Incidence of Peri-implant Mucositis in Patients With Treated Periodontitis

NCT05356806 | Recruiting

• 1 other identifier: 52-240521
• Study Type: observational
• Target: 277
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peri-implant Mucositis

Keywords

peri-implant mucositis; incidence; biofilm; periodontitis

Outcome Measures

Primary Outcomes (1)

• Incidence of peri-implant mucositis

  The risk of developing PM (patient with at least one implant who has bleeding on probing, with or without suppuration and without progressive radiographic bone loss) during a follow-up period of 12 months.

  12 months

Secondary Outcomes (50)

• Affiliation data

  Baseline

• previous medical history

  Baseline

• smoking habit

  Baseline

• Other general data

  Baseline

• Previous dental history

  Baseline

Study Arms (1)

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.

Other: Supportive periodontal and periimplant care

Interventions

Supportive periodontal and periimplant care 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

One

Eligibility Criteria

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

Study Population

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 in the same center

You may qualify if:

• Over 18 years of age, able to comply with the protocol and comply with the established visits.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Sociedad Española de Periodoncia (SEPA): collaborator
• Dentaid SL: collaborator

Study Sites (1)

Faculty of Dentistry, University Complutense of Madrid (UCM)

Madrid, 28040, Spain

RECRUITING

Biospecimen

Samples containing bacterial DNA

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Elena Figuero, Prof.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena F Figuero, Prof.

CONTACT

0034913942186; elfiguer@ucm.es

María Rioboo, Dr

CONTACT

mrioboo@ucm.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 2, 2022
• Study Start: January 10, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)