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Incidence of Peri-implant Mucositis in Patients With Treated Periodontitis

NCT ID: NCT05356806

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

277 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-10

Study Completion Date

2026-06-30

Brief Summary

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the objective of this study is to determine the incidence of peri-implant mucositis in patients with treated periodontitis and enrolled in periodontal maintenance and to evaluate the associated risk indicators. An analytical prospective observational study will be carried out, with an initial follow-up of 12 months.

Detailed Description

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Introduction: Peri-implant mucositis (PM) is an inflammatory disease induced by the accumulation of bacteria (biofilm) around dental implants, which can be modulated by individual characteristics of the patient, as well as by numerous factors related to a greater accumulation of biofilm in peri-implant tissues. Without correct regular maintenance, this entity can progress to peri-implantitis, a disease in which there is loss of bone supporting the implant. However, the strength of the association of the factors with the appearance of PM remains weak and incidence studies are limited due to their design and methodological inconsistencies. Therefore, the objective of this study is to determine the incidence of PM in patients with treated periodontitis and enrolled in periodontal maintenance and to evaluate the associated risk indicators.

Material and method: An analytical prospective observational study will be carried out, with an initial follow-up of 12 months. Patients with treated periodontitis and enrolled in periodontal maintenance will be selected, consecutively. They need to have implants placed in the Periodontics Specialist Clinic and are going to be rehabilitated at the UCM School of Dentistry. Peri-implant and periodontal clinical records, radiographic records, demographic variables, patient-based variables, and submucosal microbiological samples will be taken on the day of crown placement and after 6 and 12 months. The calculation of the sample size estimates the need to recruit 227 patients. The results will be analyzed using regression models.

Conditions

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Peri-implant Mucositis

Keywords

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peri-implant mucositis incidence biofilm periodontitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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One

Patients with treated periodontitis who have had dental implants placed at the Periodontics Specialist Clinic of the UCM School of Dentistry, and are going to be rehabilitated.

Supportive periodontal and periimplant care

Intervention Type OTHER

Periodontal and peri-implant maintenance therapy will be carried out at baseline, 3 and 6-month visit. This session will include the removal of biofilm and calculus on teeth and implants (except those that have just been restored) with an ultrasonic device using a plastic tip ( for implants. and a conventional metal tip ( for teeth. At the end, polishing will be done with a rubber cup

Subsequently, patients will be explained that they must continue with their usual oral hygiene technique on their teeth, using the same type of brush (which can be electric or manual), interproximal devices, toothpaste or mouthwash used to date. Finally, they will receive specific instructions for the supragingival biofilm control in the area of the new restoration and will be given interdental brushes that suit to the space

Interventions

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Supportive periodontal and periimplant care

Periodontal and peri-implant maintenance therapy will be carried out at baseline, 3 and 6-month visit. This session will include the removal of biofilm and calculus on teeth and implants (except those that have just been restored) with an ultrasonic device using a plastic tip ( for implants. and a conventional metal tip ( for teeth. At the end, polishing will be done with a rubber cup

Subsequently, patients will be explained that they must continue with their usual oral hygiene technique on their teeth, using the same type of brush (which can be electric or manual), interproximal devices, toothpaste or mouthwash used to date. Finally, they will receive specific instructions for the supragingival biofilm control in the area of the new restoration and will be given interdental brushes that suit to the space

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Over 18 years of age, able to comply with the protocol and comply with the established visits.
* Patients with treated periodontitis and enrolled in periodontal maintenance (last maintenance therapy received between 4 and 6 months maximum before inclusion in the study) (Chapple et al., 2018, Sanz et al., 2020).
* Patients with osseointegrated dental implants waiting for their prosthodontic rehabilitation (fixed prosthesis \[individual, partial or complete\], hybrid or overdenture).
* Physical or mental conditions that make it possible to perform appropiate oral hygiene

Exclusion Criteria

* Patients with untreated periodontitis.
* Totally edentulous patients.
* Patients with peri-implant diseases.
* Pregnant or in lactating-period patients.
* Patients undergoing treatment with medication that affects the periodontal/peri-implant status or the immune system (phenytoin, calcium antagonists, corticosteroids or anti-inflammatories).
* Patients who have taken antibiotics in the last month.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sociedad Española de Periodoncia (SEPA)

UNKNOWN

Sponsor Role collaborator

Dentaid SL

INDUSTRY

Sponsor Role collaborator

Universidad Complutense de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elena Figuero, Prof.

Role: PRINCIPAL_INVESTIGATOR

Etiology and Therapy of Periodontal and Periimplant Research Group (ETEP). Faculty of Dentistry. University Complutense of Madrid (UCM)

Locations

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Faculty of Dentistry, University Complutense of Madrid (UCM)

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Elena F Figuero, Prof.

Role: CONTACT

Phone: 0034913942186

Email: [email protected]

María Rioboo, Dr

Role: CONTACT

Email: [email protected]

Facility Contacts

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Elena Figuero, Prof.

Role: primary

Maria Rioboo, Dr.

Role: backup

Other Identifiers

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52-240521

Identifier Type: -

Identifier Source: org_study_id