The Restoration of Endodontically Treated Teeth Using Indirect Full Coverage Restorations Compared to Direct Composite Resin Restorations
-
- STATUS
- Recruiting
-
- participants needed
- 60
-
- sponsor
- University of Jordan
Summary
The use of full cuspal coverage restoration for the management root treated teeth was advocated by many clinical studies and supported by systematic reviews. However, most of the studies did not take into account the amount of tooth structure remaining before providing cuspal coverage. The strength and fracture resistance of the tooth has been shown to be positively correlated with the amount of tooth structure remaining. A more conservative treatment option could be selected for a root treated tooth with good amount of remaining tooth structure such as direct restorations.
The aims of this randomized clinical trial is to compare the survival and success of root treated teeth with occlusal cavities and at least three intact axial walls, when restored through the use of indirect full cuspal coverage restorations vs direct composite resin restorations.
Description
The management of posterior endodontically treated teeth (ETT) is still to this day considered a controversial topic.The use of full cuspal coverage restoration for the management ETT was advocated by many clinical studies and supported by systematic reviews. However, most of the studies did not take into account the amount of tooth structure remaining before providing cuspal coverage. An ETT tooth with an MOD cavity will be at a higher risk of fracture than an ETT tooth with just an occlusal cavity. Managing both with cuspal coverage could be considered an overtreatment and an unnecessary removal of tooth structure. The strength and fracture resistance of the tooth has been shown to be positively correlated with the amount of tooth structure remaining. A more conservative treatment option could be selected for an ETT with good amount of remaining tooth structure such as direct restorations.
The aims of this randomized clinical trial is to compare the survival and success of ETT with occlusal cavities and at least three intact axial walls, when restored through the use of indirect full cuspal coverage restorations vs direct composite resin restorations.
The groups are:
Group 1: Managed with direct intracoronal composite resin restoration. Group 2: Managed with a direct composite resin restoration, followed by an indirect full coverage restoration.
Patients will be recalled at 1 year, 3 years and 5 years.
Treatment protocol for each group Group 1: Patient receiving a composite resin restoration. Following rubber dam isolation, the temporary restoration will be removed. The enamel will be selectively etched with 37% phosphoric acid and rinsed and dried thoroughly till a white frost appearance appeared. An adhesive system (ScotchBond Multi-Purpose - 3M ESPE) will then be applied to the dentine according to the manufacturer instructions and then will be cured for 30 seconds. The direct restoration will be made using a microhybrid resin composite (Filtek Z350, 3M ESPE), which will be applied in increments and each increment cured for 40 seconds. Glycerin will be applied to the final restoration and cured for 5 seconds to prevent the development of the oxygen inhibition layer. The restoration will then be finished with ultra-fine diamond finishing burs, and polished with Sof-Lex discs (3M ESPE) and 0.1 micrometer particle size diamond paste. Occlusion will be checked to conform to the patient's current occlusion status and make sure no interferences were introduced.
Group 2: Patients receiving a composite resin restoration and followed with an indirect full coverage restoration.
The same steps used as for group 1 would be followed to build the composite resin core. This will be followed with a preparation for the indirect full cuspal restoration. Three additional silicone putty indices will be made; one will be made for the production of a provisional crown, and the other two will be cut and used as reduction indices (one will be cut mesio-distally and the other one will be cut facially-lingually/palatally). The preparation will be carried out with diamond burs. The guidelines to be followed will
- include
-
- Supra or equigingival margins if aesthetic was of concern.
- Chamfer finish-line
- 2 mm occlusal reduction;
- 1.5 mm axial reduction all around Following the application of two double retraction cord sizes 00 and 0 (Ultradent), the impression will be made with additional silicone (Zermack) and the cast poured in Die stone. The crown will be fabricated in the laboratory.
The temporary crown made from self-cure bisacrylic (Protemp, 3M ESPE) would be cemented using Eugenol free temporary crown and bridge cement (TempBond). All crowns will be cemented after 1 week using Resin modified glass ionomer cement (RelyX luting plus, 3M ESPE).
Follow-up appointments and data Collection
Clinical evaluation will include:
- Visual inspection conducted with loops at magnification 4.5
- Examination of the continuity of the margins of the restoration with the tooth structure by use of an explorer
- Periodontal probing performed with a periodontal probe.
- Color photos (1:1 mirror shots) of the restorations were taken with standard film
- Periapical and bitewing radiographic examination was performed by use of a paralleling technique at 65 kV and 8 mA.
- Patients reported outcome measures (PROM)
Evaluation of success or failure will be performed by 2 examiners other than the operator.
Details
Condition | Tooth, Nonvital |
---|---|
Age | 18years - 100years |
Treatment | Direct composite resin restoration, Direct composite resin restoration followed by full coverage metal ceramic crown |
Clinical Study Identifier | NCT04249726 |
Sponsor | University of Jordan |
Last Modified on | 19 February 2024 |
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteerStudy AnnotationsStudy Notes
Notes added here are public and can be viewed by anyone. Notes added here are only available to you and those who you share with.
Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!
No annotations made yet
Add a private note
- Select a piece of text from the left.
- Add notes visible only to you.
- Send it to people through a passcode protected link.
Study Definition
WikipediaAdd a private note
- Select a piece of text.
- Add notes visible only to you.
- Send it to people through a passcode protected link.