Dental Caries Class IINCT03030690
A Clinical Assessment of Glass Carbomer Cement
A study testing Glass Carbomer Cement, Composite Resin and Resin Modified Glass Ionomer Cement in people with Dental Caries Class II, run by King Abdulaziz University.
Trial summary
This study will evaluate the clinical performance of glass carbomer cement restorations in restoring proximal lesions in primary molars compared to that of resin modified glass ionomer cement and composite resin restorations. Read more about this study
- Who is it for?
- Ages 4 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries Class II
- What is being tested?
- Glass Carbomer Cement, Composite Resin and Resin Modified Glass Ionomer Cement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Jan 2018
- 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 4 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- One proximal lesion in a primary molar.
- Radiographic evidence of caries extending at least into the inner half of the enamel but not the inner half of dentin.
- Proximal contact with adjacent healthy or restored teeth.
- Occlusal contact with opposing healthy or restored teeth.
- No indication for pulp therapy or other restorative treatment.
- A predicted survival until exfoliation of 2 years.
Who cannot join
- Radiographic evidence of caries extending into the inner half of dentin.
- No proximal contact with adjacent healthy or restored teeth.
- No occlusal contact with opposing healthy or restored teeth.
- Tooth indicated for pulp therapy or other restorative treatment.
- A predicted survival until exfoliation of less than 2 years.
About this study
Official title: A Clinical Assessment of Class II Glass Carbomer Cement Restorations Compared to Resin Modified Glass Ionomer Cement and Composite Resin Restorations in Primary Molars.
This study will evaluate the clinical performance of glass carbomer cement restorations in restoring proximal lesions in primary molars compared to that of resin modified glass ionomer cement and composite resin restorations. Teeth will be randomly assigned to one of the three restoration groups and the restorations will be evaluated clinically and radiographically every six months.
Read the detailed description
Glass Carbomer is a monomer free; carbomised nano-glass restorative cement developed from traditional glass ionomer cement (GIC) and contains nano-sized powder particles of hydroxyapatite and fluorapatite. These materials claim to have improved mechanical properties and better bonding to dentin, in addition to continues fluoride release.
The study is a randomized controlled clinical trial where teeth will be randomly assigned to one of the three restoration groups.
Following medical and dental history, bilateral bitewing radiographs will be taken for each patient to assess the presence of proximal lesions. Suitable teeth will then be randomly assigned to one of the restoration groups. A single operator using local anesthesia and rubber dam isolation will then prepare standardized Class II cavities and place the designated restorations according to the manufacturer's instructions.
The quality of the 3 types of restorations will be clinically evaluated at baseline and every six months for color match, marginal discoloration, anatomic form, marginal adaptation, and secondary caries using the criteria described by "Cvar and Ryge" (2005). The evaluation will be performed by 2 calibrated examiners.
Following placement of the restorations, bitewing radiographs will be taken to evaluate the restorations and will be repeated every six months for detection of recurrent caries.
- Conditions
- Dental Caries Class II
- Being tested
- Glass Carbomer Cement, Composite Resin, Resin Modified Glass Ionomer Cement
- Keywords
- Proximal Dental Caries, Glass Carbomer, Hydroxyapatite Enhanced Glass Ionomer, Primary Teeth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glass Carbomer CementOther
Also called GCP Glass Fill, Hydroxyapatite enhance glass ionomer cement
Restoration of proximal lesions in primary molars using glass carbomer cement
Composite ResinOther
Also called Filtek Z250
Restoration of proximal lesions in primary molars using composite resin.
Resin Modified Glass Ionomer CementOther
Also called GC Fuji II LC Capsule
Restoration of proximal lesions in primary molars using resin modified glass ionomer cement
| Study group | Role | What they receive |
|---|---|---|
| Glass Carbomer Cement | Experimental | GCP Glass Fill, Glass Carbomer™Tech, Ridderkerk, Netherlands Receives: Other: Glass Carbomer Cement |
| Resin Modified Glass Ionomer Cement | Active comparator | GC Fuji II LC Capsule, GC International, Tokyo, Japan Receives: Other: Resin Modified Glass Ionomer Cement |
| Composite Resin | Active comparator | Filtek Z250, 3M ESPE, St Paul, MN, USA Receives: Other: Composite Resin |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical success rate of glass carbomer cement in restoring proximal lesions in primary molars.
the clinical success of glass carbomer cement in restoring proximal lesions compared to the success of resin modified glass ionomer cement and composite resin.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study startNov 2016
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Dental Caries Class IIStudies 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
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sumaya Nouri, King Abdulaziz University
- Investigators
- Najlaa Alamoudi, MSc, DSc, Study chair, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03030690
- Sponsor's protocol ID
- 070-16
- Status last verified
- Mar 2018
- First submitted
- 21 Jan 2017
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Chen X, Du MQ, Fan MW, Mulder J, Huysmans MC, Frencken JE. Caries-preventive effect of sealants produced with altered glass-ionomer materials, after 2 years. Dent Mater. 2012 May;28(5):554-60. doi: 10.1016/j.dental.2012.01.001. Epub 2012 Jan 31.
PubMed 22300651Chen X, Du M, Fan M, Mulder J, Huysmans MC, Frencken JE. Effectiveness of two new types of sealants: retention after 2 years. Clin Oral Investig. 2012 Oct;16(5):1443-50. doi: 10.1007/s00784-011-0633-9. Epub 2011 Nov 29.
PubMed 22124610Cvar JF, Ryge G. Reprint of criteria for the clinical evaluation of dental restorative materials. 1971. Clin Oral Investig. 2005 Dec;9(4):215-32. doi: 10.1007/s00784-005-0018-z. No abstract available.
PubMed 16315023Gorseta K, Glavina D, Borzabadi-Farahani A, Van Duinen RN, Skrinjaric I, Hill RG, Lynch E. One-year clinical evaluation of a Glass Carbomer fissure sealant, a preliminary study. Eur J Prosthodont Restor Dent. 2014 Jun;22(2):67-71.
PubMed 25134364Gu YW, Yap AU, Cheang P, Khor KA. Effects of incorporation of HA/ZrO(2) into glass ionomer cement (GIC). Biomaterials. 2005 Mar;26(7):713-20. doi: 10.1016/j.biomaterials.2004.03.019.
PubMed 15350775Hubel S, Mejare I. Conventional versus resin-modified glass-ionomer cement for Class II restorations in primary molars. A 3-year clinical study. Int J Paediatr Dent. 2003 Jan;13(1):2-8. doi: 10.1046/j.1365-263x.2003.00416.x.
PubMed 12542617Lucas ME, Arita K, Nishino M. Toughness, bonding and fluoride-release properties of hydroxyapatite-added glass ionomer cement. Biomaterials. 2003 Sep;24(21):3787-94. doi: 10.1016/s0142-9612(03)00260-6.
PubMed 12818551Lucas ME, Arita K, Nishino M. Strengthening a conventional glass ionomer cement using hydroxyapatite. J Dent Res. 2001;80:711.
Moshaverinia A, Ansari S, Moshaverinia M, Roohpour N, Darr JA, Rehman I. Effects of incorporation of hydroxyapatite and fluoroapatite nanobioceramics into conventional glass ionomer cements (GIC). Acta Biomater. 2008 Mar;4(2):432-40. doi: 10.1016/j.actbio.2007.07.011. Epub 2007 Aug 25.
PubMed 17921077
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Assessment of Class II Glass Carbomer Cement Restorations Compared to Resin Modified Glass Ionomer Cement and Composite Resin Restorations in Primary Molars.
- ClinicalTrials.gov ID
- NCT03030690
- Acronym / sponsor ID
- 070-16
- Conditions
- Dental Caries Class II
- Keywords
- Proximal Dental Caries, Glass Carbomer, Hydroxyapatite Enhanced Glass Ionomer, Primary Teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 25 Jan 2017 (estimated)
- 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.
This study will evaluate the clinical performance of glass carbomer cement restorations in restoring proximal lesions in primary molars compared to that of resin modified glass ionomer cement and composite resin restorations. Teeth will be randomly assigned to one of the three restoration groups and the restorations will be evaluated clinically and radiographically every six months.
Detailed description
Glass Carbomer is a monomer free; carbomised nano-glass restorative cement developed from traditional glass ionomer cement (GIC) and contains nano-sized powder particles of hydroxyapatite and fluorapatite. These materials claim to have improved mechanical properties and better bonding to dentin, in addition to continues fluoride release.
The study is a randomized controlled clinical trial where teeth will be randomly assigned to one of the three restoration groups.
Following medical and dental history, bilateral bitewing radiographs will be taken for each patient to assess the presence of proximal lesions. Suitable teeth will then be randomly assigned to one of the restoration groups. A single operator using local anesthesia and rubber dam isolation will then prepare standardized Class II cavities and place the designated restorations according to the manufacturer's instructions.
The quality of the 3 types of restorations will be clinically evaluated at baseline and every six months for color match, marginal discoloration, anatomic form, marginal adaptation, and secondary caries using the criteria described by "Cvar and Ryge" (2005). The evaluation will be performed by 2 calibrated examiners.
Following placement of the restorations, bitewing radiographs will be taken to evaluate the restorations and will be repeated every six months for detection of recurrent caries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glass Carbomer Cement | Experimental | Other: Glass Carbomer CementGCP Glass Fill, Glass Carbomer™Tech, Ridderkerk, Netherlands |
| Resin Modified Glass Ionomer Cement | Active comparator | Other: Resin Modified Glass Ionomer CementGC Fuji II LC Capsule, GC International, Tokyo, Japan |
| Composite Resin | Active comparator | Other: Composite ResinFiltek Z250, 3M ESPE, St Paul, MN, USA |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- One proximal lesion in a primary molar.
- Radiographic evidence of caries extending at least into the inner half of the enamel but not the inner half of dentin.
- Proximal contact with adjacent healthy or restored teeth.
- Occlusal contact with opposing healthy or restored teeth.
- No indication for pulp therapy or other restorative treatment.
Key exclusion criteria (5 listed)
- Radiographic evidence of caries extending into the inner half of dentin.
- No proximal contact with adjacent healthy or restored teeth.
- No occlusal contact with opposing healthy or restored teeth.
- Tooth indicated for pulp therapy or other restorative treatment.
- A predicted survival until exfoliation of less than 2 years.
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 |
|---|---|---|
| Glass Carbomer CementAlso: GCP Glass Fill, Hydroxyapatite enhance glass ionomer cementRestoration of proximal lesions in primary molars using glass carbomer cement | Other | Glass Carbomer Cement |
| Composite ResinAlso: Filtek Z250Restoration of proximal lesions in primary molars using composite resin. | Other | Composite Resin |
| Resin Modified Glass Ionomer CementAlso: GC Fuji II LC CapsuleRestoration of proximal lesions in primary molars using resin modified glass ionomer cement | Other | Resin Modified Glass Ionomer Cement |
Primary outcome
clinical success rate of glass carbomer cement in restoring proximal lesions in primary molars.
Time frame: 2 Years
the clinical success of glass carbomer cement in restoring proximal lesions compared to the success of resin modified glass ionomer cement and composite resin.
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 7 Mar 2018.
- Background: PubMed 22300651Chen X, Du MQ, Fan MW, Mulder J, Huysmans MC, Frencken JE. Caries-preventive effect of sealants produced with altered glass-ionomer materials, after 2 years. Dent Mater. 2012 May;28(5):554-60. doi: 10.1016/j.dental.2012.01.001. Epub 2012 Jan 31.
- Background: PubMed 22124610Chen X, Du M, Fan M, Mulder J, Huysmans MC, Frencken JE. Effectiveness of two new types of sealants: retention after 2 years. Clin Oral Investig. 2012 Oct;16(5):1443-50. doi: 10.1007/s00784-011-0633-9. Epub 2011 Nov 29.
- Background: PubMed 16315023Cvar JF, Ryge G. Reprint of criteria for the clinical evaluation of dental restorative materials. 1971. Clin Oral Investig. 2005 Dec;9(4):215-32. doi: 10.1007/s00784-005-0018-z. No abstract available.
- Background: PubMed 25134364Gorseta K, Glavina D, Borzabadi-Farahani A, Van Duinen RN, Skrinjaric I, Hill RG, Lynch E. One-year clinical evaluation of a Glass Carbomer fissure sealant, a preliminary study. Eur J Prosthodont Restor Dent. 2014 Jun;22(2):67-71.
- Background: PubMed 15350775Gu YW, Yap AU, Cheang P, Khor KA. Effects of incorporation of HA/ZrO(2) into glass ionomer cement (GIC). Biomaterials. 2005 Mar;26(7):713-20. doi: 10.1016/j.biomaterials.2004.03.019.
- Background: PubMed 12542617Hubel S, Mejare I. Conventional versus resin-modified glass-ionomer cement for Class II restorations in primary molars. A 3-year clinical study. Int J Paediatr Dent. 2003 Jan;13(1):2-8. doi: 10.1046/j.1365-263x.2003.00416.x.
- Background: PubMed 12818551Lucas ME, Arita K, Nishino M. Toughness, bonding and fluoride-release properties of hydroxyapatite-added glass ionomer cement. Biomaterials. 2003 Sep;24(21):3787-94. doi: 10.1016/s0142-9612(03)00260-6.
- BackgroundLucas ME, Arita K, Nishino M. Strengthening a conventional glass ionomer cement using hydroxyapatite. J Dent Res. 2001;80:711.
- Background: PubMed 17921077Moshaverinia A, Ansari S, Moshaverinia M, Roohpour N, Darr JA, Rehman I. Effects of incorporation of hydroxyapatite and fluoroapatite nanobioceramics into conventional glass ionomer cements (GIC). Acta Biomater. 2008 Mar;4(2):432-40. doi: 10.1016/j.actbio.2007.07.011. Epub 2007 Aug 25.
- The longevity of dental restorations: a systematic review. Report 19, NHS Centre for Reviews and DisseminationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Najlaa Alamoudi, MSc, DSc study chair
King Abdulaziz University
Questions about this trial
What is this clinical trial studying?
A study testing Glass Carbomer Cement, Composite Resin and Resin Modified Glass Ionomer Cement in people with Dental Caries Class II, run by King Abdulaziz University.
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 6 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 7 Mar 2018. 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?
clinical success rate of glass carbomer cement in restoring proximal lesions in primary molars. (time frame: 2 Years). 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 NCT03030690, which also lists 9 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 7 Mar 2018.