Skip to content

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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06875544
Acronym
Randomized
Enrollment
50
Registered
2025-03-13
Start date
2025-03-31
Completion date
2026-04-30
Last updated
2025-03-13

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

Conditions

Deep Margin Elevation, Dental, DME

Keywords

deep margin elevation

Brief summary

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.

Interventions

OTHERBeautifil F00

Beautifil F00 is bioactive giomer resin composite.

OTHERG-aenial Universal Injectable Flowable Composite

Nanohybrid resin composite is a type of restorative material that features nano-sized fillers as a main component

Sponsors

Future University in Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

1. Adult Patient (20-50 years old) 2. Good oral hygiene (plaque index 0 or 1) 3. Patient approval 4. Absence of parafunctional habits and/or bruxism 5. No endodontic treatment 6. No abscess 7. No partial or fixed denture

Exclusion criteria

1. Patients with known allergic or adverse reaction to the tested materials. 2. Bad oral hygiene 3. Systematic disease that may affect participation. 4. Xerostomic patients. 5. Patients with active periodontal disease. 6. Heavy smokers (those who smoke greater than or equal to 25 or more cigarettes a day) 7. Orthodontic treatment patient

Design outcomes

Primary

MeasureTime frameDescription
Recurrent cariesT (Time): T1: 1 week hours Baseline T2: 6 Months T3: 12 Months* 0: no evidence of caries continuous along the margin * 1: caries evident continuous with the margin of restoration

Secondary

MeasureTime frameDescription
1. Post-operative sensitivity. 2. Fracture of Restoration. 3. Bleeding on probingT (Time): T1: 1 week hours Baseline T2: 6 Months T3: 12 Months1. 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

Contacts

Primary ContactSherif Gamal Hamza, BDS
sheriefhamza2023@gmail.com+201060086406

Outcome results

None listed

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