NCT04438642

Brief Summary

Aim of study: is to asses biological and esthetical success of ceramic onlay restorations while preparing the teeth using shoulder finish line preparation versus butt joint with bevel preparation. Methods: Patients with need to posterior onlay restoration (premolars and molars) will be allocated into two groups either conventional (shoulder finish line) or conservative group (butt joint with bevel), after tooth preparation impression, restoration fabrication, try in, cementation and restoration will be evaluated two weeks post cementation then follow up will be held every two months for 1 year.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 9, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

2.1 years

First QC Date

February 25, 2020

Last Update Submit

July 28, 2021

Conditions

Unsatisfactory Restoration of ToothCarious Teeth

Keywords

ceramic onlayconventional preparationconservative preparationButt joint with bevelshoulder finish linebiologic response

Outcome Measures

Primary Outcomes (1)

  • postoperative sensitivity

    pain immediately after restoration cementation

    1 year follow up

Secondary Outcomes (1)

  • Marginal Discoloration

    1 year follow up

Other Outcomes (1)

  • secondary carries

    1 year follow up

Study Arms (2)

conventional ceramic onlay with shoulder finishline

OTHER

tooth that need ceramic onlay restoration, a conventional cavity will be prepared with shoulder finishline.

Procedure: shoulder finishline

conservative ceramic onlay preparation buttjoint with bevel

EXPERIMENTAL

tooth that need ceramic onlay restoration, a conservative cavity will be prepared with butt joint with bevel finishline.

Procedure: butt joint with bevel

Interventions

shoulder finishlinePROCEDURE

tooth will be prepared having shoulder finishline.

conventional ceramic onlay with shoulder finishline
butt joint with bevelPROCEDURE

tooth will be prepared having butt joint with bevel finishline.

conservative ceramic onlay preparation buttjoint with bevel

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • From 18-70 years old, be able to read and sign the informed consent document.30 2- Have no active periodontal or pulpal diseases, have teeth with good restorations.
  • Psychologically and physically able to withstand conventional dental procedures 4- Patients with teeth problems indicated for posterior onlay (molars or premolars).
  • Decayed teeth
  • Teeth restored with large filling restorations 5- Able to return for follow-up examinations and evaluation

You may not qualify if:

  • Patient less than 18 or more than 70 years
  • Patient with active resistant periodontal diseases
  • Patients with poor oral hygiene, high caries risk 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. 8- the presence of a removable or fixed orthodontic appliance, signs of bruxism or clenching, the absence of more than one unit in the posterior region.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university Faculty Of Dentistry Fixed Prosthodontics clinic

Giza, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
double blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD researcher

Study Record Dates

First Submitted

February 25, 2020

First Posted

June 19, 2020

Study Start

November 9, 2019

Primary Completion

January 1, 2022

Study Completion

February 1, 2022

Last Updated

July 29, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

the outcome results

Locations

EG(1)