Dental ErosionNCT04095520
12 Months Clinical Follow-up of Non-Carious Cervical Lesions Restored With New Injectable Composite
A study testing Laser Etching and Phosphoric acid etching in people with Dental Erosion, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Erosion
- What is being tested?
- Laser Etching and Phosphoric acid etching
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2019to 25 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 9Show fewer
- Cervical caries lesions,
- Patients who continue orthodontic treatment,
- Desensitizing agents or fluoride treatment.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van Yuzuncu Yil University, Faculty of Dentistry
Van, 65100
About this study
Official title: Non-Carious Cervical Lesions Restored With Different Etching Methods and New Injectable Composite: One Year Clinical Follow-Up
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.
- Conditions
- Dental Erosion
- Being tested
- Laser Etching, Phosphoric acid etching
- Medical subject headings
- Tooth Erosion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser EtchingProcedure or surgery
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.
Phosphoric acid etchingProcedure or surgery
Before the restorations, cavities will be etched with %37 phosphoric acid for 15 seconds.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Laser Etching; Procedure: 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 Receives: Procedure: Laser Etching; Procedure: Phosphoric acid etching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1st day, 1st week, 6th month, 1st year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start1 Sep 2019
- Primary completion25 Jan 2022
- Study completion25 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental ErosionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alperen Degirmenci, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095520
- Sponsor's protocol ID
- 15/ 06.08.2019
- Status last verified
- Feb 2022
- First submitted
- 11 Sep 2019
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30206572Celik 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.
PubMed 30120605
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Carious Cervical Lesions Restored With Different Etching Methods and New Injectable Composite: One Year Clinical Follow-Up
- ClinicalTrials.gov ID
- NCT04095520
- Acronym / sponsor ID
- 15/ 06.08.2019
- Conditions
- Dental Erosion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paste Type Traditional Composite-GC G Aenial Anterior | Active comparator | Procedure: Laser Etching, Procedure: Phosphoric acid etchingNon-carious cervical lesions with shallow depth of less than 3 mm will be restored with microhybrid composite |
| Injectable Composite- GC G Aenial Universal Injectable | Experimental | Procedure: Laser Etching, Procedure: Phosphoric acid etchingNon-carious cervical lesions with shallow depth of less than 3 mm will be restored with injectable form composite |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with cervical lesions in the mouth with multiples of 4 and 4,
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser EtchingBefore 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. | Procedure or surgery | Injectable Composite- GC G Aenial Universal Injectable, Paste Type Traditional Composite-GC G Aenial Anterior |
| Phosphoric acid etchingBefore the restorations, cavities will be etched with %37 phosphoric acid for 15 seconds. | Procedure or surgery | Injectable Composite- GC G Aenial Universal Injectable, Paste Type Traditional Composite-GC G Aenial Anterior |
Primary outcome
Evaluation the Changes of Surface Luster
Time frame: 1st day, 1st week,6th month, 1st year
Surface luster of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Evaluation the Changes of Retention
Time frame: 1st day, 1st week,6th month, 1st year
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
Time frame: 1st day, 1st week,6th month, 1st year
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
Time frame: 1st day, 1st week, 6th month, 1st year
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
Time frame: 1st day, 1st week, 6th month, 1st year
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
Time frame: 1st day, 1st week, 6th month, 1st year
Marginal adaptation of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Evaluation the Changes of Wear
Time frame: 1st day, 1st week, 6th month, 1st year
Wear of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Evaluation the Changes of Patients View
Time frame: 1st day, 1st week, 6th month, 1st year
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
Time frame: 1st day, 1st week, 6th month, 1st year
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
Time frame: 1st day, 1st week, 6th month, 1st year
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
Time frame: 1st day, 1st week, 6th month, 1st year
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
Time frame: 1st day, 1st week, 6th month, 1st year
Periodontal response of the restorations will be evaluated and scored according to the FDI Direct Restorations Clinical Criteria Scale.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Results publication: PubMed 30206572Celik 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 publication: PubMed 30120605Celik 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Etching and Phosphoric acid etching in people with Dental Erosion, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation the Changes of Surface Luster (time frame: 1st day, 1st week,6th month, 1st year). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04095520, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2022.