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Incidence of Peri-implant Mucositis in Patients With Treated Periodontitis

ConditionPeri-implant Mucositis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversidad Complutense de Madrid

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients with untreated periodontitis.

Totally edentulous patients.

Patients with peri-implant diseases.

Pregnant or in lactating-period patients.

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Supportive periodontal and periimplant care

    Other intervention

    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

Treatment groups

277 Participants
are divided into 1 treatment group
Group A: One1 intervention

Trial outcomes

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.

Time frame
12 months

Secondary outcomes

1

Affiliation data

Age, Sex

Time frame
Baseline
2

previous medical history

systemic diseases, medication, allergies

Time frame
Baseline
3

smoking habit

ex-smoker/smoker/non-smoker

Time frame
Baseline
4

Other general data

sports habit, educational level, alcohol and coffee consumption, type of diet.

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad Complutense de Madrid

Lead sponsor

Sociedad Española de Periodoncia (SEPA)

Collaborator

Dentaid SL

Collaborator

Source ClinicalTrials.gov
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