"Association of Peri-implantitis and Maxillary Sinusitis: a Case-control Study".
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ClinicalTrials.gov Identifier: NCT05924711 |
Recruitment Status :
Recruiting
First Posted : June 29, 2023
Last Update Posted : June 29, 2023
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Condition or disease | Intervention/treatment |
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Peri-Implantitis Sinusitis Sinusitis, Acute Sinusitis, Chronic Implant Infection Dental Implant Failure Nos | Other: Retrospective analysis of demographic and radiographic data previously obtained from the patient. |
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Study Type : | Observational |
Estimated Enrollment : | 40 participants |
Observational Model: | Case-Control |
Time Perspective: | Retrospective |
Official Title: | "Association Between the Treatment of Peri-implantitis and the Resolution of Maxillary Sinusitis: a Case-control Study". |
Actual Study Start Date : | June 6, 2023 |
Estimated Primary Completion Date : | July 5, 2023 |
Estimated Study Completion Date : | July 15, 2023 |
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Group/Cohort | Intervention/treatment |
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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.
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Other: Retrospective analysis of demographic and radiographic data previously obtained from the patient.
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. |
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.
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Other: Retrospective analysis of demographic and radiographic data previously obtained from the patient.
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. |
- Sinus membrane thickening changes after peri-implantitis treatment [ Time Frame: 6 months ]Sagital and coronal linear measurements of membrane thickening
- Severity of peri-implantitis in implants with maxillary sinusitis [ Time Frame: 1 month ]Linear measurements at 4 implant sites measured on the available CT scans of the patients
- Volume dimensional changes of the sinus membrane [ Time Frame: 1 month ]Total membrane occupancy inside the sinus and amount of sinus free of occupation
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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Men and women between 18-80 years of age |
Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05924711
Contact: Marta Monzo | 932 54 18 00 | secretariaodonto@uic.es |
Spain | |
Universitat Internacional de Catalunya (UIC) | Not yet recruiting |
Sant Cugat Del Vallès, Barcelona, Spain, 08195 | |
Contact: ramon pons, DDS 0034 619688364 ramonponsdds@gmail.com | |
Contact: Cristina Valles, PhD +34 93 504 20 00 cristinavallveg@uic.es | |
Ramon Pons | Recruiting |
Barcelona, Spain, 08017 | |
Contact: ramon pons, dds 619688364 ramonponsdds@gmail.com |
Study Chair: | Jose Nart, PhD | UIC |
Responsible Party: | Ramón Pons Calabuig, Principal investigator, Clinical Professor, Universitat Internacional de Catalunya |
ClinicalTrials.gov Identifier: | NCT05924711 |
Other Study ID Numbers: |
PER-ECL-2023-02 |
First Posted: | June 29, 2023 Key Record Dates |
Last Update Posted: | June 29, 2023 |
Last Verified: | June 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Data collected from patients may only be processed by the research team of this study and will not be shared with other researchers. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Sinusitis Maxillary Sinusitis Peri-Implantitis Respiratory Tract Infections Infections Paranasal Sinus Diseases |
Nose Diseases Respiratory Tract Diseases Otorhinolaryngologic Diseases Periodontal Diseases Mouth Diseases Stomatognathic Diseases |