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Not yet recruitingNCT06946134Updated Apr 27, 2025

18-Month Clinical Evaluation of Self-Adhesive Flowable Giomer Compared to Conventional Flowable Giomer in Carious Cervical Lesions: A Randomized Clinical Trial

An interventional study of FIT SA and Beautifil Flow Plus F00 in Cervical Caries, sponsored by Cairo University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-27.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

The material under investigation will offer the patient a high strength and high durability restoration with the advantage of having anti-bacterial properties.

Read the detailed description

There is no available evidence for assessing FIT SA restorative material in restoration of cervical lesions. Therefore, this study aims to provide valuable insights into the shear bond strength and clinical performance, in terms of the biological, mechanical and esthetic parameters, of FIT SA restorative material in restoration of cervical lesions.

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Conditions studied

  • Cervical Caries

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Keywords

  • Self-adhesive giomer
  • Bioactive
  • Randomized clinical trial.
  • USPHS criteria
  • Carious cervical lesion
  • Class V
  • Clinical performance
  • FIT SA
  • Beautifil Flow Plus
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In context

Root Caries

39 studies on the registry are indexed under Root Caries; 14 are open to participants now.

This study's planned enrollment of 34 is below the median of 62 across 35 interventional studies indexed under Root Caries.

Browse Root Caries studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Cervical carious lesions in anterior teeth and premolars
  2. Small to moderate class V carious lesion (ICDAS 3 \& 4).
  3. Vital upper or lower periodontally sound teeth with no signs of irreversible pulpitis.
  4. Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth

Exclusion criteria

Exclusion Criteria:

  1. Cervical carious lesions in molars.
  2. Deep carious defects (close to pulp, less than 1 mm distance).
  3. Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
  4. Non-vital teeth, Fractured or cracked teeth.
  5. Endodontically treated teeth.
  6. Periodontally affected teeth
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
34 participants (estimated)

Study arms

  • Active comparator
    Beautifil Flow Plus F00

    Conventional flowable giomer restorative material

    Other: Beautifil Flow Plus F00

  • Experimental
    FIT SA

    Self adhesive flowable giomer restorative material

    Other: FIT SA

Interventions

  • OtherFIT SA

    self-adhesive flowable giomer restorative material

  • OtherBeautifil Flow Plus F00

    Conventional flowable giomer restorative material

06

What researchers measure

Primary outcomes

  1. Clinical Performance

    Clinical Performance using Modified USPHS criteria

    Time frame: 18 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Related links

Individual participant data

Plan to share: Yes — There is no available evidence for assessing FIT SA restorative material in restoration of cervical lesions. Therefore, this study aims to provide valuable insights into the shear bond strength and clinical performance, in terms of the biological, mechanical and esthetic parameters, of FIT SA restorative material in restoration of cervical lesions

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06946134
Lead sponsor
Cairo University
Responsible party
Amera Nabel (master holder, Cairo University) — Principal investigator
First posted
Apr 27, 2025
Start date
Sep 2025 (estimated)
Primary completion
Feb 2027 (estimated)
Completion
Feb 2027 (estimated)
Last update
Apr 27, 2025

Study contacts

Amira Nabil El-Gaaly, PhD degree
Contact
amera.elgaaly@dentistry.cu.edu.eg
00201099872098

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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