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Nano-Hybrid vs Bulk-Fill Resin Composites

Primary Purpose

Composite Resin, Dental Caries in Children

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bulk-fill composite resin
Nano-fill composite resin
Sponsored by
Izmir Katip Celebi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Composite Resin

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Izmir Katip Celebi University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bulk-fill composite resin

Nano-fill composite resin

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
June 16, 2022
Last Updated
September 29, 2023
Sponsor
Izmir Katip Celebi University
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1. Study Identification

Unique Protocol Identification Number
NCT05432258
Brief Title
Nano-Hybrid vs Bulk-Fill Resin Composites
Official Title
Evaluation of the Nano-Hybrid and Bulk-Fill Resin Composites: Randomised Controlled Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 15, 2020 (Actual)
Primary Completion Date
July 26, 2022 (Actual)
Study Completion Date
July 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Katip Celebi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Composite Resin, Dental Caries in Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Masking Description
Double blind
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bulk-fill composite resin
Arm Type
Experimental
Arm Description
Bulk-fill Ormocer composite resin restorations on the mandibular first molars applied in layers of 4 mm depth
Arm Title
Nano-fill composite resin
Arm Type
Active Comparator
Arm Description
Nano-fill composite resin restorations on the mandibular first molars were applied in layers of 2 mm depth
Intervention Type
Device
Intervention Name(s)
Bulk-fill composite resin
Other Intervention Name(s)
Admira Fusion x-tra (Voco GmbH, Cuxhaven, Germany)
Intervention Description
Restoration of the mandibular first molars with bulk-fill composite resin as the manufacturer advises after the cavity preparation
Intervention Type
Device
Intervention Name(s)
Nano-fill composite resin
Other Intervention Name(s)
Grandio (Voco , Cuxhaven, Germany)
Intervention Description
Restoration of the mandibular first molars with nano-fill composite resin as the manufacturer advises after the cavity preparation
Primary Outcome Measure Information:
Title
Comparison of clinical performances between two restorative materials according to World Dental Federation (FDI)(1-5 scale; 1 best, 5 worst)
Description
Change of World Dental Federation (FDI) scores of restoration from baseline to 2 year
Time Frame
immediately after restoration and 24 months control
Title
Comparison of clinical performances between two restorative materials according to US Public Health Service (USPHS) criteria (Alfa-best, Bravo, Charlie-worst)
Description
Change of the US Public Health Service (USPHS) scores of restoration from baseline to 2 year
Time Frame
immediately after restoration and 24 months control

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Izmir Katip Celebi University
City
İzmir
Country
Turkey

12. IPD Sharing Statement

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Nano-Hybrid vs Bulk-Fill Resin Composites

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