NCT06603116

Brief Summary

Assess the clinical performance of the bioactive Giomer restoration in class II cavities after one year using FDI criteria for assessment of dental restorations. Moreover, the surface roughness will be investigated in-vitro using profilometer

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2022

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2022

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

7 days

First QC Date

September 17, 2024

Last Update Submit

September 17, 2024

Conditions

Dental Restoration Failure

Keywords

Bioactive Giomer restorationNano hybrid composite

Outcome Measures

Primary Outcomes (1)

  • evaluation of restorations of class two cavities

    Measured used FDI criteria

    from one week to one year

Study Arms (2)

Bioactive Giomer restoration.

EXPERIMENTAL

material applied according to manufacturer instructions. BEAUTIFIL II LS applied directly into the cavity and create the shape desired in layers not exceeding 2 mm and light cured for 20 seconds

Other: treatment of class two cavities

Nano-hybrid Composite restoration.

ACTIVE COMPARATOR

applied to the cavity use the conventional incremental technique according to manufacturer instruction

Other: treatment of class two cavities

Interventions

treatment of class two cavitiesOTHER

restorations in class 2 cavities

Bioactive Giomer restoration.Nano-hybrid Composite restoration.

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Each patient should have at least two proximal carious lesions on both sides in the posterior teeth.
  • Adjacent and opposing natural teeth should be present.
  • Patient should be willing to return for follow-up examination and evaluation.

You may not qualify if:

  • Patient with poor oral hygiene and motivation.
  • Patient with unrealistic expectations.
  • Patients with disabilities, systemic diseases or severe medically compromised, bruxism, clenching or temporomandibular joint disorders and patients with allergy to any components of the materials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dental Medicine for Girls, Al-Azhar University, Egypt

Cairo, Egypt

Location

Study Officials

  • Maha Niazy, PHD

    Faculty of Dental Medicine for Girls, Al-Azhar University, Egypt

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer at operative department

Study Record Dates

First Submitted

September 17, 2024

First Posted

September 19, 2024

Study Start

November 15, 2022

Primary Completion

November 22, 2022

Study Completion

March 25, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)