Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04053530
Enrollment
63
Registered
2019-08-12
Start date
2019-08-04
Completion date
2020-10-15
Last updated
2021-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries Class v

Brief 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.

Interventions

glass ionomer and bulk fill flowable composite

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Data analysts, statistician and outcome assessor (A.O.) will be blinded after assignment to interventions while the operator will not due to the difference in restorative material presentation and its application protocol.

Intervention model description

3 parallel groups

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
is marginal integrity of restoration.12 monthsPrimary 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026