Access to Hygiene in Patients With Dental Implants Using Two Toothbrushes

NCT07724054 | Completed

• 1 other identifier: 42/2024
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Plaque Removal; Peri Implant Mucositis

Outcome Measures

Primary Outcomes (1)

• Changes in the number of plaque-stained surfaces

  Inmediately after the intervention

Secondary Outcomes (3)

• Satisfaction questionnaire scores

  Inmediately after the intervention

• Absolute and relative counts of Porphyromonas Gingivalis and Fusobacterium Nucleatum

  When the microbiological samples were analyzed

• Total bacterial load quantified using universal 16S rDNA primers

  When microbial samples were analyzed

Study Arms (2)

Medium-textured toothbrush

ACTIVE COMPARATOR

Plaque removal with a medium-textured toothbrush

Other: Plaque removal

Polybutylene terephthalate (PBT) tapered-end toothbrush

EXPERIMENTAL

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

Other: Plaque removal

Interventions

Plaque removal OTHER

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

Medium-textured toothbrush; Polybutylene terephthalate (PBT) tapered-end toothbrush

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Octavi Camps-Font: lead

Study Sites (1)

Hospital Odontològic Universitat de Barcelona

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 23, 2026
• Study Start: May 18, 2024
• Primary Completion: May 20, 2026
• Study Completion: June 10, 2026
• Last Updated: July 23, 2026

Record last verified: 2026-06

Locations

ES (1)