Nano-Hybrid vs Bulk-Fill Resin Composites

NCT05432258 | Completed DMC

• 1 other identifier: E.728477
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the 2-year clinical performance of bulk-fill composites, which can be applied as a single layer, and the nano-hybrid filled composite resins, which are frequently used in clinical routine, in children in a split-mouth design. This study was conducted on 89 patients aged 6-12 years who had caries on bilateral mandibular first molars. Our study has a randomized, cross-controlled, and double-blind design. In split-mouth design, restorations of mandibular permanent molars completed with nano-hybrid ORMOCER based bulk-fill filling material Admira Fusion x-tra (Voco GmbH, Cuxhaven, Germany) and nano-hybrid composite Grandio (Voco , Cuxhaven, Germany). Futurabond U single dose (Voco, Cuxhaven, Germany) universal adhesive was used for all restorations, in the selective enamel etching mode. The clinical success of the restorations will be evaluated at 6, 12 and 24-month controls. Evaluations has been made by two physicians other than the one who did the restoration, who do not know which restorative material was applied to which tooth.

Conditions

Composite Resin; Dental Caries in Children

Outcome Measures

Primary Outcomes (2)

• Comparison of clinical performances between two restorative materials according to World Dental Federation (FDI)(1-5 scale; 1 best, 5 worst)

  Change of World Dental Federation (FDI) scores of restoration from baseline to 2 year

  immediately after restoration and 24 months control

• Comparison of clinical performances between two restorative materials according to US Public Health Service (USPHS) criteria (Alfa-best, Bravo, Charlie-worst)

  Change of the US Public Health Service (USPHS) scores of restoration from baseline to 2 year

  immediately after restoration and 24 months control

Study Arms (2)

Bulk-fill composite resin

EXPERIMENTAL

Bulk-fill Ormocer composite resin restorations on the mandibular first molars applied in layers of 4 mm depth

Device: Bulk-fill composite resin

Nano-fill composite resin

ACTIVE COMPARATOR

Nano-fill composite resin restorations on the mandibular first molars were applied in layers of 2 mm depth

Device: Nano-fill composite resin

Interventions

Bulk-fill composite resin DEVICE

Restoration of the mandibular first molars with bulk-fill composite resin as the manufacturer advises after the cavity preparation

Also known as: Admira Fusion x-tra (Voco GmbH, Cuxhaven, Germany)

Bulk-fill composite resin

Nano-fill composite resin DEVICE

Restoration of the mandibular first molars with nano-fill composite resin as the manufacturer advises after the cavity preparation

Also known as: Grandio (Voco , Cuxhaven, Germany)

Nano-fill composite resin

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Black class I or II caries on two bilateral mandibular permanent molars; clinically at score 3, 4 and 5 according to the ICDAS II (International Caries Detection and Evaluation System); and radiographically; with D2-RB4 and D3-RC5 levels
• plaque index (Silnes and Löe, 1964) scores of the teeth to be processed was 0 and 1
• the gingival index (Löe and Silness, 1963) score was 0

You may not qualify if:

• On the teeth to be processed; color change in the pits and fissures of the tooth, with no signs of caries after air drying for 5 seconds (ICDAS II Scale score 0), discoloration or opacity that is not visible when moist but observed after drying (ICDAS II Scale score 1), observable when both moist and dry or with opacity (ICDAS II Scale score 2), containing more than half of the tooth, with a large cavity in which dentin is observed (ICDAS II Score 6), Black class I and/or class II enamel-dentin caries,
• The values accepted in the evaluation of radiographic dental caries in the teeth for which the procedure is planned are E0-R0 (no radiolucency), E1-RA1 (radiolucency in the upper ½ of the enamel), E2-RA2 (radiolucency extending to the radiolucency-enamel-dentin junction in the lower ½ of the enamel) , with D1-RA3 (radiolucency observed in the upper 1/3 of the dentin),
• Non-antagonist of the teeth to be processed,
• In the gingival region of the teeth to be treated, there are areas covered with plaque from thin to medium thickness (plaque index score 2) and areas where the plaque thickness fills the gingival sulcus and where the soft attachment is high (plaque index score 3) (Löe and Silness, 1964),
• Bleeding and inflammation in the gingiva of the tooth to be treated (gingival index score (Löe and Silness, 1963) 1,2 and 3),
• Devitalized teeth for which the procedure is planned,
• The patient's lack of cooperation and physician cooperation to have the procedures performed (Score 1 and 2 on the Frankl behavioral scale).
• Having any systemic disease that prevents the treatment (ASA 2,3,4,5,6)
• Patients who will not comply with their appointments will not be included in the study

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Izmir Katip Celebi University

Izmir, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Model Details: In a split-mouth design, 89 patients' 2 mandibular first molars were divided into 2 groups. Per patient, one mandibular first molar had bulk-fill ormocer-based composite resin restoration and 1 mandibular first molar had nanofill composite resin restoration via incremental technic.

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 27, 2022
• Study Start: June 15, 2020
• Primary Completion: July 26, 2022
• Study Completion: July 26, 2022
• Last Updated: October 2, 2023

Record last verified: 2023-09

Locations

TU (1)