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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04677023
Other study ID # 88960
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date February 1, 2022

Study information

Verified date December 2020
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In patients with compound posterior proximal cavities, will the use of organically modified ceramic resin composite restorative material have similar clinical performance to conventional bulk fill resin composite, evaluation of restorations will be done at baseline,six and twelve months using World Dental Federation FDI criteria.


Description:

The study will be conducted in the clinic of Conservative Dentistry Department, Faculty of Dentistry, Cairo University; the operator in charge Safinaz Hussien ,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 intra-oral 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 (Mepecaine-L, 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; FuturabondU(Voco, Germany) will be applied according to the following instructions recommended by the manufacturer: Futurabond M+ will be applied to prepared tooth structure and cured for 20 seconds using Elipar™ S10 LED curing light (3M ESPE, St Paul, MN, USA) with light intensity of 1200 mW/cm2. The prepared cavities will be restored with Admira fusion X--tra® bulk (VOCO, Cuxhaven in layers that are a maximum of 4 mm thick then cured for 20 seconds using usingElipar™ S10 LED curing light (3M ESPE, St Paul, MN, USA) with light intensity of 1200 mW/cm2. and for the control group cavities will be restored with GrandioSO x-tra(VOCO, Cuxhaven) in layers that are a maximum of 4 mm thick then cured for 20 seconds using usingElipar™ S10 LED curing light (3M ESPE, St Paul, MN, USA) with light intensity of 1200 mW/cm2.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 22
Est. completion date February 1, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Patients aging =18 years. - Patients with a high level of oral hygiene. - Patients having at least 1or 2 posterior teeth in occlusion. - Patients with good likelihood of recall availability. Tooth inclusion: - Permanent premolars or molars. - Moderate to deep compound class II cavities. - Primary carious lesions. - Vital with positive reaction to cold thermal stimulus. - Well-formed and fully-erupted in normal functional occlusion with natural antagonist and adjacent teeth. Exclusion Criteria: - Participants with general/systemic illness. - Pregnant or lactating females. - Concomitant participation in another research study. - Inability to comply with study procedures. - Heavy bruxism habits. - Last experience with allergic reactions against any components of the used materials. - Patients receiving orthodontic treatment. Tooth exclusion: - Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure. - Non-vital teeth. - Secondary carious lesions.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
GrandioSO x-tra® bulk
The prepared cavities will be restored with GrandioSO X-tra (VOCO, Cuxhaven, Germany) in layers that are a maximum of 4 mm thick then cured for 20 seconds using using Elipar™? S10 LED curing light (3M ESPE, St Paul, MN, USA) with light intensity of 1200 mW/cm2.
Admira fusion X--tra® bulk
he prepared cavities will be restored with Admira fusion X-tra®? bulk (VOCO, Cuxhaven, Germany) in layers that are a maximum of 4 mm thick then cured for 20 seconds using usingElipar™? S10 LED curing light (3M ESPE, St Paul, MN, USA) with light intensity of 1200 mW/cm2.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Other secondary caries Biological properties: visually inspected and evaluated using FDI probe and then classified accordingly
Clinically excellent / very good no caries
Clinically good small & localized
Clinically sufficient /satisfactory large area of demineralization
Clinically unsatisfactory (but reparable) caries with cavitation
Clinically poor (replacement necessary) Deep caries or exposed dentine
24 months
Primary Fracture Fracture of material visually inspected and evaluated using FDI probe and then classified accordingly
clinically excellent/very good: No fractures /cracks.
Clinically good: Small hairline crack.
Clinically sufficient /satisfactory(minor shortcomings, no unacceptable effects but not adjustable w/or damage to the tooth):Two or more or larger hairline cracks and/or material chipfracture no affecting the marginal integrity or approximal contact.
Clinically unsatisfactory /(but reparable):Material chip fractures which damage marginal quality or Bulk fractures with partial loss(less than half of the restoration). ditching or marginal fractures.
Clinically poor (replacement necessary): (Partial or complete) loss of restoration or multiple fractures.
24 months
Secondary color match Esthetic visually inspected and evaluated using FDI probe and then classified
clinically excellent/very good Luster comparable to enamel,& , no difference in shade
Clinically good Slightly dull, & minor shade deviation
Clinically sufficient /satisfactory. Dull surface & distinct shade deviation
Clinically unsatisfactory /(but reparable) Rough surface, & localized shade deviation that can be repaired
Clinically poor (replacement necessary): Very rough & un acceptable shade need replacement
24 months
See also
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