Periodontitis
Conditions
Keywords
Periodontitis, Non-surgical therapy, Chlorhexidine, Mouthwash, Plaque, Randomized trial
Brief summary
The goal of the following clinical trial is to compare the efficacy of a product based on chlorhexidine 0.12% and CITROX and the same product without CITROX in the healing phenomena that occur after non-surgical periodontal therapy. The main questions it aims to answer are: * Is the response to periodontal therapy better if mouthwashes containing bioflavonoids are used as a support to non surgical periodontal therapy? * What is the patients' perception? Participants, divided into 2 groups, are asked to use either one or the other mouthwash for 14 days after non-surgical periodontal therapy.
Detailed description
At baseline, all participants underwent received comprehensive periodontal examination, full-mouth intraoral radiographic analysis and received oral hygiene instruction. All treatments were performed by the same experienced clinician (M.G.L.) After completing NSPT, patients were randomly assigned to the test- or control group through an online random number generator (random.org; www.random.org). Test group participants received a 300 ml bottle of mouthwash containing 0,12% CHX combined with organic acids and bioflavonoids, while the control group received a 300 ml bottle of 0.12% CHX mouthwash. Both bottles were unlabeled to prevent identification by either the patients or the clinician. All participants were instructed to rinse with the undiluted mouthwash twice daily (morning and evening) for 60 seconds over 14 days following subgingival instrumentations. This regimen aligns with the standard use of chlorhexidine mouthwashes. Oral hygiene instructions were provided after both supragingival debridement and subgingival instrumentations with additional training in the use of interdental devices as necessary. Patients were recalled for follow-up assessments at 14 days (T2), 2 months (T3) and 6 months (T4). In these sessions, oral hygiene instructions were reinforced as needed. During the follow-up, no additional periodontal treatments were performed. Patients were subsequently enrolled in a maintenance care program, involving routine professional cleanings every 6 months. Data collected from baseline (T0) to 6 months (T4) were used for the present analysis.
Interventions
DEVICEMouthwash with chlorhexidine 0,12% and CITROX
Patients use the undiluted mouthwash 2 times a day for 14 days after performing normal brushing.
DEVICEMouthwash with chlorhexidine 0,12%
Patients use the undiluted mouthwash 2 times a day for 14 days after performing normal brushing.
Sponsors
University of L'Aquila
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ASA I and ASA II patients; * Age \> 21 years; * Non-smokers or smokers \< 5 cig/day; * Presence of periodontal disease; * \>10 natural teeth; * At least 2 teeth with pockets ≥5mm; * Indications for carrying out at least one SRP (scaling and root planing) session; * Signing of the written informed consent to participate in the study.
Exclusion criteria
* Severe general medical pathologies; * Immunodeficiency states; * Radiotherapy in the head and neck region; * Uncontrolled diabetes or hypertension; * Smokers \>5 cigs/day; * Impossibility to carry out homogeneous and continuous follow-up; * Documented allergy to chlorhexidine or hyaluronic acid; * Taking drugs that cause alterations in the gums and oral mucosa; * Pregnancy or breastfeeding; * Presence of removable prostheses; * Periodontal treatment in the previous 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Full mouth bleeding score (FMBS) | baseline, 14 days, 2 months, 6 months | The FMBS indicate the percentage of bleeding sites out of the total. |
| Full mouth plaque score (FMPS) | baseline, 14 days, 2 months, 6 months | The FMPS indicate the percentage of sites with plaque out of the total. |
| Probing Depth (PD) | baseline, 2 months, 6 months | Effects on post-treatment healing: the Probing Depth was measured in mm |
| Gingival Index (GI) | baseline, 14 days, 2 months, 6 months | Effects on post-treatment healing: the GI was assessed with values between 0 and 3 (0- best one, 3 worst one) |
| Plaque Index (PI) | baseline, 14 days, 2 months, 6 months | Effects on post-treatment healing: the GI was assessed with values between 0 and 3 (0- best one, 3 worst one) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcome Measure (PROMS) | 2 weeks post non-surgical periodontal therapy | Visual Analogue Scale (VAS) in the form of a questionnaire to evaluate post-op pain, post-op sensitivity, taste alteration, appearance of staining and pleasantness of the mouthrinse used. The minimum value is 0 while the maximum value is 10. For all questions the best value is 0 and the worst 10, except for pleasantness. |
Countries
Italy
Outcome results
None listed