Efficacy of Devices in Maintaining Oral Health and Managing Periodontal and Interproximal Tissues

Clinical Efficacy of Various Devices in Maintaining Oral Health and Managing Periodontal Tissues and Interproximal Spaces During Home Oral Hygiene Procedures

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Gingivitis; Oral Health; Gum Disease
• Intervention / Treatment: Device: Group 1: use of the rubber interdental brush (picks) at baseline for 3 months; Device: Group 2: use of the traditional bristle interdental brush at baseline for 3 months

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • rm
    • Roma, rm, Italy, 00161
      • Fabrizio Guerra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Group 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.
Experimental: 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	Device: Group 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Full mouth bleeding score	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.	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	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.	From baseline (T0) to the end of the study at 180 days, with follow-up assessments every 30 days (T1-T6).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	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.	At 24 weeks after the start of the study

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Publications and helpful links

General Publications

• Worthington HV, MacDonald L, Poklepovic Pericic T, Sambunjak D, Johnson TM, Imai P, Clarkson JE. Home use of interdental cleaning devices, in addition to toothbrushing, for preventing and controlling periodontal diseases and dental caries. Cochrane Database Syst Rev. 2019 Apr 10;4(4):CD012018. doi: 10.1002/14651858.CD012018.pub2.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): November 1, 2025
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Oral health; Gingivitis; Gum disease; Full mouth bleeding score; Full mouth plaque score
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Infections; Gingivitis; Gingival Diseases
• Other Study ID Numbers: 206/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No