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OpenTrials
Completed

NCT Number: NCT07724054

Access to Hygiene in Patients With Dental Implants Using Two Toothbrushes

Peri-implant mucositis is a reversible inflammatory condition primarily caused by biofilm accumulation around dental implants. Effective plaque control is essential for disease resolution; however, the influence of toothbrush bristle design on plaque removal around implant-supported prostheses remains unclear. Polybutylene terephthalate (PBT) tapered-end bristles are more flexible than conventional medium-textured bristles and may improve access to peri-implant areas while increasing patient comfort. This study aims to compare the effectiveness of a PBT tapered-end toothbrush and a medium-textured toothbrush in plaque removal, peri-implant bacterial load reduction, and patient-reported outcomes in individuals with peri-implant mucositis. Each participant will use both toothbrushes in a randomized sequence separated by a six-week washout period. Visible plaque will be disclosed and quantified using standardized photographic analysis based on the Rustogi Modified Navy Plaque Index. Absolute and relative peri-implant bacterial loads of Porphyromonas gingivalis and Fusobacterium nucleatum, together with total bacterial load, will be quantified by quantitative polymerase chain reaction. Patient satisfaction, including perceived discomfort, comfort, ease of handling and intention to use, will be assessed using visual analogue scales.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Odontològic Universitat de Barcelona

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults diagnosed with peri-implant mucositis according to the 2017 World Workshop Classification.
  • Presence of a screw-retained implant-supported prosthesis comprising one to three crowns.
  • Attendance at the Implant Maintenance Unit during the recruitment period.

Exclusion criteria

  • Use of systemic antibiotics or antiseptic mouthrinses within the previous month.
  • Diagnosis of peri-implant health or peri-implantitis.
  • Special healthcare needs, mobility impairment, or cognitive/psychiatric disorders preventing adequate oral hygiene.

Treatment and study plan

Plaque removal

Other

Plaque removal with a Polybutylene terephthalate (PBT) tapered-end toothbrush

Primary outcomes

  1. Changes in the number of plaque-stained surfaces

    Time frame: Inmediately after the intervention

Secondary outcomes

  1. Satisfaction questionnaire scores

    Time frame: Inmediately after the intervention

    Several visual analogue scales (VAS) going from 0 to 10 points will be handled, being 10 the highest score, regarding "Discomfort", "Ease of use" and "Comfort"

  2. Absolute and relative counts of Porphyromonas Gingivalis and Fusobacterium Nucleatum

    Time frame: When the microbiological samples were analyzed

  3. Total bacterial load quantified using universal 16S rDNA primers

    Time frame: When microbial samples were analyzed

Sponsors and collaborators

Lead sponsor

Octavi Camps-Font

Other

Registry information

Official study title

Oral Hygiene Access in Patients With Dental Implants Using Two Toothbrushes: A Randomized Crossover Clinical Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2026
Registry last updated
Jul 23, 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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