Clinical Efficacy of Various Devices in Maintaining Oral Health and Managing Periodontal Tissues and Interproximal Spaces During Home Oral Hygiene Procedures
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Full mouth bleeding score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Group 1: picks interdental brush (T0), Bristle interdental brush (T3)
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.
Intervention: Group 1: use of the rubber interdental brush (picks) at baseline for 3 months (Device)
Group 2: Bristle interdental brush (T0), picks interdental brush (T3),
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
Intervention: Group 2: use of the traditional bristle interdental brush at baseline for 3 months (Device)
Outcomes
Primary Outcomes
Full mouth bleeding score
Time Frame: 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
Time Frame: 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 Outcomes
- Patient satisfaction(At 24 weeks after the start of the study)
Investigators
Fabrizio Guerra
Associate professor, MD, pHd
University of Roma La Sapienza