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Access to Hygiene in Patients With Dental Implants Using Two Toothbrushes

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07724054
Enrollment
16
Registered
2026-07-23
Start date
2024-05-18
Completion date
2026-06-10
Last updated
2026-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peri Implant Mucositis, Plaque Removal

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.

Interventions

OTHERPlaque removal

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

Sponsors

Octavi Camps-Font
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Changes in the number of plaque-stained surfacesInmediately after the intervention

Secondary

MeasureTime frameDescription
Satisfaction questionnaire scoresInmediately after the interventionSeveral 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"
Absolute and relative counts of Porphyromonas Gingivalis and Fusobacterium NucleatumWhen the microbiological samples were analyzed
Total bacterial load quantified using universal 16S rDNA primersWhen microbial samples were analyzed

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 24, 2026