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NCT Number: NCT07520994

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fabrizio Guerra

Roma, rm, 00161, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group 1: use of the rubber interdental brush (picks) at baseline for 3 months

Device

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.

Group 2: use of the traditional bristle interdental brush at baseline for 3 months

Device

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

Primary outcomes

  1. 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.

  2. 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

  1. Patient satisfaction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Apr 9, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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