Clinical Performance of High Viscosity Bioactive Injectable Composite in Deep Marginal Elevation

ConditionsDME Dental Deep Margin Elevation

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age20-50

SponsorFuture University in Egypt

About this trial

Using a bioactive resin composite in subgingival Class II cavities can provide enhanced caries resistance by releasing multiple ions, including fluoride. This approach offers greater resistance to caries due to the incorporation of surface pre-reacted glass filler (S-PRG) technology (Imazato, Nakatsuka et al., 2023).

This type of composite may improve the outcomes of deep subgingival margin elevation, benefiting both restorative success and periodontal health.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adult Patient (20-50 years old)

Good oral hygiene (plaque index 0 or 1)

Patient approval

Absence of parafunctional habits and/or bruxism

Disqualifiers

Patients with known allergic or adverse reaction to the tested materials.

Bad oral hygiene

Systematic disease that may affect participation.

Xerostomic patients.

Trial design

Design model

Single group

Treatments tested in this trial

Beautifil F00
Other intervention
Beautifil F00 is bioactive giomer resin composite.
G-aenial Universal Injectable Flowable Composite
Other intervention
Nanohybrid resin composite is a type of restorative material that features nano-sized fillers as a main component

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: Bioactive injectable giomerActive comparator 1 intervention

Group B: Nanohybrid injectable compositeActive comparator 1 intervention

Trial outcomes

Primary outcomes

Recurrent caries

* 0: no evidence of caries continuous along the margin * 1: caries evident continuous with the margin of restoration

Time frame

T (Time): T1: 1 week hours Baseline T2: 6 Months T3: 12 Months

Secondary outcomes

1. Post-operative sensitivity. 2. Fracture of Restoration. 3. Bleeding on probing

1. Post-operative sensitivity. * 1: Absent * 2: Present 2. Fracture of Restoration. * 1: Restoration is intact and fully retained. * 2: Restoration is partially retained with some portion of the restoration still intact. * 3: Restoration is completely missing 3. Bleeding on probing * 0: Healthy gums * 1: Bleeding on probing 2:periodontal problem with bone loss

Time frame

T (Time): T1: 1 week hours Baseline T2: 6 Months T3: 12 Months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Future University in Egypt

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: