- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07688408
Short Implants in Unitary Implant-supported Rehabilitations in the Posterior Maxilla and Mandible: 5 Years of Follow-up
Short Implants (7 and 8 mm) in Unitary Implant-supported Rehabilitations in the Posterior Sector of the Maxilla and Mandible: 5 Years of Follow-up
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
3.3. Clinical examinations A single, trained and calibrated examiner will perform all clinical examinations. The examiner will be trained and calibrated before and during the study in order to achieve maximum reproducibility in measurements. The methodology to be used for intra-examiner calibration will be the one recommended by Araujo et al. 2003, in which the standard error of measurement for continuous periodontal clinical parameters (SP and CIN) is evaluated. For the other clinical variables, the mean level of agreement between the examiners will be determined and considered satisfactory when the value is greater than 90% (Kappa test).
Clinical measures
The following parameters will be recorded at six sites per implant using a periodontal probe North Carolina (Hu-Friedy, Chicago, IL, USA):
- Plate index (PI): 0 = absence of plaque; 1 = separate patches of plaque at the cervical margin; 2 = a thin, continuous band of plaque [up to 1 mm] at the cervical margin of the tooth; 3 = strip of plaque greater than 1 mm, but covering less than 1/3 of the tooth crown; 4 = plaque that covers at least 1/3 but less than 2/3 of the tooth's crown; 5 = plate covering 2/3 or more of the tooth's crown).
- Gingival index (GI): 0 = absence of inflammation; 1 = mild inflammation change in color and little change in texture; 2 = moderate inflammation - tempered glasses, redness, edema and hypertrophy; 3 = severe inflammation - marked redness and hyperplasia.
- Bleeding on probing (SS): 0 = absence; 1 = presence.
- Suppuration (Sup): 0 = absence; 1 = presence.
- Probing depth (PS): distance (mm) from the peri-implant mucosal margin to the most apical portion of the peri-implant pocket.
- Relative attachment level (NI): distance (mm) from the implant shoulder to the most apical portion of the peri-implant pocket.
- Keratinized tissue height (THA): vertical distance (mm) measured from the mucogingival line to the peri-implant margin in the center of the buccal face of the implant.
- Keratinized tissue thickness 1 (ETQ1): measured in the center of the buccal surface of the ridge, at the midpoint between the mucogingival line and the top of the ridge.
- Mesial and distal keratinized tissue thickness 2 (ETQ2M, ETQ2D): measured over the ridge (mesial and distal of the implant) when the crown can be removed.
- Evaluation of the biotype of peri-implant tissue (Rouk et al. 2009): thin or thick, according to the visualization of the periodontal probe through the peri-implant tissue.
Screw-retained implant crowns will be removed to observe clinical records, while cemented crowns will not be removed.
Radiographic measurements As a way of evaluating the stability of bone tissue, the interproximal level of the bone crest will be measured by means of periapical radiographs. After the radiographic takes, the radiographs will be scanned and the distance in millimeters from the interproximal bone crest to the base of the implant will be evaluated.
ISQ Stability Type 16 smartpegs will be inserted directly into the implants for ISQ evaluation Implant Stability Quotient) by means of an appropriate device (Osstell, Integration Diagnostics, Savadal, Sweden). For each series of measurements, the resonance analysis frequency unit (RFA - Resonance Frequency Analysis) will be used, observing that the ISQ varies between 1 and 100, and the measurements will be made 3 consecutive times to obtain the average.
3.4. Analysis Model
The primary outcome variable of the study will be variation in bone remodeling between the initial and final values. The radiographic parameter will be calculated for each face (mesial and distal) and then the average among the volunteers in each evaluation period will be calculated separately. The Wilcoxon Rank non-parametric paired test will be used to compare differences between baseline values and each assessment period. The significance level will be 5%.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní místa
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São Paulo
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Guarulhos, São Paulo, Brazílie, 073040
- Guarulhos University
-
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Individuals (> 21 years old), of both sexes, specifically rehabilitated with morse connection implants (Implacil De Bortoli, São Paulo, SP, Brazil) in the posterior region of the jaws for single-sided unsupported restorations, will be included in this study. Individuals will also need to have at least initial radiographic controls (immediately after implant placement) and 12 and 60 months of follow-up after implant placement. Individuals will be included in the population sample, with the following criteria observed: location, implant installation region, implant diameter, and adaptation.
Exclusion Criteria:
- Immediate implants will be excluded, individuals with clinical records who, throughout the study, do not have radiographs for evaluation and/or radiographs of poor quality that make radiographic measurements impossible; medical records with insufficient data, filled out inappropriately or that indicate doubt about the details of the procedure performed.
Studijní plán
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
The primary outcome variable of the study will be variation in bone remodeling between the initial and final values (measured in mm)
Časové okno: 60 months
|
Bone loss measured from the abutment-implant junction to the first visible bone to implant contact visible in a X-ray
|
60 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 95602126.9.0000.5506
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Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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