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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04532671
Other study ID # 88245
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date October 1, 2022

Study information

Verified date August 2020
Source Cairo University
Contact donia M elshafey, master
Phone 1008820027
Email donia.mamdouh@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In patients using Inlay restorations will the use of 3D printed PEEK material and technique have superior clinical performance to milled PEEK one or to milled composite resin inlays, evaluation of restorations will be done at baseline, six months and 12 months using the modified US Public Health Service (USPHS) evaluation system


Description:

The study will be conducted in Conservative Dentistry Department, Faculty of Dentistry, Cairo University; The operator in charge will be Donia Mamdouh Elshafey Patients will be selected from the outpatient clinic of the department Conservative Dentistry Department, Faculty of Dentistry, Cairo University All cavity preparations will be performed with fine inlay burs according to inlay cavity principles. The walls facing each other will be prepared 5 to 6 degree divergent with 80 μm diamond burs and were finished with 25 μm diamond burs. All internal angles will be rounded and all edges will terminate in the enamel. The pulpal floor will be prepared at a depth of at least 1.5 mm. The teeth will be discarded if isthmus width was more than 2/3 of the distance between the tubercule tips, or if the walls are thinner than 2 mm before the preparation or thinner than 1.5 mm after the preparation. The caries affected dentin tissue at the cavity floor will be left. The teeth will be discarded from study if the pulp is exposed. To eliminate irregular areas in the cavities, a liner will be applied as a blockout material. Then the operator will adhere strictly to the manufacturer's instructions in the imaging, computer design and machining of the restorations either 3D printing or milling procedure.

The prepared teeth for the indirect restorations will be scanned with an optical 3D camera (CEREC Omnicam, Dentsply Sirona, Bensheim, Germany), inlays will be designed by a CAD software (CEREC SW 4.6.1, Dentsply Sirona), and files will be created in STL format (inLab CAD SW 18.1, Dentsply Sirona) then inlays will additively manufactured After the printing process is finished, the inlays will be immediately removed from the building platform and cooled down at room temperature. The inlay will be adapted individually to its cavity, and the occlusal surface will be recontoured. Such post processing also will be performed on the milled inlays. After all inlays are adequately adapted, they will be adhesively inserted into the cavities.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date October 1, 2022
Est. primary completion date October 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients aging greater than or equal 18 years.

- Patients with a high level of oral hygiene.

- Each patient enrolled in the study had moderate to large size carious lesion or defective restoration to be replaced on a maxillary or mandibular permanent molar.

- Patients with good likelihood of recall availability.

Exclusion Criteria:

- Participants with general/systemic illness.

- Pregnant or lactating females.

- Concomitant participation in another research study.

- Inability to comply with study procedures.

- Heavy bruxism habits.

- Last experience with allergic reactions against any components of the used materials.

- Patients receiving orthodontic treatment.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Poly ether ether ketone (PEEK)
PEEK has been used in dentistry so far in certain fields as for, removable and fixed dental prostheses, implants, and implant abutments as well as orthodontic devices, whereas in literature, it is mostly mentioned in relation to prosthetics. PEEK was predominantly processed out of CAD/CAM-supported milled out of prefabricated blanks. Producing dental restorations via Additive manufacturing is still hardly widespread
CADCAM Poly ether ether ketone (PEEK)
Increased demand for long-lasting restoration's properties have led to many improvements in the production techniques of posterior restorations such as CAD/CAM systems. This technique simplifies the production of indirect restorations and make it possible to use advanced materials as PEEK
indirect resin composite
CADCAM resin composite blocks using milling process

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary Marginal integrity Visual inspection with explorer and mirror, Distance penetrated by the Explorer at the tooth restoration interface 12 months
Primary marginal discoloration Visual inspection with a mirror at 18 inches, the degree of mismatch from the normal range of tooth shades and translucency Visual inspection to check the proximity of the shade from the natural tooth 12 months
Primary secondary caries Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time 12 months
Primary post operative sensitivity Asking the patient if there is any associated pain after adding the restoration 12 months
See also
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Not yet recruiting NCT06097143 - Clinical Performance of Flowable Giomer Versus Nanofilled Composite in Conservative Occlusal Cavities N/A
Not yet recruiting NCT04354636 - Management of Occlusal Caries Using Silver Modified Atraumatic Restorative Treatment Versus Atraumatic Restorative Treatment Phase 2/Phase 3
Recruiting NCT05969756 - Early Treatments for Preventing Occlusal Caries Lesions N/A
Active, not recruiting NCT06260644 - Evaluation of Using Self-adhering Flowable Resin Composite in Repairing Old Defective Resin Composite Restorations Over 18 Months Follow up. (A Randomized Clinical Trial) N/A