Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04738604 |
| Other study ID # |
91120 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2022 |
| Est. completion date |
February 1, 2023 |
Study information
| Verified date |
August 2021 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
in patients with Class I Cavities, will the use of Zenit Nano Ceramic Composite restorations
have similar clinical performance to conventional Ceram-X Nano Ceramic Composite
restorations, evaluation of restorations will be done at baseline, six, and twelve months
using Modified USPHS Ryge criteria.
Description:
The study will be conducted in the clinic of Conservative Dentistry Department, Faculty of
Dentistry, Cairo University; the operator in charge samah mohamed bahig, The subjects
fulfilling the eligibility criteria of the trial will be selected from the regular attendees
at the clinic of Conservative Dentistry Department, Faculty of Dentistry, Cairo University.
Patient examination will be done including medical history, dental history, extra-oral
examination and intraoral examination. A periapical radiograph will be taken prior to
restorative procedures to assess the degree of approximation of caries to pulp, intactness of
lamina dura and/or presence of any periapical radiolucency to exclude the case. The field of
operation will be isolated with the application of a rubber dam if possible. Otherwise,
cotton rolls and the saliva ejector will be used for moisture control. For cavity
preparation, local anesthetic (MepecaineL, Alexandria Company, Egypt) solution will be
administrated to control patient discomfort during the procedure. The cavities will be
prepared by using cylindrical #314 (Komet®, Germany) in a high speed handpiece (Sirona,
Germany) rotating at high speed with copious coolant. Remaining soft caries
-if present- will be removed using sharp excavator (Maillefer, Dentsuply, Switzerland).After
the cavity preparation is finished, it will be thoroughly air-water cleaned. The bonding
system; the Prime and Bond universal adhesive (Dentsply De Trey GmbH, Konstanz, Germany) will
be applied according to the following instructions recommended by the manufacturer and rubbed
for 20 seconds then blown with a gentle air blow for 5 seconds to evaporate the solvent and
then light curing for 10 seconds using LED light curing unit (>700 mW/cm2).The prepared
cavities will be restored with Zenit Nano Ceramic Composite (PRESIDENT DENTAL, GmbH, Munich,
Germany) will be applied with incremental placement technique (maximum: 2-mm layer).
Increments will be light curing for 40 seconds according to manufacturer's instructions. and
for the control group cavities will be restored withCeram•X (Dentsply De Trey GmbH, Konstanz,
Germany) with incremental placement technique (maximum: 2-mm layer). Increments will be light
cured for 20 seconds according to manufacturer's instructions.
