Comparative Clinical Evaluation Between a Novel Self Adhesive and Conventional Bulk-fill Composites

Class II Dental Caries Clinical Trial

Official title:

Comparative Clinical Evaluation Between a Novel Self Adhesive and Conventional Bulk-fill Composites (a Randomized Controlled Clinical Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06120868
• Other study ID #: 7/2022
• Status: Completed
• Phase: N/A
• Start date: July 10, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: November 2023
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aimed to evaluate the clinical performance of a novel, tooth-colored, self-adhesive bulk-fill restorative, and a conventional bulk-fill composite, for restoring class II cavities.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Patients in need of restorative treatment on at least two class II Cavities in premolars or molars.
• Presence of proximal caries in digital x-ray with code 2 to 4 according to the radiographic International Caries Detection and Assessment System (ICDAS I).
• Presence of proximal caries in initial or moderate stage according to the International Caries Classification and Management System (ICCMS™).
• Only posterior teeth with class II cavities that have antagonistic contact and at least one proximal contact.
• Absence of parafunctional habits.
• Good general health

Exclusion Criteria:

• Serious medical disorders
• Clinical signs of bruxism, traumatic malocclusion
• Pregnant or breast feeding at the time of restoration placement
• Intolerance or allergy toward the applied restorative materials

Related Conditions & MeSH terms

• Class II Dental Caries
• Dental Caries

Intervention

Other:
• Surefil one®
For Surefil one® restorations, the capsule will be activated by pressing it against a stable surface, then mixed in a capsule mixer for 10 s. The capsule tip will be inserted into the proximal box, and the material is extruded as the tip is gradually moved in a coronal direction, ensuring that the material adapts to the cavity bottom and walls.
• Filtek One
Scotchbond™ Universal (SBU) will be used as an adhesive system in self-etch mode for FiltekTM One restoration. SBU will be applied actively for 20 seconds with a disposable brush tip, air-dried gently for 5 seconds to create a consistent bond thickness, then light-cured for 10 seconds. The FiltekTM One will be packed in increments up to 4 mm thick. A second layer of FiltekTM One will be applied on top of the first 4-mm layer if 4 mm is not adequate to properly restore the tooth. Each increment will be light cured for 20 seconds.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Nourhan M.Aly

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical success of the restoration	Clinical success of the restoration will be ranked according to the FDI Clinical Criteria which consider aesthetic, functional, and biological characteristics. The clinical assessment of the investigation criteria will be done by means of a five-score scale. FDI criteria scores 1, 2, and 3 are considered clinically excellent, good, and satisfactory. Score 4 indicates that the restoration is clinically unsatisfactory but repairable, however score 5 indicates that the restoration is clinically poor/failure and should be replaced.	up to 12 months