NCT04095520

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2022

Completed
Last Updated

February 18, 2022

Status Verified

February 1, 2022

Enrollment Period

2.4 years

First QC Date

September 11, 2019

Last Update Submit

February 17, 2022

Conditions

Dental Erosion

Outcome Measures

Primary Outcomes (12)

  • 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.

    1st day, 1st week,6th month, 1st year

  • 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.

    1st day, 1st week,6th month, 1st year

  • 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.

    1st day, 1st week,6th month, 1st year

  • 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.

    1st day, 1st week, 6th month, 1st year

  • 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.

    1st day, 1st week, 6th month, 1st year

  • 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.

    1st day, 1st week, 6th month, 1st year

  • Evaluation the Changes of Wear

    Wear of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.

    1st day, 1st week, 6th month, 1st year

  • 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.

    1st day, 1st week, 6th month, 1st year

  • 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.

    1st day, 1st week, 6th month, 1st year

  • 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.

    1st day, 1st week, 6th month, 1st year

  • 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.

    1st day, 1st week, 6th month, 1st year

  • 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.

    1st day, 1st week, 6th month, 1st year

Study Arms (2)

Paste Type Traditional Composite-GC G Aenial Anterior

ACTIVE COMPARATOR

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

Procedure: Laser EtchingProcedure: Phosphoric acid etching

Injectable Composite- GC G Aenial Universal Injectable

EXPERIMENTAL

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

Procedure: Laser EtchingProcedure: Phosphoric acid etching

Interventions

Laser EtchingPROCEDURE

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.

Injectable Composite- GC G Aenial Universal InjectablePaste Type Traditional Composite-GC G Aenial Anterior
Phosphoric acid etchingPROCEDURE

Before the restorations, cavities will be etched with %37 phosphoric acid for 15 seconds.

Injectable Composite- GC G Aenial Universal InjectablePaste Type Traditional Composite-GC G Aenial Anterior

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van Yuzuncu Yil University, Faculty of Dentistry

Van, 65100, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 30206572RESULT

  • 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.

    PMID: 30120605RESULT

MeSH Terms

Conditions

Tooth Erosion

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesTooth Wear

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 11, 2019

First Posted

September 19, 2019

Study Start

September 1, 2019

Primary Completion

January 25, 2022

Study Completion

January 25, 2022

Last Updated

February 18, 2022

Record last verified: 2022-02

Locations

TU(1)