NCT07520994

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 9, 2026

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

April 22, 2026

Status Verified

March 1, 2026

Enrollment Period

2.2 years

First QC Date

April 2, 2026

Last Update Submit

April 16, 2026

Conditions

GingivitisGum DiseaseOral Health

Keywords

GingivitisGum diseaseOral healthFull mouth bleeding scoreFull mouth plaque score

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Patient satisfaction

    At 24 weeks after the start of the study

Study Arms (2)

Group 1: picks interdental brush (T0), Bristle interdental brush (T3)

EXPERIMENTAL

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 2: Bristle interdental brush (T0), picks interdental brush (T3),

EXPERIMENTAL

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

Interventions

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

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

Group 2: Bristle interdental brush (T0), picks interdental brush (T3),
Group 1: use of the rubber interdental brush (picks) at baseline for 3 monthsDEVICE

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 1: picks interdental brush (T0), Bristle interdental brush (T3)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 50 years
  • Interdental spaces suitable for the use of interdental brushes

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fabrizio Guerra

Roma, rm, 00161, Italy

Location

Related Publications (1)

  • 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.

    PMID: 30968949BACKGROUND

MeSH Terms

Conditions

GingivitisGingival Diseases

Condition Hierarchy (Ancestors)

InfectionsPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, MD, pHd

Study Record Dates

First Submitted

April 2, 2026

First Posted

April 9, 2026

Study Start

September 1, 2023

Primary Completion

November 1, 2025

Study Completion

April 30, 2026

Last Updated

April 22, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)