Evaluation of the Marginal Integrity of Recent Bulk Fill Flowable Composite vs Glass Ionomer for Carious Cervical Restorations: RCCT

Dental Caries Class v Clinical Trial

Official title:

Evaluation of the Marginal Integrity of Recent Bulk Fill Flowable Composite vs Glass Ionomer for Carious Cervical Restorations: Randomized Controlled Clinical Trail

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04053530
• Other study ID #: oper 5215
• Status: Completed
• Phase: N/A
• Start date: August 4, 2019
• Est. completion date: October 15, 2020

Study information

• Verified date: January 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will be conducted to assess the marginal integrity of different types of restorations (ketac ™ N100 - ketac™ Universal and bulk fill flowable composite) in class v restoration using USPHS criteria.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: October 15, 2020
• Est. primary completion date: August 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Presence of at least one carious buccal cervical lesion.

2. The absence of tooth mobility.

3. Presence of contact with opposite teeth without any abnormal occlusion stress for the selected teeth.

4. Accessible isolation and observable and easily accessible gingival margins during tooth restoration.

Exclusion Criteria:

1. Patients with poor oral hygiene.

2. The presence of any para functional habit.

3. Abnormal occlusion.

4. Any regurgitation problem.

5. Subjects with compromised medical history.

6. Pulpitis, non-vital or endodontically treated teeth.

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries Class v

Intervention

Other:
• restorative materials
glass ionomer and bulk fill flowable composite

Locations

Country	Name	City	State
Egypt	Cairo university	Cairo
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	is marginal integrity of restoration.	Primary outcome is marginal integrity of restoration. It will be assessed by USPHS; score will be recorded according to USPHS criteria (Nassar et al., 2014).; 1. MARGINAL INTEGRITY; Alpha (A) Visual inspection and explorer The explorer does not catch when drawn across the surface of the restoration toward the tooth, or, if the explorer does not catch, there is no visible crevice along the periphery of the restoration.; Bravo (B) Visual inspection and explorer The explorer catches and there is visible evidence of a crevice, which the explorer penetrates, indicating that the edge of the restoration does not adapt closely to the tooth structure. The dentin and/or the base is not exposed, and the restoration is not mobile.; Charlie (C) Explorer The explorer penetrates crevice defect extended to the dentino-enamel junction.; Delta (D) Mobile, fractured or missing restoration in a part or total	12 months