NCT07017062

Brief Summary

This randomized clinical trial aims to evaluate the clinical performance of hybrid ceramic occlusal veneers cemented with two different bonding protocols: a self-adhesive bonding protocol with adhesive enhancement (BeautiLink SA cement with BeautiBond Xtreme adhesive) versus another self-adhesive bonding protocol (RelyX U200 self-adhesive resin cement with 3M UNIVERSAL bond).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress59%
Jun 2025Jan 2027

First Submitted

Initial submission to the registry

May 31, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 12, 2025

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

1 month

First QC Date

May 31, 2025

Last Update Submit

June 11, 2025

Conditions

Occlusal Wear of Teeth

Outcome Measures

Primary Outcomes (1)

  • Marginal discoloration

    Measuring device: Modified USPHS criteria Alpha: No discoloration on margin Bravo: Discoloration found at margin Charlie: Discoloration with penetration in a pulpal direction

    18 months

Secondary Outcomes (4)

  • Retention

    18 months

  • Marginal adaptation

    18 months

  • Postoperative hypersensitivity

    18 months

  • Recurrent caries

    18 months

Study Arms (2)

Hybrid ceramic occlusal veneers cemented with Rely X U200 cement

ACTIVE COMPARATOR
Other: hybrid ceramic occlusal veneers

Hybrid ceramic occlusal veneers cemented with BeautiLink SA cement

EXPERIMENTAL
Other: hybrid ceramic occlusal veneers

Interventions

hybrid ceramic occlusal veneersOTHER

occlusal veneers cemented with self adhesive resin cements

Hybrid ceramic occlusal veneers cemented with BeautiLink SA cementHybrid ceramic occlusal veneers cemented with Rely X U200 cement

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 21 years
  • Vital teeth
  • Sufficient tooth structure for veneer retention
  • Willing and able to provide written informed consent
  • Ability to attend all follow-up appointments
  • Adequate oral hygiene as determined by the investigator

You may not qualify if:

  • Patients with active periodontal disease (probing depth \> 4mm, bleeding on probing)
  • Patients with severe parafunctional habits (e.g., bruxism confirmed by clinical examination)
  • Poor oral hygiene (plaque index \> 30%)
  • Pregnancy or nursing
  • Systemic diseases affecting treatment outcomes (e.g., uncontrolled diabetes, immunosuppression)
  • Known allergies to study materials (ceramic, or resin cement components)
  • Inability to comply with study requirements
  • Current participation in other dental clinical trials
  • Active orthodontic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

RECRUITING

Central Study Contacts

Hayat Ibrahim El Banna, Lecturer

CONTACT

00201001248734hayat.elbanna@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 31, 2025

First Posted

June 12, 2025

Study Start

June 1, 2025

Primary Completion

July 1, 2025

Study Completion (Estimated)

January 1, 2027

Last Updated

June 12, 2025

Record last verified: 2025-06

Locations

EG(1)