Clinical trial NCT04095520: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dental Erosion
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2019-09-19
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Evaluation the Changes of Surface Luster
timeFrame: 1st day, 1st week,6th month, 1st year
measure: Evaluation the Changes of Retention
timeFrame: 1st day, 1st week,6th month, 1st year
measure: Evaluation the Changes of Surface Staining
timeFrame: 1st day, 1st week,6th month, 1st year
measure: Evaluation the Changes of Color Stability and Translucency
timeFrame: 1st day, 1st week, 6th month, 1st year
measure: Evaluation the Changes of Anatomic Form
timeFrame: 1st day, 1st week, 6th month, 1st year
measure: Evaluation the Changes of Marginal Adaptation
timeFrame: 1st day, 1st week, 6th month, 1st year
measure: Evaluation the Changes of Wear
timeFrame: 1st day, 1st week, 6th month, 1st year
measure: Evaluation the Changes of Patients View
timeFrame: 1st day, 1st week, 6th month, 1st year
measure: Evaluation the Changes of Postoperative (hyper-)sensitivity and tooth vitality
timeFrame: 1st day, 1st week, 6th month, 1st year
measure: Evaluation the Changes of Recurrence of Caries, Erosion, Abfraction
timeFrame: 1st day, 1st week, 6th month, 1st year
measure: Evaluation the Changes of Tooth integrity
timeFrame: 1st day, 1st week, 6th month, 1st year
measure: Evaluation the Changes of Periodontal response
timeFrame: 1st day, 1st week, 6th month, 1st year
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Van Yuzuncu Yil University, Faculty of Dentistry
Study officials:
References:
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.
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.