Gingivitis, Gum Disease, Oral Health
Conditions
Keywords
Gingivitis, Gum disease, Oral health, Full mouth bleeding score, Full mouth plaque score
Brief summary
The aim of the study was to assess the acceptability of the assisted individual and compliance with home use, as well as their clinical impact on the plaque index (PI) and bleeding on probing (BOP), with monthly reassessments allowing for continuous monitoring of all parameters.
Detailed description
The study was conducted as a randomized controlled clinical trial with a crossover design in patients affected by gingivitis. All data were anonymized by assigning a unique identification code to each participant. Subjects were selected according to predefined inclusion and exclusion criteria. Patients aged between 18 and 65 years with interdental spaces suitable for the use of interdental brushes were included. At baseline (T0), all patients underwent a periodontal clinical examination, including assessment of clinical indices and documentation of initial conditions. A professional oral hygiene session was also performed using ultrasonic instruments and air flow with glycine powder. Patients received instructions for home oral hygiene using a two-tone plaque disclosing agent to highlight areas of greater cleaning difficulty. Initial intraoral conditions were documented photographically. At the end of the session, each patient was assigned to one of two treatment groups. Randomization was performed by coin toss. All patients were provided with a supply of interdental brushes and received standardized instructions for their use. After collecting clinical indices at baseline (T0), six evaluation time points (T1-T6) were scheduled at 30-day intervals. At each time point, the following clinical parameters were recorded: * Full Mouth Plaque Score (FMPS) * Interdental Plaque Index * Full Mouth Bleeding Score (FMBS) * Papillary Bleeding Index Measurements were performed using a standardized millimeter periodontal probe (PCP UNC 15) and a plaque disclosing agent. At T3 (90 days), a crossover of the interdental devices between the two groups was performed: patients in Group 1 replaced the rubber interdental brush with the bristle device and vice versa. Subsequent clinical assessments were conducted using the same methods until the end of the study (T6). During each follow-up visit, a clinical reassessment was performed, including removal of any residual plaque using air polishing if necessary. At the end of the study (T6), in addition to recording clinical indices and final photographic documentation, participants completed a 17-item questionnaire designed to assess device acceptability, frequency and method of use, and knowledge of interdental devices. All collected data were recorded digitally and processed for descriptive and comparative statistical analyses between the two treatments.
Interventions
DEVICEGroup 1: use of the rubber interdental brush (picks) at baseline for 3 months
Group 1: use of the rubber interdental brush (picks) at baseline for 3 months, followed by use of the traditional bristle interdental brush for an additional 3 months.
DEVICEGroup 2: use of the traditional bristle interdental brush at baseline for 3 months
Group 2: use of the traditional bristle interdental brush at baseline for 3 months, followed by use of the rubber interdental brush for an additional 3 months
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 50 years * Interdental spaces suitable for the use of interdental brushes
Exclusion criteria
* Age below 18 or above 50 years * Presence of periodontitis * Presence of generalized diastemas * Presence of removable prostheses or orthodontic appliances * Presence of tremors or reduced mobility of the upper limbs; adequate oculomotor coordination required * Type 1 or type 2 diabetes * Immunodeficiency or immunocompromised conditions (e.g., HIV infection) * Pregnancy or breastfeeding * Hormonal therapy * Current pharmacological therapy with drugs known to cause gingival hyperplasia, such as phenytoin, cyclosporine, and calcium channel blockers * Psychiatric disorders * Heavy smoking (\>10 cigarettes/day) * Alcohol or drug abuse * Xerostomia * Patients with fixed dental implants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Full mouth bleeding score | From baseline (T0) to the end of the study at 180 days, with follow-up assessments every 30 days (T1-T6). | 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. |
| Full mouth plaque score | From baseline (T0) to the end of the study at 180 days, with follow-up assessments every 30 days (T1-T6). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | At 24 weeks after the start of the study | Patient satisfaction, assessed using a structured questionnaire evaluating satisfation with the picks or bristle interdental brush. Mixed scale including categorical preferences (picks vs. rubber) and dichotomous responses (Yes/No) for satisfaction items. 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