- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07633912
Local Factors in the Onset/Progression of Peri-implantitis: A Retrospective Study
With the increasing burden of peri-implantitis worldwide, interest in the management of this pathology has flourished. However, there is a lack of consensus in the search for a predictable therapy. Different therapeutic modalities have been advocated. Non-surgical therapy as a sole modality is often insufficient to resolve inflammation. Surgical interventions have demonstrated more favorable results. Among these, evidence supported the application of resective, reconstructive or combined approaches to limit progressive bone loss and achieve soft tissue health. However, to date, the most appropriate modality is unknown and the decision-making process derives from the understanding gained in the management of periodontitis.
A very relevant aspect of peri-implantitis is that the prevalence tends to be higher at the patient level than at the implant level. This indicates that it is a pathology in which there are localized factors that may contribute to the onset and/or perpetuation of the pathology. Some of the factors that have been demonstrated in the literature point to the characteristics of the peri-implant soft tissues, as well as the position of the dental implants. However, the role of each local factor in the predisposition or protection of peri-implant disease or health is still largely unknown. The objective of this study is therefore to evaluate, in partially edentulous patients with multiple implants, the localized factors associated with peri-implantitis.
Studieoversigt
Detaljeret beskrivelse
Variables to explore:
Patient-related variables:
- Periodontal health (health, pathology)
- Periodontal status classification (stage, grade)
- Smoker (S, NS, FS)
- Compliance (NC, C, CE)
- Age (y)
- Time since implants (y)
- Pathology (DM, CVD, OP, other)
- Medication
- Anticoagulant (y/n)
- Plaque control (<20%, >20%, >50%)
Clinical variables:
- Keratinized mucosa (narrow, wide, lack)
- Vestibule (Deep ≥4mm, shallow <4mm, lack)
- Number of implants supporting the prosthesis (n)
- Implant location in the fixed prosthesis (mesial, distal, medial)
- Interproximal access with a 0.5mm brush between implants (IP-i)
- Interproximal access with a 0.5mm brush between implants implant-tooth (IP-t)
- Prosthesis type (SC, FPD)
- Cemented or screw-retained (C, S)
- Ceramic to connection (Y/N)
- Prosthesis material (Zr, Cr-Co)
- Implant (NB, ST, TC, DT, BTI, other)
- Implant diameter (mm)
- Implant length (mm)
- Position (M, PM, A, a, pm, m)
Radiographic variables:
- Distance between implants (m-d)
- Distance to adjacent tooth (m-d)
- Occlusal deviation towards buccal-lingual (b-l)
- Apico-coronal position with respect to adjacent tooth (a-c) with respect to LAC
- Apico-coronal position with respect to adjacent implant (a-c) with respect to coronal
- Inclination (implant deviation º) (m-d), (b-l) and º
- Defect configuration (Monje et al. 2019)
- Implant type (BL, TL)
- Transmucosal abutment (Y, N, short <2mm, long ≥2mm)
- Inadequate implant-prosthesis connection (Ill-fitting)
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Badajoz, Spanien, 06011
- Centro de Implantologia Cirugia Oral y Maxilofacial
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Partially edentulous patients
- Peri-implantitis and non-peri-implantitis implants
- Readable x-ray and clinical signs of inflammation/health
Exclusion Criteria:
- Complete edentulous patients
- Inconsistent definition of peri-implantitis
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Peri-implantitis
Tidsramme: >12 months
|
Bone loss (≥3mm) occurring with clinical signs of inflammation
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>12 months
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studiestol: Alberto Monje Correa, DDS, MS, PhD, Cicom Monje
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 18002909(B)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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