Longevity of Dental Fillings Utilizing 3D Printing

NCT04630587 | Enrolling By Invitation

• 1 other identifier: 2924410-5
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to compare the success of dental fillings prepared using 3D printing technique to those manufactured with the direct composite technique. A total of 100 adult patients will be selected from dental patients attending Kaarina Municipal Health Care Centre from October 2020. The inclusion criteria are as follows: presence of multiple cavities, fractures or cosmetic demands on bilateral permanent teeth. The restorative demand should be a class II, III or IV on first or second molars, or premolars. At least two fillings should be from the same tooth group (premolar/molar) in each patient. This will be a split-mouth study, whereby one tooth on one side will be restored using direct technique, and the contra lateral tooth restored using the indirect technique through random allocation. For both direct and indirect restorations, commercially available short-fibre reinforced composite material (Ever X Flow, GC) is used for core material (replacing dentin) and flowable composite material (Gaenial Universal Injectable, GC) for surface (replacing enamel, appr. 2mm thickness from the surface), according the manufacturer´s instructions. Clinical evaluations will be conducted immediately after the final finishing, and after 1 year, 3 years and 5 years. The evaluation will be based on the United States Public Health Service (USPHS) criteria. Descriptive statistics will be used to describe the frequency distributions of the evaluated criteria. To analyse the failure rate for direct vs. indirect restorations, 2x2 tables will be created. Non-parametric statistical procedures will be used due to ordinally structured data for the assessment of the restorations. Mann-Whitney U-test will be used to explore significant differences at different time points between direct and indirect restorations.

Conditions

Dental Restoration Failure of Marginal Integrity; Dental Caries

Outcome Measures

Primary Outcomes (1)

• The United States Public Health Service (USPHS) criteria; changes during the follow-up period

  The USPHS criteria include the following evaluations: retention, postoperative sensitivity, secondary caries, colour match, anatomical form, marginal discoloration, marginal adaptation, and surface texture. This clinical assessment method results in ordinally structured data for the outcome variables (A, Alpha = excellent result; B, Bravo = acceptable result; C, Charlie = unacceptable, replacement of the restoration necessary).

  baseline, and 1 year, 3 years and 5 years after baseline

Study Arms (2)

Indirect restorations

EXPERIMENTAL

For the indirect technique, the cavities are prepared according to the common principles for inlays/onlays. Digital impressions are taken of each tooth with a digital impression system (3Shape TRIOS® Intraoral Scanner).The dentist, utilizing the scanner's CAD SW, designs the 3D restoration. The design is imported from the scanner SW into the Rayo 3DToothFill SW to manufacture the mould and the restoration. After printing the mould, it is transferred to the Rayo robot which manufactures the restoration by casting filling material layers in the mould. The automated filling and curing procedures in the Rayo 3DToothFill robot are directed by Rayo 3DToothFill SW. After the manufacturing process is finished, the dentist cements the finished restoration into the cavity with a dual-cure resin cement (G-CEM LinkAce®).The indirect fillings are manufactured chair-side from the same composite material as in the direct technique.

Procedure: Indirect restorations

Direct restorations

ACTIVE COMPARATOR

The direct composite restorations are performed based on normal treatment practices. For both direct and indirect restorations, commercially available short-fibre reinforced composite material (everX Flow, GC) is used for core material (replacing dentin) and flowable composite material (G-ænial® Universal Injectable, GC) for surface (replacing enamel), according the manufacturer´s instructions. The occlusion and articulation are checked and adjusted, and the restoration is finished with polishing instruments.

Procedure: Indirect restorations

Interventions

Indirect restorations PROCEDURE

see the Arm description

Direct restorations; Indirect restorations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• presence of cavities, fractures or cosmetic demands
• first or second molars and permanent premolars needing restorations
• at least two class II restorations from the same tooth group (premolar/molar) should be performed in each patient
• the number of restorations of each technique should be equal in each patient

You may not qualify if:

• pulp exposure or risk of it during caries removal or cavities with imminent risk of pulp exposure
• spontaneous pain or sensitivity to percussion

Sponsors & Collaborators

• University of Oulu: lead
• University of Helsinki: collaborator
• Oulu University Hospital: collaborator
• University of Turku: collaborator
• University of Eastern Finland: collaborator

Study Sites (1)

Research Unit of Oral Health Sciences, University of Oulu

Oulu, 90014, Finland

Location

Related Publications (18)

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MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Kirsi Sipilä, Professor

  University of Oulu, Finland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Restorations are rated independently by blinded dentists who are not involved with the insertion of the indirect and the direct restorations and are unaware of the group status of the fillings.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each patient requires pairwise number of restorations. The randomizations are performed by each tooth to be restored by direct technique vs. indirect technique utilizing 3D printing.

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 16, 2020
• Study Start: September 15, 2020
• Primary Completion: March 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 16, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)