"Association of Peri-implantitis and Maxillary Sinusitis: a Case-control Study".

NCT05924711 | Unknown DMC

• 1 other identifier: PER-ECL-2023-02
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

Scientific evidence regarding the influence of peri-implantitis on Schneider's membrane thickening is scarce and limited. Similarly, to date, there is no literature documenting the resolution of implant-associated maxillary sinusitis with peri-implantitis after treatment of peri-implantitis or removal of the implant. Therefore, the aim of this case-control study is to investigate the association between peri-implantitis and maxillary sinusitis. On the other hand, the changes that occur at the level of the maxillary sinus membrane after treatment of peri-implantitis or after implant explantation will be evaluated.

Conditions

Peri-Implantitis; Sinusitis; Sinusitis, Acute; Sinusitis, Chronic; Implant Infection; Dental Implant Failure Nos

Outcome Measures

Primary Outcomes (1)

• Sinus membrane thickening changes after peri-implantitis treatment

  Sagital and coronal linear measurements of membrane thickening

  6 months

Secondary Outcomes (2)

• Severity of peri-implantitis in implants with maxillary sinusitis

  1 month

• Volume dimensional changes of the sinus membrane

  1 month

Study Arms (2)

Case group

The case group will consist of 20 patients who will have implants diagnosed with peri-implantitis, according to the 2017 World Workshop Classification case definition.

Other: Retrospective analysis of demographic and radiographic data previously obtained from the patient.

Control group

The control group will include 20 subjects who will have implants with peri-implant health according to the 2017 World Workshop Classification case definition.

Other: Retrospective analysis of demographic and radiographic data previously obtained from the patient.

Interventions

Retrospective analysis of demographic and radiographic data previously obtained from the patient. OTHER

The patient's demographic data obtained previously by anamnesis and clinical examination will be retrospectively analyzsed. On the other hand, a radiographic evaluation including analysis of the implants, adjacent teeth and maxillary sinuses/sinus membranes shall be performed using computer software.

Case group; Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Men and women between 18-80 years of age
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients included in the study signed the corresponding informed consent forms for each of the treatments received, as well as for the use of their demographic and radiographic data for scientific purposes. The subjects recruited will be edentulous (partial/total) patients who previously had implants placed in the posterior region of the maxilla for oral rehabilitation. The case group will consist of 20 patients who will have implants diagnosed with peri-implantitis while in the control group the 20 subjects included will have implants with peri-implant health.

You may qualify if:

• Men and women between 18-80 years of age
• Patients with implants in the posterior sector of the upper jaw
• Dental implant carriers with a follow-up of more than 5 years
• Patients who have undergone a CT scan for the evaluation of these implants or for other reasons

You may not qualify if:

• Patients with uncontrolled systemic disease
• Pregnant or lactating patients
• Heavy smokers (HS)
• Patients with uncontrolled or active periodontal disease in need of periodontal treatment
• Patients with zygomatic or pterygoid implants
• Patients taking medications known to modify bone metabolism or who have degenerative bone disease (hyperparathyroidism, osteoporosis), vitamin D, patients who have taken antibiotics, NSAIDs or corticosteroids for more than two weeks in the last 3 months prior to the examination.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (2)

Universitat Internacional de Catalunya (UIC)

Sant Cugat del Vallès, Barcelona, 08195, Spain

NOT YET RECRUITING

Ramon Pons

Barcelona, 08017, Spain

RECRUITING

MeSH Terms

Conditions

Peri-Implantitis; Sinusitis; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Jose Nart, PhD

  UIC

  STUDY CHAIR

Central Study Contacts

Marta Monzo

CONTACT

932 54 18 00; secretariaodonto@uic.es

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Clinical Professor

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 29, 2023
• Study Start: June 6, 2023
• Primary Completion: July 5, 2023
• Study Completion: July 15, 2023
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)