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Effect of Hygiene Devices on the healing of Inflammation around dental implants

Effect of Hygiene Devices on the healing of Peri-implant Mucositis lesions: a parallel randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-53643h8
Enrollment
Unknown
Registered
2022-09-26
Start date
2022-10-10
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Mucositis

Interventions

The present study will be randomized controlled and triple-blind. The study will last 4 weeks and will be divided into 2 phases: Phase 1: Self-administered mechanical cleaning. Day 0: Personalized Ora
Group 2 Interdental brush (Curaprox CPS prime® or Curaprox CPS Perio®), n=25. The choice of the appropriate interdental brush dimension will be performed using the IAP (Interdental Access Probing Cura
E06.761.726.794

Sponsors

Universidade Estadual de Maringá
Lead Sponsor
Universidade Estadual de Maringá
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age greater than or equal to eighteen years; Implants in function for more than a year; Diagnosis of peri-implant mucositis, defined as: Presence of visual signs of peri-implant inflammation combined with profuse bleeding on probing (line or drop) and/or suppuration at two or more sites, probing depths of four to five mm and no detectable bone loss

Exclusion criteria

Exclusion criteria: Absence of adjacent teeth; No contact point with adjacent teeth; Implants diagnosed with peri-implantitis; Patients in which the Curaprox IAP Probe cannot be used due to lack of space; Full-arch or removable implant-supported rehabilitation; Fixed implant-supported rehabilitation (multiple prosthesis); Implants with inadequate hygiene access or marginal misfit; Individuals with limited manual dexterity, making self-administered implant hygiene impossible; Presence of active periodontal disease; Heavy smokers; Patients with transmissible diseases or critical medical conditions such as, but not limited to: uncontrolled diabetes, AIDS, bone disease and rheumatic fever; Conditions requiring prophylactic antibiotic coverage prior to dental treatment; Pregnancy or breastfeed; Any known allergies to the components of the supplied products

Design outcomes

Primary

MeasureTime frame
Expected to find reduction of inflammation, evaluated by the probing method, verifying the absence of bleeding.

Secondary

MeasureTime frame
Expected to find reduction in the plaque accumulation, measured by the plaque index, checking values lower than 20%.;Expected to find narrower peri-implant pockets, evaluated in mm with the aid of a periodontal probe, checking smaller values in the probing. ;Expected to find high patient satisfaction, observed in the questionnaires, checking for positive responses.

Countries

Brazil

Contacts

Public ContactUniversidade de Maringá

Universidade Estadual de Maringá

ra114539@uem.br+55 (44) 999597622

Outcome results

None listed

Source: REBEC (via WHO ICTRP)