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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.
Research objective: The aim of this 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.
Research Procedure:
C: comparator: shoulder finish line preparation for ceramic onlay.
O: Outcome:
Primary: Postoperative sensitivity Secondary: Marginal discoloration Tertiary: Secondary Caries T: Time: 1 year. S: Study design: Randomized controlled clinical trial.
Research question For patients requiring posterior onlays, does the use of conservative preparation offer better biological response and esthetics when compared to conventional onlay preparation?
Participant timeline:
The patient will be treated in visits designated as follows:
Allocation
Randomization:
- Simple randomization will be done using computerized random number generator
Allocation:
Data collection methods:
Plans to promote participant retention & complete follow-up:
D) Data monitoring
Monitoring
The main supervisor is responsible of data monitoring if harms arise, interim analysis will be done.
Harms
The main investigator will record, document and treat any adverse effect like pain or even failure.
Expected risk to the human subjects:
Consent
Researcher will discuss the trial with all patients. Patients will then be able to have an informed discussion with the researcher. Researcher will obtain written consent from patients willing to participate in the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional ceramic onlay with shoulder finishline | Other | tooth that need ceramic onlay restoration, a conventional cavity will be prepared with 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| shoulder finishline | Procedure | tooth will be prepared having shoulder finishline. |
|
| Measure | Description | Time Frame |
|---|---|---|
| postoperative sensitivity | pain immediately after restoration cementation | 1 year follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Marginal Discoloration | Margins between tooth and restoration have discoloration. Measuring device: visual and probe (used according to USPHS instructions) Measuring unit: Alpha, Bravo B1, Bravo B2, Charlie (according to USPHS measuring units) as following: Alpha: no discoloration along the margin. Bravo B1: discoloration noted along the margin less than 50 percent of exposed margin. Bravo B2: discoloration noted along the margin greater than 50 percent of exposed margin. Charlie: discoloration penetrating along the margin. |
| Measure | Description | Time Frame |
|---|---|---|
| secondary carries | carries that is developed due to restoration Measuring device: visual and probe (used according to USPHS instructions) Measuring unit: Alpha and Bravo (according to USPHS measuring units) as following: Alpha: carries absent along the margin. Bravo: carries present along the margin. | 1 year follow up |
Inclusion Criteria:
1-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.
3- Psychologically and physically able to withstand conventional dental procedures 4- Patients with teeth problems indicated for posterior onlay (molars or premolars).
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo university Faculty Of Dentistry Fixed Prosthodontics clinic | Giza | Egypt |
the outcome results
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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double blinded
| butt joint with bevel | Procedure | tooth will be prepared having butt joint with bevel finishline. |
|
| 1 year follow up |