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12 Months Clinical Follow-up of Non-Carious Cervical Lesions Restored With New Injectable Composite

Primary Purpose

Dental Erosion

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Laser Etching
Phosphoric acid etching
Sponsored by
Yuzuncu Yıl University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dental Erosion

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with cervical lesions in the mouth with multiples of 4 and 4,

    • Patients over 18 years of age and in permanent dentition,
    • Patients who do not have a pulpal or endodontic lesion on their teeth to be treated,
    • Patients without sensitivity to percussion in the teeth to be treated.

Exclusion Criteria:

Patients with any systemic disease,

  • Pregnant or suspected pregnancy and also breastfeeding patients,
  • Patients who are allergic to any dental material,
  • Patients with any periodontal disease,
  • Patients with poor oral hygiene,
  • In cases where the teeth are exposed to excessive load due to excessive rupture,
  • Cervical caries lesions,
  • Patients who continue orthodontic treatment,
  • Desensitizing agents or fluoride treatment.

Sites / Locations

  • Van Yuzuncu Yil University, Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Paste Type Traditional Composite-GC G Aenial Anterior

Injectable Composite- GC G Aenial Universal Injectable

Arm Description

Non-carious cervical lesions with shallow depth of less than 3 mm will be restored with microhybrid composite

Non-carious cervical lesions with shallow depth of less than 3 mm will be restored with injectable form composite

Outcomes

Primary Outcome Measures

Evaluation the Changes of Surface Luster
Surface luster of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Evaluation the Changes of Retention
Fractures and retention of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Evaluation the Changes of Surface Staining
Surface staining of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Evaluation the Changes of Color Stability and Translucency
Color Stability and translucency of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Evaluation the Changes of Anatomic Form
Anatomic form of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Evaluation the Changes of Marginal Adaptation
Marginal adaptation of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Evaluation the Changes of Wear
Wear of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Evaluation the Changes of Patients View
Patients view of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Evaluation the Changes of Postoperative (hyper-)sensitivity and tooth vitality
Postoperative (hyper-)sensitivity and tooth vitality of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Evaluation the Changes of Recurrence of Caries, Erosion, Abfraction
Recurrence of Caries, Erosion, Abfraction of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Evaluation the Changes of Tooth integrity
Tooth integrity of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Evaluation the Changes of Periodontal response
Periodontal response of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.

Secondary Outcome Measures

Full Information

First Posted
September 11, 2019
Last Updated
February 17, 2022
Sponsor
Yuzuncu Yıl University
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1. Study Identification

Unique Protocol Identification Number
NCT04095520
Brief Title
12 Months Clinical Follow-up of Non-Carious Cervical Lesions Restored With New Injectable Composite
Official Title
Non-Carious Cervical Lesions Restored With Different Etching Methods and New Injectable Composite: One Year Clinical Follow-Up
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
January 25, 2022 (Actual)
Study Completion Date
January 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Non-carious cervical lesions are defined as loss of pathological material not associated with caries in the enamel-cement junction of the tooth. The etiology of these lesions has been defined as brush abrasion, acid-induced erosion and abstraction due to microstructure losses due to stress concentration in a particular region of the tooth. These lesions should be restored using minimally invasive techniques. The necessity of restorative treatment is directly related to the size of the lesion, sensitivity and aesthetic requirements. However, restorative procedures are often challenging because the cavity preparation does not provide adequate retention, and often the cervical end margin is positioned under the gingiva. This leads to contamination of the operation site with blood, saliva and gingival fluid. Several restorative options have been proposed for the treatment of cervical caries-free lesions. However, due to their high aesthetic properties, improved adhesive capacity and mechanical properties, composites have been accepted as the most suitable choice. Clinical studies have demonstrated that marginal adaptation, marginal discoloration, and roughening methods for retention are the most important factors in the clinical performances of composite restorations in cervical lesions. Therefore, injectable composites with wettability and better adaptability to cavity margins have been introduced. However, the low filler contents of fluid composites and their weak mechanical properties compared to conventional composites have led researchers to doubt their use in caries-free cervical lesions. As a result of the developed material technology, injectable composites with high filler which have reduced polymerization shrinkage have been developed with simplified filler procedure. However, investigators have not encountered any studies investigating which etching technique this material will exhibit better clinical performance and comparing it with traditional pasty composites. The aim of this study is to evaluate the clinical performance of traditional paste type and injectable composites which will be made by using two different etching techniques.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Erosion

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paste Type Traditional Composite-GC G Aenial Anterior
Arm Type
Active Comparator
Arm Description
Non-carious cervical lesions with shallow depth of less than 3 mm will be restored with microhybrid composite
Arm Title
Injectable Composite- GC G Aenial Universal Injectable
Arm Type
Experimental
Arm Description
Non-carious cervical lesions with shallow depth of less than 3 mm will be restored with injectable form composite
Intervention Type
Procedure
Intervention Name(s)
Laser Etching
Intervention Description
Before the restorations, cavities will be etched Er:Cr YSGG laser with 4W output power, water pressure 95% and air pressure 60% with MGG6 tip with the spot size of 600 µm will be used.
Intervention Type
Procedure
Intervention Name(s)
Phosphoric acid etching
Intervention Description
Before the restorations, cavities will be etched with %37 phosphoric acid for 15 seconds.
Primary Outcome Measure Information:
Title
Evaluation the Changes of Surface Luster
Description
Surface luster of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Time Frame
1st day, 1st week,6th month, 1st year
Title
Evaluation the Changes of Retention
Description
Fractures and retention of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Time Frame
1st day, 1st week,6th month, 1st year
Title
Evaluation the Changes of Surface Staining
Description
Surface staining of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Time Frame
1st day, 1st week,6th month, 1st year
Title
Evaluation the Changes of Color Stability and Translucency
Description
Color Stability and translucency of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Time Frame
1st day, 1st week, 6th month, 1st year
Title
Evaluation the Changes of Anatomic Form
Description
Anatomic form of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Time Frame
1st day, 1st week, 6th month, 1st year
Title
Evaluation the Changes of Marginal Adaptation
Description
Marginal adaptation of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Time Frame
1st day, 1st week, 6th month, 1st year
Title
Evaluation the Changes of Wear
Description
Wear of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Time Frame
1st day, 1st week, 6th month, 1st year
Title
Evaluation the Changes of Patients View
Description
Patients view of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Time Frame
1st day, 1st week, 6th month, 1st year
Title
Evaluation the Changes of Postoperative (hyper-)sensitivity and tooth vitality
Description
Postoperative (hyper-)sensitivity and tooth vitality of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Time Frame
1st day, 1st week, 6th month, 1st year
Title
Evaluation the Changes of Recurrence of Caries, Erosion, Abfraction
Description
Recurrence of Caries, Erosion, Abfraction of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Time Frame
1st day, 1st week, 6th month, 1st year
Title
Evaluation the Changes of Tooth integrity
Description
Tooth integrity of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Time Frame
1st day, 1st week, 6th month, 1st year
Title
Evaluation the Changes of Periodontal response
Description
Periodontal response of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Time Frame
1st day, 1st week, 6th month, 1st year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with cervical lesions in the mouth with multiples of 4 and 4, Patients over 18 years of age and in permanent dentition, Patients who do not have a pulpal or endodontic lesion on their teeth to be treated, Patients without sensitivity to percussion in the teeth to be treated. Exclusion Criteria: Patients with any systemic disease, Pregnant or suspected pregnancy and also breastfeeding patients, Patients who are allergic to any dental material, Patients with any periodontal disease, Patients with poor oral hygiene, In cases where the teeth are exposed to excessive load due to excessive rupture, Cervical caries lesions, Patients who continue orthodontic treatment, Desensitizing agents or fluoride treatment.
Facility Information:
Facility Name
Van Yuzuncu Yil University, Faculty of Dentistry
City
Van
ZIP/Postal Code
65100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30206572
Citation
Celik EU, Tunac AT, Yilmaz F. A Randomized, Controlled, Split-mouth Trial Evaluating the Clinical Performance of High-viscosity Glass-ionomer Restorations in Noncarious Cervical Lesions: Two-year Results. J Adhes Dent. 2018;20(4):299-305. doi: 10.3290/j.jad.a40985.
Results Reference
result
PubMed Identifier
30120605
Citation
Celik EU, Tunac AT, Yilmaz F. Three-year clinical evaluation of high-viscosity glass ionomer restorations in non-carious cervical lesions: a randomised controlled split-mouth clinical trial. Clin Oral Investig. 2019 Mar;23(3):1473-1480. doi: 10.1007/s00784-018-2575-y. Epub 2018 Aug 17.
Results Reference
result

Learn more about this trial

12 Months Clinical Follow-up of Non-Carious Cervical Lesions Restored With New Injectable Composite

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