NCT07786272

Brief Summary

This study aims to evaluate and compare the impact of khat chewing on the color stability and patient satisfaction of multilayer zirconia and feldspathic veneered zirconia restorations. A split-mouth clinical trial design is utilized to assess color changes using a spectrophotometer and patient satisfaction via a structured questionnaire over the follow-up period.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Jan 2026

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

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Study Timeline

Key milestones and dates

Study Progress56%
Jan 2026Mar 2027

Study Start

First participant enrolled

January 1, 2026

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2027

Last Updated

August 25, 2026

Status Verified

August 1, 2026

Enrollment Period

1.1 years

First QC Date

August 21, 2026

Last Update Submit

August 21, 2026

Conditions

Keywords

Multilayer ZirconiaFeldspathic Veneered ZirconiaSplit-Mouth StudySpectrophotometerPatient Satisfaction

Outcome Measures

Primary Outcomes (1)

  • Color stability

    Assessment of color change (delta E) of the restorations measured using a spectrophotometer.

    Baseline, 3 months, and 6 months

Secondary Outcomes (1)

  • Patient Satisfaction

    6 months

Study Arms (2)

Multilayer Zirconia Group

EXPERIMENTAL

Restorations fabricated using multilayer zirconia in one arch.

Device: Multilayer Zirconia Crowns

Feldspathic Veneered Zirconia Group

ACTIVE COMPARATOR

Restorations fabricated using feldspathic veneered zirconia in the opposing arch.

Device: Feldspathic Veneered Zirconia Crowns

Interventions

Multilayered zirconia restorations placed in one arch.

Multilayer Zirconia Group

Feldspathic veneered zirconia Restorations Placed in the opposing arch.

Feldspathic Veneered Zirconia Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age \> 18 years old.
  • Participants required crowns with proper endodontic treatment.
  • Participants with stable normal occlusion.
  • Khat chewer.
  • Participants required crowns for posterior teeth (premolar and molar) in the side of khat chewing.
  • Participants with extensive decay, cracks, or large restorations that necessitate a crown.
  • Participants wishing to improve the appearance of discolored or damaged teeth may be suitable candidates for crowns.
  • Good oral hygiene.
  • Availability for follow-up

You may not qualify if:

  • Participants with high caries index.
  • Participants with parafunctional habits as clenching/bruxism.
  • Severe periodontal disease.
  • Participants not indicated for crowns.
  • Allergy to materials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thamar University , Faculty of Dentistry

Dhamar, Yemen

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a split-mouth clinical trial. Each participant receives both restoration types simultaneously on the same side: multilayer zirconia in one arch (maxillary or mandibular) and feldspathic veneered zirconia in the opposing arch, assigned randomly.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master candidate , Department of Prosthodontics , Faculty of Dentistry

Study Record Dates

First Submitted

August 21, 2026

First Posted

August 25, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

March 12, 2027

Last Updated

August 25, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared to protect participant privacy and maintain confidentiality.

Locations