NCT05250232

Brief Summary

the aim of present study is to evaluate clinically the fracture liability , marginal adaptation , and patient satisfaction of conservative versus conventional ceramic Onlays use e-max press to restore defective restored molar with old restoration or caries. with one or more cusp defect

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Status
unknown

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

First Submitted

Initial submission to the registry

January 9, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

February 27, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2023

Completed
Last Updated

February 22, 2022

Status Verified

February 1, 2022

Enrollment Period

11 months

First QC Date

January 9, 2022

Last Update Submit

February 10, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • evaluation of fracture resistance

    fracture resistance of restorations postoperatively: assessment of the restoration for fracture resistance , by using Measuring device Modified United States Public Health Service (MUSPHS) parameters were used to compare the restorations at baseline and final examination use explorer Measuring unit .Discrete(scores) 1. alpha no evidence of fracture 2. bravo evidence of fracture

    one year

Secondary Outcomes (2)

  • evaluation of marginal adaptation

    1 year

  • evaluation of patient satisfaction to the onlay restoration through questioning the patient about pain during eating , acceptability ,sensitivity

    1 year

Study Arms (2)

onlays conservative

EXPERIMENTAL

conservative onlays preparation with partial cusp coverage only defective cusps

Other: onlays conservative

onlays conventional

ACTIVE COMPARATOR

onlays preparation design conventional as all cusps covered with shoulder finish line preparation

Other: onlays conventional

Interventions

Partial coverage of cusps with shoulder finish line

onlays conservative

all coverage of cusps as overlay with shoulder finish line

onlays conventional

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All subjects are required to be:
  • From 18-50 years old, be able to read and sign the informed consent document. 2- Have no active periodontal or pulpal diseases, have teeth with good restorations 3- Psychologically and physically able to withstand conventional dental procedures 4- Patients with teeth problems indicated for onlay restoration:
  • Decayed teeth
  • Teeth restored with defected filling restorations

You may not qualify if:

  • Patient less than 18 or more than 50 years
  • Patient with active resistant periodontal diseases
  • Patients with poor oral hygiene and uncooperative patients
  • Pregnant women
  • Patients in the growth stage with partially erupted teeth
  • Psychiatric problems or unrealistic expectations
  • Lack of opposing dentition in the area of interest

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Central Study Contacts

Eman Hussein

CONTACT

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
PRINCIPAL INVESTIGATOR
PI Title
assistant lereture must university

Study Record Dates

First Submitted

January 9, 2022

First Posted

February 22, 2022

Study Start

February 27, 2022

Primary Completion

January 15, 2023

Study Completion

August 12, 2023

Last Updated

February 22, 2022

Record last verified: 2022-02