description
This study will be conducted in the Department of Odontostomatological and Maxillofacial sciences, in the Screening and Prevention Unit directed by me. Study Population Subjects diagnosed with periodontal disease and requiring non-surgical periodontal therapy were enrolled. Sample Size A total of 40 patients were included in the study, with 20 subjects allocated to each treatment group. Group A- TEST GROUP: NSPT+ ABX; GROUP B- CONTROL GROUP: NSPT+ CHX. All participants underwent a comprehensive periodontal examination, including full-mouth periodontal charting. Standardized intraoral periapical radiographs were obtained using positioning devices to assess radiographic bone loss. All patients subsequently received non-surgical periodontal therapy (NSPT) following a full-mouth disinfection protocol, performed with both hand and ultrasonic instruments. Oral hygiene instructions were reinforced at each scheduled visit. A first re-evaluation was conducted at 8 weeks, and a second re-evaluation at 6 months to assess periodontal stability. Patients in the control group received NSPT in combination with a 0.12% chlorhexidine mouthwash, administered twice daily for 60 seconds over a 14-day period starting immediately after completion of mechanical instrumentation. Patients in the test group received NSPT in combination with a high-density Biorepair Plus mouthwash, administered twice daily for 60 seconds over a 14-day period starting immediately after completion of mechanical instrumentation
Interventions
OTHERABX Mouthwash as adjunctive to non surgical periodontal treatment
Group A: a novel mouthwash with microRepair ABX will be used for the first timen in adjunct to non surgical periodontal therapy
OTHERCHX as adjunctive to non surgical periodontal treatment
Group B - chlorhexidine mouthwash in adjunct to nonsurgical periodontal therapy
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with Stage I, II and III periodontal disease; 2. Age between 30 and 70 years; 3. ASA I or II patients; 4. Light smokers (\<10 cigarettes per day); 5. Patients not already using the study products
Exclusion criteria
1. Patients with Stage IV periodontal disease; 2. HbA1c \> 7% 3 ASA \> III 4 Severe smokers 5 Patients already using the study products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probing depth | From enrollment to the end of treatment at 12 weeks and at 24 weeks | Probing Depth (PD), measured in millimeters (mm) using a PCP 15 UNC periodontal probe. PD represents the distance from the gingival margin to the base of the periodontal pocket. The measurement range is from 0 to 15 mm. Higher values indicate deeper periodontal pockets and a worse periodontal condition. |
| full mouth bleeding score | from baseline to 12 and 24 weeks after full mouth disinfection | Full Mouth Bleeding Score (FMBS), expressed as the percentage (%) of sites exhibiting bleeding on probing out of the total number of sites examined. The scale ranges from 0% to 100%, where higher percentages indicate more gingival inflammation and a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical attachment level - CAL | From baseline to 12 and 24 weeks after full mouth disinfection | Clinical Attachment Level (CAL), measured in millimeters (mm) using a PCP 15 UNC periodontal probe. CAL represents the distance from the cemento-enamel junction (CEJ) to the base of the periodontal pocket. The measurement range is from 0 to 15 mm. Higher values indicate greater attachment loss and a worse periodontal outcome |
| Full mouth plaque score | from baseline to 12 and 24 weeks after full mouth disinfection | Full Mouth Plaque Score (FMPS), expressed as the percentage (%) of sites with visible plaque out of the total number of sites examined. The scale ranges from 0% to 100%, where higher percentages indicate poorer oral hygiene and a worse outcome. |
| dentin hypersensitivity | baseline, 12 weeks and 24 weeks | dentin hypersensitivity measured using a VAS followingair stimulus |
| Patient satisfaction | 2 weeks after the non surgical periodontal treatment | Patient satisfaction, assessed using a structured questionnaire evaluating comfort, perceived effectiveness, and overall satisfaction with the treatment. Each item is recorded as a dichotomous response (Yes/No). Responses are summarized as the percentage (%) of positive ("Yes") answers out of the total number of questions. The scale ranges from 0% to 100%, where higher percentages indicate greater patient satisfaction and a better outcome. |
Countries
Italy
Outcome results
None listed