Dental Caries in ChildrenNCT05583682
Clinical Performance of Resin-modified Glass Ionomer and Composite Restorations in Permanent Teeth
A study testing Dental restoration in people with Dental Caries in Children, run by Hacinlioglu, Nadya Marie.
Trial summary
The aim of this randomised controlled double-blinded, split mouth, single-center clinical trial was to evaluate the 18-month clinical performance of nano-filled resin-modified glass ionomer and sub-micron hybrid resin composite restorations in lower first permanent teeth of pediatric patients. Read more about this study
- Who is it for?
- Ages 7 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- Dental restoration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2008to 1 Nov 2009
- 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 7 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients with two comparable occlusal carious lesions on both mandibular first permanent molars.
- Neutral occlusion with a natural antagonist tooth
- Patients that are able to come to recalls
- Patients with a good oral hygiene
Who cannot join
- Patients suffering systemic diseases or allergies
- Patients with gastrointestinal problems
- Mandibular first molar teeth with restorations
- Patients with oral habits
- Patients receiving orthodontic treatment
- Hypomineralized or Hypoplastic first molars
About this study
Official title: Clinical Performance of Nano-filled Resin-modified Glass Ionomer and Sub-micron Hybrid Resin Composite Restorations in Permanent Molar Teeth:18-month Randomised Clinical Trial
The aim of this randomised controlled double-blinded, split mouth, single-center clinical trial was to evaluate the 18-month clinical performance of nano-filled resin-modified glass ionomer and sub-micron hybrid resin composite restorations in lower first permanent teeth of pediatric patients.
Read the detailed description
Occlusal carious lesions on the left and right mandibular first molar teeth of 96 pediatric patients (54 female, 42 male) were restored in a split-mouth study design. Nano-filled resin-modified glass ionomer (Nano-RMGIC) (Ketac N 100, 3M/ESPE, USA) was used to restore the carious lesions for patients in the treatment group while a sub-micron hybrid resin composite (SpectrumTPH3, Dentsply, USA) was used for patients in the control group. Clinical evaluation of restorations were performed at the 1st week, 6th, 12th and 18th month recalls by two calibrated examiners according to the Modified-USPHS criteria.
- Conditions
- Dental Caries in Children
- Being tested
- Dental restoration
- Keywords
- nano-filled resin-modified glass ionomer, sub-micron hybrid resin composite, permanent molar teeth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental restorationOther
Restoration of carious mandibular first molar teeth are restored either with nano-filled resin modified glass ionomer or sub-micron resin composite restorative material
| Study group | Role | What they receive |
|---|---|---|
| Nano-filled resin-modified glass ionomer restoration | Experimental | One of the carious mandibular first molar teeth will be restored according to randomisation with nano-filled resin-modified glass ionomer restorative material (Ketac N 100/3M ESPE, USA) Receives: Other: Dental restoration |
| Sub-micron hybrid resin composite | Experimental | One of the carious mandibular first molar teeth will be restored according to randomisation with sub-micron hybrid resin composite restorative material (Spectrum TPH3, Dentsply Caulk, USA) Receives: Other: Dental restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Color Match
Color match of dental restorations were observed with a Vita Scale visually by two calibrated examiners. Restorations were scored Alfa, Bravo or Charlie according to Modified USPHS criteria. ( Alfa: Imperceptible in room light in one-second glance, Bravo: Perceptible mismatch with the Vita scale but clinically acceptable, Charlie: Esthetically unacceptable)
Measured: Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.
Marginal Discoloration
Marginal discoloration of dental restorations were observed by two calibrated examiners with visual inspection. Restorations were scored Alfa, Bravo or Charlie according to Modified USPHS criteria. (Alfa: No existing marginal discoloration, Bravo:Presence of discoloration at margins between restoration and tooth structure; discoloration does not penetrate towards the pulp, Charlie: The discoloration penetrated along the margins of the restoration in a pulpal direction.
Measured: Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.
Anatomic Form
Anatomic form of dental restorations were observed by two calibrated examiners by visual inspection and explorer. Restorations were scored Alfa, Bravo or Charlie according to Modified USPHS criteria. (Alfa: The restoration is not under-contoured, Bravo: The restoration is under-contoured, but there is no dentin or base exposed, Charlie: Sufficient restorative material is missing so that dentin or base is exposed.
Measured: Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.
Marginal Integrity
Marginal integrity of dental restorations were observed by two calibrated examiners with visual inspection and explorer. Restorations were scored Alfa, Bravo or Charlie according to Modified USPHS criteria. (Alfa: No visible evidence of a crevice along the margin into which an explorer will catch, Bravo: The explorer catches a crevice along the margin but there is no exposure of dentin or base, Charlie: Visible evidence of a crevice with exposure of dentin or base.)
Measured: Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.
Recurrent Decay
Recurrent decay of dental restorations were observed by two calibrated examiners with visual inspection. Restorations were scored Alfa or Charlie according to Modified USPHS criteria. (Alfa: No evidence of recurrent caries along the margin of the restoration, Charlie: Evidence of caries along the margin of the restoration.)
Measured: Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.
Fracture
Fracture of dental restorations were observed by two calibrated examiners by visual inspection with explorer. Restorations were scored Alfa, Bravo or Charlie according to Modified USPHS criteria. (Alfa: No fracture, Bravo: Small chip, but clinically acceptable, Charlie: Failure due to bulk restoration fracture.)
Measured: Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.
Surface Texture
Surface texture of dental restorations were observed by two calibrated examiners by visual inspection and explorer. Restorations were scored Alfa, Bravo or Charlie according to Modified USPHS criteria. (Alfa: Enamel like surface, Bravo: Surface rougher then enamel, clinically acceptable, Charlie: Surface unacceptable rough.)
Measured: Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.
Postoperative Sensitivity
Postoperative sensitivity of patients were assessed by two calibrated examiners by cold thermal test. Restorations were scored Alfa or Charlie according to Modified USPHS criteria. (Alfa: No sensitivity, Charlie: Sensitivity present.)
Measured: Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start1 May 2008
- Primary completion1 Nov 2009
- Study completion1 Nov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries in ChildrenStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One of the Nano-filled glass ionomer or sub-micron hybrid resin composite restorative materials were applied to carious mandibular first molar teeth
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacinlioglu, Nadya Marie
- Sponsor type
- University, hospital or other
- Collaborators
- Yeditepe University
- Responsible party
- Principal investigator, Nadya Marie Hacinlioglu, Hacinlioglu, Nadya Marie
- Investigators
- Nadya M Hacinlioglu-Ozpar, PhD, Principal investigator, Cyprus Health and Social Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583682
- Sponsor's protocol ID
- RCT1103200802
- Status last verified
- Oct 2022
- First submitted
- 12 Oct 2022
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Nano-filled Resin-modified Glass Ionomer and Sub-micron Hybrid Resin Composite Restorations in Permanent Molar Teeth:18-month Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT05583682
- Acronym / sponsor ID
- RCT1103200802
- Conditions
- Dental Caries in Children
- Keywords
- nano-filled resin-modified glass ionomer, sub-micron hybrid resin composite, permanent molar teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Hacinlioglu, Nadya MarieUniversity, hospital or other
- Collaborators
- Yeditepe University
- Study start
- 1 May 2008 (actual)
- Primary completion
- 1 Nov 2009 (actual)
- Study completion
- 1 Nov 2009 (actual)
- First posted
- 18 Oct 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 randomised controlled double-blinded, split mouth, single-center clinical trial was to evaluate the 18-month clinical performance of nano-filled resin-modified glass ionomer and sub-micron hybrid resin composite restorations in lower first permanent teeth of pediatric patients.
Detailed description
Occlusal carious lesions on the left and right mandibular first molar teeth of 96 pediatric patients (54 female, 42 male) were restored in a split-mouth study design. Nano-filled resin-modified glass ionomer (Nano-RMGIC) (Ketac N 100, 3M/ESPE, USA) was used to restore the carious lesions for patients in the treatment group while a sub-micron hybrid resin composite (SpectrumTPH3, Dentsply, USA) was used for patients in the control group. Clinical evaluation of restorations were performed at the 1st week, 6th, 12th and 18th month recalls by two calibrated examiners according to the Modified-USPHS criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- One of the Nano-filled glass ionomer or sub-micron hybrid resin composite restorative materials were applied to carious mandibular first molar teeth
| Arm | Type | Receives |
|---|---|---|
| Nano-filled resin-modified glass ionomer restoration | Experimental | Other: Dental restorationOne of the carious mandibular first molar teeth will be restored according to randomisation with nano-filled resin-modified glass ionomer restorative material (Ketac N 100/3M ESPE, USA) |
| Sub-micron hybrid resin composite | Experimental | Other: Dental restorationOne of the carious mandibular first molar teeth will be restored according to randomisation with sub-micron hybrid resin composite restorative material (Spectrum TPH3, Dentsply Caulk, USA) |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients with two comparable occlusal carious lesions on both mandibular first permanent molars.
- Neutral occlusion with a natural antagonist tooth
- Patients that are able to come to recalls
- Patients with a good oral hygiene
Key exclusion criteria (6 listed)
- Patients suffering systemic diseases or allergies
- Patients with gastrointestinal problems
- Mandibular first molar teeth with restorations
- Patients with oral habits
- Patients receiving 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 |
|---|---|---|
| Dental restorationRestoration of carious mandibular first molar teeth are restored either with nano-filled resin modified glass ionomer or sub-micron resin composite restorative material | Other | Nano-filled resin-modified glass ionomer restoration, Sub-micron hybrid resin composite |
Primary outcome
Color Match
Time frame: Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.
Color match of dental restorations were observed with a Vita Scale visually by two calibrated examiners. Restorations were scored Alfa, Bravo or Charlie according to Modified USPHS criteria. ( Alfa: Imperceptible in room light in one-second glance, Bravo: Perceptible mismatch with the Vita scale but clinically acceptable, Charlie: Esthetically unacceptable)
Marginal Discoloration
Time frame: Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.
Marginal discoloration of dental restorations were observed by two calibrated examiners with visual inspection. Restorations were scored Alfa, Bravo or Charlie according to Modified USPHS criteria. (Alfa: No existing marginal discoloration, Bravo:Presence of discoloration at margins between restoration and tooth structure; discoloration does not penetrate towards the pulp, Charlie: The discoloration penetrated along the margins of the restoration in a pulpal direction.
Anatomic Form
Time frame: Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.
Anatomic form of dental restorations were observed by two calibrated examiners by visual inspection and explorer. Restorations were scored Alfa, Bravo or Charlie according to Modified USPHS criteria. (Alfa: The restoration is not under-contoured, Bravo: The restoration is under-contoured, but there is no dentin or base exposed, Charlie: Sufficient restorative material is missing so that dentin or base is exposed.
Marginal Integrity
Time frame: Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.
Marginal integrity of dental restorations were observed by two calibrated examiners with visual inspection and explorer. Restorations were scored Alfa, Bravo or Charlie according to Modified USPHS criteria. (Alfa: No visible evidence of a crevice along the margin into which an explorer will catch, Bravo: The explorer catches a crevice along the margin but there is no exposure of dentin or base, Charlie: Visible evidence of a crevice with exposure of dentin or base.)
Recurrent Decay
Time frame: Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.
Recurrent decay of dental restorations were observed by two calibrated examiners with visual inspection. Restorations were scored Alfa or Charlie according to Modified USPHS criteria. (Alfa: No evidence of recurrent caries along the margin of the restoration, Charlie: Evidence of caries along the margin of the restoration.)
Fracture
Time frame: Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.
Fracture of dental restorations were observed by two calibrated examiners by visual inspection with explorer. Restorations were scored Alfa, Bravo or Charlie according to Modified USPHS criteria. (Alfa: No fracture, Bravo: Small chip, but clinically acceptable, Charlie: Failure due to bulk restoration fracture.)
Surface Texture
Time frame: Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.
Surface texture of dental restorations were observed by two calibrated examiners by visual inspection and explorer. Restorations were scored Alfa, Bravo or Charlie according to Modified USPHS criteria. (Alfa: Enamel like surface, Bravo: Surface rougher then enamel, clinically acceptable, Charlie: Surface unacceptable rough.)
Postoperative Sensitivity
Time frame: Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.
Postoperative sensitivity of patients were assessed by two calibrated examiners by cold thermal test. Restorations were scored Alfa or Charlie according to Modified USPHS criteria. (Alfa: No sensitivity, Charlie: Sensitivity present.)
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 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Dental Caries in Children
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
This Feasibility Study Will Evaluate the Study Protocols for Treatment and Follow-up Controls of Primary Molars With Caries in Children Treated With Stainless Steel Crowns or Conventional Fillings. Treatment Success and Potential Failures Will be Followed at 3, 6 and 12 Months Post Treatment.
Dental Caries, Early Childhood Caries (ECC)
Recruiting
A Study to Evaluate the Cariostatic Efficacy of Nano Silver Fluoride (NSF) vs. Silver Diamine Fluoride (SDF) in Children
Dental Caries
Not yet recruiting
Effect of Bioactive Glass Varnish on Salivary Parameters in Children: Randomized Controlled Trial
Prevention of Dental Caries
Active, not recruiting
Luting Cements for Prefabricated Zirconia Crown Retention in Primary Anterior Teeth in Children
Dental Caries, Tooth Injuries
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.
Nadya M Hacinlioglu-Ozpar, PhD principal investigator
Cyprus Health and Social Sciences University
Questions about this trial
What is this clinical trial studying?
A study testing Dental restoration in people with Dental Caries in Children, run by Hacinlioglu, Nadya Marie.
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 6 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 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Color Match (time frame: Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.). The study lists 8 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 18 Oct 2022.