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

F

Future University in Egypt

Status

Not yet enrolling

Conditions

Dental
Deep Margin Elevation
DME

Treatments

Other: G-aenial Universal Injectable Flowable Composite
Other: Beautifil F00

Study type

Interventional

Funder types

Other

Identifiers

NCT06875544
Deep margin Elevation

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

50 participants in 2 patient groups

Bioactive injectable giomer
Active Comparator group
Description:
Deep margin elevation and subsequent restoration will be done using bioactive giomer material
Treatment:
Other: Beautifil F00
Nanohybrid injectable composite
Active Comparator group
Treatment:
Other: G-aenial Universal Injectable Flowable Composite

Trial contacts and locations

0

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Central trial contact

Sherif Gamal Hamza, BDS

Data sourced from clinicaltrials.gov

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