- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT05140447
Temperature Change of the Pulpal Floor and Restoration With Preheated Resin Composite (A Randomized Clinical Trial)
clinical evaluation of the effect of preheating BIS-GMA free resin composite at different temperatures on temperature change of the pulpal floor and restorations and compare it with BIS-GMA containing resin composite.
Hypothesis: Could the preheated composite affect the temperature of the pulpal floor
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
-
Minya, Egypti, 61519
- Faculty of Dentistry - Minia University
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- Healthy men and women patients of 25-45 years.
- They should have a good oral hygiene level.
- Presence of at least two posterior class I or II carious lesions to be restored with two different composite resin restorations.
- All carious lesions in selected patients didn't close to the pulp in the preoperative radiograph.
- No preoperative pain.
- Normal occlusal contact with opposing teeth.
- No history of periodontal treatment, including periodontal surgery, in the past year.
- All patients had to sign a written consent before being included.
- A good likelihood of recall availability.
Exclusion Criteria:
- patient with severe periodontitis or severe erosion damage.
- patients with a compromised medical history or had received therapeutic irradiation to the head and neck region.
- If analgesics or antibiotics had administered by the patient during the past 12 hours preoperatively as it might alter their pain perception.
- patients reported bruxism or clenching.
- Greater than grade I mobility or pocket depth greater than 5mm.
- Non-restorable teeth or hopeless teeth.
- Immature teeth.
- Radiographic evidence of external or internal root resorption.
- Alcoholic and smoker patients.
- Pregnant or breastfeeding ladies.
- Patients who had physical disabilities, or who are unable to brush their teeth.
- Individuals who had sensitive teeth but with one of the following conditions was excluded from the study, teeth with large restoration, abutment of teeth of removable partial dentures, dental restorations, abutment of teeth of removable partial dentures, enamel cracks, leakage of fillings or other restorations teeth, dental pulp lesions, dental abscesses, pulpitis, and atypical facial pain.
- Patients who had non-carious lesions like attrition, erosion, abrasion or abfraction.
- Patients had participated in a clinical trial within 6 months before commencement of this trial.
- Patients unable to return for a recall appointment.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Muut
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
---|---|
Active Comparator: Admira 50º C
in this subgroup the patient's teeth was restored with Admira fusion extra resin composite preheated to 50º C
|
evaluate the effect of preheating BIS-GMA free resin composite at different temperatures on temperature change of the pulpal floor and restorations and compare it with BIS-GMA containing resin composite.
Muut nimet:
|
Active Comparator: Admira 70º C
in this subgroup the patient's teeth was restored with Admira fusion extra resin composite preheated to 70º C
|
evaluate the effect of preheating BIS-GMA free resin composite at different temperatures on temperature change of the pulpal floor and restorations and compare it with BIS-GMA containing resin composite.
Muut nimet:
|
Active Comparator: Viscalor 50º C
in this subgroup the patient's teeth was restored with Viscalor resin composite preheated to 50º C
|
evaluate the effect of preheating BIS-GMA free resin composite at different temperatures on temperature change of the pulpal floor and restorations and compare it with BIS-GMA containing resin composite.
Muut nimet:
|
Active Comparator: Viscalor 70º C
in this subgroup the patient's teeth was restored with Viscalor resin composite preheated to 70º C
|
evaluate the effect of preheating BIS-GMA free resin composite at different temperatures on temperature change of the pulpal floor and restorations and compare it with BIS-GMA containing resin composite.
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
pulpal floor temperature and restoration temperature
Aikaikkuna: one year
|
evaluation the effect of preheating BIS GMA free resin composite at different temperature on temperature change of pulpal floor and restoration and compare it with BIS GMA containing resin composite All readings were taken with the presence of a rubber dam and recorded in Celsius (°C). Five temperature readings were measured for each tooth; (C0): pulpal floor temperature before beginning the restorative procedure. (C1): pulpal floor temperature during placement of preheated composite. (C2): top composite surface after packing and before curing. (C3): pulpal floor temperature after curing of the preheated composite. (C4): top composite surface after curing. The pulpal floor and the restoration temperature of each tooth was measured by a K-type temperature Probe attached to portable mini type thermometer device |
one year
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
The effect of different preheating temperatures on restoration temperature and pulpal floor temperature
Aikaikkuna: one year
|
Five temperature readings were measured for each tooth; (C0): pulpal floor temperature before beginning the restorative procedure.
(C1): pulpal floor temperature during placement of preheated composite.
(C2): top composite surface after packing and before curing.
(C3): pulpal floor temperature after curing of the preheated composite.
(C4): top composite surface after curing.
The pulpal floor and the restoration temperature of each tooth was measured by a K-type temperature Probe attached to portable mini type thermometer device
|
one year
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
The difference in restoration and pulpal floor temperatures before and after curing of preheated resin composite
Aikaikkuna: one year
|
Five temperature readings were measured for each tooth; (C0): pulpal floor temperature before beginning the restorative procedure.
(C1): pulpal floor temperature during placement of preheated composite.
(C2): top composite surface after packing and before curing.
(C3): pulpal floor temperature after curing of the preheated composite.
(C4): top composite surface after curing.
The pulpal floor and the restoration temperature of each tooth was measured by a K-type temperature Probe attached to portable mini type thermometer device
|
one year
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojohtaja: Mona I Riad, Professor, Professor at Faculty of Dentistry Cairo University
- Opintojohtaja: Nermin A Mahmoud, Lecturer, Lecturer at Faculty of Dentistry Minia University
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muut tutkimustunnusnumerot
- 490
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .