NCT06803537

Brief Summary

This study aimed to perform a comparison between the clinical performance of short fiber-reinforced composite and indirect lab composite restorations in posterior dentition.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

May 11, 2025

Status Verified

January 1, 2025

Enrollment Period

3.5 years

First QC Date

January 27, 2025

Last Update Submit

May 8, 2025

Conditions

Occlusal CariesProximal Caries

Keywords

fiber-reinforced compositeindirect lab compositeposterior restorations

Outcome Measures

Primary Outcomes (1)

  • FDI criteria for evaluation

    Three years follow-up

Study Arms (3)

Fiber-reinforced composite

ACTIVE COMPARATOR
Other: indirect lab compositeOther: Conventional resin composite

Indirect lab composite

ACTIVE COMPARATOR
Other: Fiber-reinforced compositeOther: Conventional resin composite

Conventional microhybrid resin composite

ACTIVE COMPARATOR
Other: Fiber-reinforced compositeOther: indirect lab composite

Interventions

Fiber-reinforced compositeOTHER

short fiber-reinforced composite used as base covered by conventional composite

Conventional microhybrid resin compositeIndirect lab composite
indirect lab compositeOTHER

indirect lab processed resin composite inlay restorations

Conventional microhybrid resin compositeFiber-reinforced composite
Conventional resin compositeOTHER

conventional microhybrid resin composite posterior restorations

Fiber-reinforced compositeIndirect lab composite

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients aged 20-35 year from both genders.
  • Good oral hygiene: patients with low and moderate caries risk (according to Caries management by caries risk assessment CAMBRA sheets) were enrolled in this study.
  • The visual examination should reveal the presence of a minimum of three primary occlusal or proximal caries (Black Class I and II) with a severity score of 4 or 5 according to the International Caries Detection and Assessment System (ICDAS).
  • The carious teeth must exhibit vitality and do not display periapical radiolucency as evaluated by periapical radiography.
  • The selected teeth must be under stable occlusion.

You may not qualify if:

  • Uncontrolled systemic disease
  • Extremely poor oral hygiene
  • Chronic periodontitis
  • Heavy bruxism
  • Cavities with a buccolingual width exceeding two-thirds of the intercuspal distance or requiring cusp covering.
  • Patients undergoing orthodontic procedures.
  • Patients unable to attend the scheduled recall appointments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura university

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2025

First Posted

January 31, 2025

Study Start

January 1, 2022

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

May 11, 2025

Record last verified: 2025-01

Locations

EG(1)