Dental Restoration Failure of Marginal IntegrityNCT05551130
Could Bulk Fill Glass Hybrid Restorative Materials Replace Composite Resins in Treating Permanent Teeth?
A study testing Restoration in people with Dental Restoration Failure of Marginal Integrity, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the clinical and radiographic efficacy of Equia system bulk fill glass hybrid material with composite resins in the permanent restoration of pediatric patients' permanent teeth. Read more about this study
- Who is it for?
- Ages 8 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Restoration Failure of Marginal Integrity
- What is being tested?
- Restoration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2020to 1 Aug 2021
- 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 8 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The patient has no systemic disease
- The patient should have good periodontal status
- Teeth to be restored should be symptomless and vital
- Teeth to be restored should have proximal contacts on both mesial and distal surfaces and be in occlusion with the antagonist teeth
- Teeth that have class II caries lesions in external and middle 1/3 of dentine thickness radiographically
Who cannot join
- Xerostomia and bruxism;
- Absence of adjacent and antagonist teeth;
- Extremely poor oral hygiene, severe or chronic periodontitis;
- Teeth that have any restoration, endodontic treatment, periodontal and periapical pathology.
- The patients who are undergoing orthodontic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is There a Possibility That Bulk Fill Glass Hybrid Restorative Materials Could Replace Composite Resins in Treating Permanent Teeth? : A Randomized Controlled Clinical Trial
The aim of this study is to compare the clinical and radiographic efficacy of Equia system bulk fill glass hybrid material with composite resins in the permanent restoration of pediatric patients' permanent teeth.
Read the detailed description
The study included 44 pediatric patients aged 8 to 16 years who applied to the Pedodontics Department of the Necmettin Erbakan University Faculty of Dentistry. The groups were formed as symmetrical teeth in the same patient using the split-mouth design. The study included class I caries lesions of 144 permanent teeth, 72 of which were restored with the Equia system bulk fill glass hybrid material [Equia Forte HT+Equia Forte Coat (GC, Co, Tokyo, Japan)] and 72 with the Charisma Smart universal composite resin (Kulzer, Gmbh, Hanau, Germany) + Clearfil SE Bond (Kuraray, Noritake, Sakazu, Okayama). Evaluations were performed clinically and radiographically by 2 physicians in the 2nd week, 3rd month, 6th month, and 12th month and the results were recorded. Clinical evaluation was carried out using modified USPHS criteria. Obtained data were statistically analyzed using Kendall's W test and Cochran's Q test for the comparison within the group, and the Chi-Square test for the comparison between the groups.
- Being tested
- Restoration
- Keywords
- Composite Resins, Clinical Trial, Glass Ionomer Cements, Permanent Dental Restoration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RestorationOther
Also called Restorative Interventions
Restorations completed with these materials.
| Study group | Role | What they receive |
|---|---|---|
| Equia Group | Active comparator | Equia system bulk fill glass hybrid material Receives: Other: Restoration |
| Charisma Group | Active comparator | Charisma Smart universal composite resin Receives: Other: Restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
marginal adaptation
According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted.
The scale:
Alfa Bravo Charlie
Measured: 2 weeks-12 months
marginal discoloration
According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted.
The scale:
Alfa Bravo Charlie
Measured: 2 weeks-12 months
color match
According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted.
The scale:
Alfa Bravo Charlie
Measured: 2 weeks-12 months
surface texture
According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted.
The scale:
Alfa Bravo Charlie
Measured: 2 weeks-12 months
secondary caries
According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted.
The scale:
Alfa Bravo Charlie
Measured: 2 weeks-12 months
postoperative sensitivity
According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted.
The scale:
Alfa Bravo Charlie
Measured: 2 weeks-12 months
retention
According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted.
The scale:
Alfa Bravo Charlie
Measured: 2 weeks-12 months
Secondary outcomes (1)
anatomic form
According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted.
The scale:
Alfa Bravo Charlie
Measured: 2 weeks-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start1 Aug 2020
- Primary completion16 Aug 2020
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Restoration Failure of Marginal IntegrityStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hazal Özer, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551130
- Sponsor's protocol ID
- 2020/332
- Status last verified
- Sep 2022
- First submitted
- 19 Sep 2022
- Last updated
- 26 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The research will be published soon.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There a Possibility That Bulk Fill Glass Hybrid Restorative Materials Could Replace Composite Resins in Treating Permanent Teeth? : A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05551130
- Acronym / sponsor ID
- 2020/332
- Keywords
- Composite Resins, Clinical Trial, Glass Ionomer Cements, Permanent Dental Restoration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 16 Aug 2020 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 22 Sep 2022 (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.
The aim of this study is to compare the clinical and radiographic efficacy of Equia system bulk fill glass hybrid material with composite resins in the permanent restoration of pediatric patients' permanent teeth.
Detailed description
The study included 44 pediatric patients aged 8 to 16 years who applied to the Pedodontics Department of the Necmettin Erbakan University Faculty of Dentistry. The groups were formed as symmetrical teeth in the same patient using the split-mouth design. The study included class I caries lesions of 144 permanent teeth, 72 of which were restored with the Equia system bulk fill glass hybrid material [Equia Forte HT+Equia Forte Coat (GC, Co, Tokyo, Japan)] and 72 with the Charisma Smart universal composite resin (Kulzer, Gmbh, Hanau, Germany) + Clearfil SE Bond (Kuraray, Noritake, Sakazu, Okayama). Evaluations were performed clinically and radiographically by 2 physicians in the 2nd week, 3rd month, 6th month, and 12th month and the results were recorded. Clinical evaluation was carried out using modified USPHS criteria. Obtained data were statistically analyzed using Kendall's W test and Cochran's Q test for the comparison within the group, and the Chi-Square test for the comparison between the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Equia Group | Active comparator | Other: RestorationEquia system bulk fill glass hybrid material |
| Charisma Group | Active comparator | Other: RestorationCharisma Smart universal composite resin |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- The patient has no systemic disease
- The patient should have good periodontal status
- Teeth to be restored should be symptomless and vital
- Teeth to be restored should have proximal contacts on both mesial and distal surfaces and be in occlusion with the antagonist teeth
- Teeth that have class II caries lesions in external and middle 1/3 of dentine thickness radiographically
Key exclusion criteria (5 listed)
- Xerostomia and bruxism;
- Absence of adjacent and antagonist teeth;
- Extremely poor oral hygiene, severe or chronic periodontitis;
- Teeth that have any restoration, endodontic treatment, periodontal and periapical pathology.
- The patients who are undergoing orthodontic treatment
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 |
|---|---|---|
| RestorationAlso: Restorative InterventionsRestorations completed with these materials. | Other | Charisma Group, Equia Group |
Primary outcome
marginal adaptation
Time frame: 2 weeks-12 months
According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted. The scale: Alfa Bravo Charlie
marginal discoloration
Time frame: 2 weeks-12 months
According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted. The scale: Alfa Bravo Charlie
color match
Time frame: 2 weeks-12 months
According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted. The scale: Alfa Bravo Charlie
surface texture
Time frame: 2 weeks-12 months
According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted. The scale: Alfa Bravo Charlie
secondary caries
Time frame: 2 weeks-12 months
According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted. The scale: Alfa Bravo Charlie
postoperative sensitivity
Time frame: 2 weeks-12 months
According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted. The scale: Alfa Bravo Charlie
retention
Time frame: 2 weeks-12 months
According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted. The scale: Alfa Bravo Charlie
1 secondary outcome
anatomic form
Time frame: 2 weeks-12 months
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 26 Sep 2022.
- Individual participant dataSharing planned: No. The research will be published soon.
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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 Restoration in people with Dental Restoration Failure of Marginal Integrity, run by Necmettin Erbakan 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 5 inclusion and 5 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 26 Sep 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?
marginal adaptation (time frame: 2 weeks-12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2022.