TherapeuticsNCT05480852
Clinical Performance of BIS-GMA Free Dental Resin Composite
A study testing Bis-GMA Free dental resin composite in people with Therapeutics, run by Minia University at 1 site in Egypt.
Trial summary
Resin composites were introduced for restoring defective teeth commercially in the mid- 1960s as an alternative to acrylic resin and silicate cements. As one of the most significant contributions to dentistry, dental resin composites usually have three components as organic resin matrix, photo initiator system, and… Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Therapeutics
- What is being tested?
- Bis-GMA Free dental resin composite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2021to 6 Jul 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have been from 20 to 45 years of age.
- Have at least two molars supported permanent dentition free of any clinically significant occlusal interference who required class I or class II restoration and fulfilled the inclusion criteria, will informed about the study and will give a patient information leaflet (PIL) describing their potential involvement.
- The two studied materials restorations should be used in approximately the same sized lesions or within the same extension.
- The patient will be reimbursed for attending for the clinical evaluation(s) of their restorations.
- Be a regular dental attender who agree to return for assessments.
Who cannot join
- There was a history of any adverse reaction to clinical materials of the type to be used in the study.
- There was evidence of occlusal parafunction and/or pathological tooth wear.
- patients whose history revealed parafunctional habits or use of medications that potentially could cause hyposalivation.
- They are pregnant or have medical and/or dental histories which could possibly complicate their attendance for the assessment of the restorations and/ or influence the behavior and performance of the restorations in the clinical service.
- They were irregular dental attenders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Performance of BIS-GMA Free Dental Resin Composite as Posterior Restoration: a Randomized Clinical Trial
Resin composites were introduced for restoring defective teeth commercially in the mid- 1960s as an alternative to acrylic resin and silicate cements. As one of the most significant contributions to dentistry, dental resin composites usually have three components as organic resin matrix, photo initiator system, and coupling agent treated inorganic fillers.
At present, the most commonly used organic resin matrix for dental resin composites are based on di-methacrrylates such as 2.2- bis [p-(2- hydroxy-3- methacryloxypropoxy) penylene] propane (Bis-GMA), ethoxylated bisGMA, 1,6-bis(2-methacryloyoxy-ethoxycarbonyl-amino)-2,4,4tri-methyl-hexane (UDMA) and triethyleneglycoldimethacrylate (TEGDMA).
The application of Bis-GMA has been doubted since it was reported to have estrogenic activity in a cell culture assay.Though later studies have showed that Bis-GMA does not hydrolyse into the estrogenic substance BPA, BPA has still been detected to be release out of several commercial Bis-GMA-based dental restorative materials. Although there is a lack of studies analysing the association between BPA exposure from dental materials and its adverse effects on human health, there is a need to develop newer BPA-free resin composites to minimize human exposure to this compound. Accordingly, the objective of this study was to evaluate the performance of BIS- GMA- free composite as a photopolymerizable posterior dental composite restoration.
Read the detailed description
Hypothesis: The null hypothesis is that there is no difference in using the new BIS- GMA- free composite.
Aim of the study: This clinical trial was conducted to compare the clinical performance of the new BIS- GMA- free composite versus BIS-GMA- containing composite in the management of carious lesion in adult patients over 9 months. The two types of composites will be evaluated using USPHS criteria for:
- Retention (R).
- Contact (C).
- Color match (CM).
- Marginal adaptation (MA).
- Marginal discoloration (MD).
- Anatomic form (AF).
- Secondary caries (SC).
- Surface texture (ST).
- Gingival inflammation (GI).
- Post-operative sensitivity (POS).
- Patient complaints (PC).
- Patient satisfaction (PS).
- The evaluation done by three calibrated operators.
The study was conducted in Operative Dentistry Department, Faculty of Dentistry, Menia University.
The researcher was bear ultimate responsibility for all activities associated with the conduct of a research project including recruitment of patients, explaining, and performing the procedures to them.
- Intervention:
BIS- GMA- free composite material:
Tooth preparation and restoration was carried out using magnifying loops. All cavities were restored using composite resin. cavities, including the dentin, were acid etched for 30 s, rinsed thoroughly for 15 s, bonded with universal adhesive and light cured for 10 s prior to placing the filling material.
Restorations were light cured for 20 s, check the occlusion, finished with diamond burs and polished with Kenda hybrid composite pre- and super-polishers (Kenda, Vaduz, Liechtenstein).
- Comparator:
BIS- GMA- containing composite material:
The same methodology of the intervention BIS-GMA- free composite material If the patient showed any complications during our clinical trial toward either the intervention (BIS- GMA- free composite) or the comparator (BIS-GMA containing composite material), the trial will be stopped at once and all the needed management against any complications will be done.
- Conditions
- Therapeutics
- Being tested
- Bis-GMA Free dental resin composite
- Keywords
- Bis-GMA free dental resin composite, Bis-GMA containing dental resin composite, Clinical performance, Modified US Public Health Service Clinical Criteria (USPHS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bis-GMA Free dental resin compositeOther
Restorative Material
| Study group | Role | What they receive |
|---|---|---|
| Bis-GMA Free dental resin composite | Experimental | Restorative Materials Receives: Other: Bis-GMA Free dental resin composite |
| Bis-GMA containing dental resin composite | Active comparator | Restorative Materials Receives: Other: Bis-GMA Free dental resin composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the performance of BIS- GMA- free composite as a photopolymerizable posterior dental composite restoration versus BIS-GMA containing composite.
This clinical trial conducted to compare the clinical performance of the new BIS- GMA- free composite versus BIS-GMA- containing composite in the management of carious lesion in adult patients over 9 months. The two types of composites will be evaluated using USPHS criteria
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start20 May 2021
- Primary completion15 Jun 2022
- Study completion6 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TherapeuticsStudies of the same condition, open and under way.
- More trials run by Minia 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Ahmed Reda Mohamed, Minia University
- Investigators
- Sara A Reda, Phd, Principal investigator, Faculty of Dentistry, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05480852
- Sponsor's protocol ID
- Faculty of Dentistry
- Status last verified
- Jul 2022
- First submitted
- 26 Jul 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Reda SA, Hussein YF, Riad M. The impact of Bis-GMA free and Bis-GMA containing resin composite as posterior restoration on marginal integrity: a randomized controlled clinical trial. BMC Oral Health. 2023 Dec 19;23(1):1022. doi: 10.1186/s12903-023-03759-5.
PubMed 38114979
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of BIS-GMA Free Dental Resin Composite as Posterior Restoration: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05480852
- Acronym / sponsor ID
- Faculty of Dentistry
- Conditions
- Therapeutics
- Keywords
- Bis-GMA free dental resin composite, Bis-GMA containing dental resin composite, Clinical performance, Modified US Public Health Service Clinical Criteria (USPHS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 6 Jul 2022 (actual)
- First posted
- 29 Jul 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.
Resin composites were introduced for restoring defective teeth commercially in the mid- 1960s as an alternative to acrylic resin and silicate cements. As one of the most significant contributions to dentistry, dental resin composites usually have three components as organic resin matrix, photo initiator system, and coupling agent treated inorganic fillers.
At present, the most commonly used organic resin matrix for dental resin composites are based on di-methacrrylates such as 2.2- bis [p-(2- hydroxy-3- methacryloxypropoxy) penylene] propane (Bis-GMA), ethoxylated bisGMA, 1,6-bis(2-methacryloyoxy-ethoxycarbonyl-amino)-2,4,4tri-methyl-hexane (UDMA) and triethyleneglycoldimethacrylate (TEGDMA).
The application of Bis-GMA has been doubted since it was reported to have estrogenic activity in a cell culture assay.Though later studies have showed that Bis-GMA does not hydrolyse into the estrogenic substance BPA, BPA has still been detected to be release out of several commercial Bis-GMA-based dental restorative materials. Although there is a lack of studies analysing the association between BPA exposure from dental materials and its adverse effects on human health, there is a need to develop newer BPA-free resin composites to minimize human exposure to this compound. Accordingly, the objective of this study was to evaluate the performance of BIS- GMA- free composite as a photopolymerizable posterior dental composite restoration.
Detailed description
Hypothesis: The null hypothesis is that there is no difference in using the new BIS- GMA- free composite.
Aim of the study: This clinical trial was conducted to compare the clinical performance of the new BIS- GMA- free composite versus BIS-GMA- containing composite in the management of carious lesion in adult patients over 9 months. The two types of composites will be evaluated using USPHS criteria for:
- Retention (R).
- Contact (C).
- Color match (CM).
- Marginal adaptation (MA).
- Marginal discoloration (MD).
- Anatomic form (AF).
- Secondary caries (SC).
- Surface texture (ST).
- Gingival inflammation (GI).
- Post-operative sensitivity (POS).
- Patient complaints (PC).
- Patient satisfaction (PS).
- The evaluation done by three calibrated operators.
The study was conducted in Operative Dentistry Department, Faculty of Dentistry, Menia University.
The researcher was bear ultimate responsibility for all activities associated with the conduct of a research project including recruitment of patients, explaining, and performing the procedures to them.
- Intervention:
BIS- GMA- free composite material:
Tooth preparation and restoration was carried out using magnifying loops. All cavities were restored using composite resin. cavities, including the dentin, were acid etched for 30 s, rinsed thoroughly for 15 s, bonded with universal adhesive and light cured for 10 s prior to placing the filling material.
Restorations were light cured for 20 s, check the occlusion, finished with diamond burs and polished with Kenda hybrid composite pre- and super-polishers (Kenda, Vaduz, Liechtenstein).
- Comparator:
BIS- GMA- containing composite material:
The same methodology of the intervention BIS-GMA- free composite material If the patient showed any complications during our clinical trial toward either the intervention (BIS- GMA- free composite) or the comparator (BIS-GMA containing composite material), the trial will be stopped at once and all the needed management against any complications will be done.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bis-GMA Free dental resin composite | Experimental | Other: Bis-GMA Free dental resin compositeRestorative Materials |
| Bis-GMA containing dental resin composite | Active comparator | Other: Bis-GMA Free dental resin compositeRestorative Materials |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Have been from 20 to 45 years of age.
- Have at least two molars supported permanent dentition free of any clinically significant occlusal interference who required class I or class II restoration and fulfilled the inclusion criteria, will informed about the study and will give a patient information leaflet (PIL) describing their potential involvement.
- The two studied materials restorations should be used in approximately the same sized lesions or within the same extension.
- The patient will be reimbursed for attending for the clinical evaluation(s) of their restorations.
- Be a regular dental attender who agree to return for assessments.
Key exclusion criteria (5 listed)
- There was a history of any adverse reaction to clinical materials of the type to be used in the study.
- There was evidence of occlusal parafunction and/or pathological tooth wear.
- patients whose history revealed parafunctional habits or use of medications that potentially could cause hyposalivation.
- They are pregnant or have medical and/or dental histories which could possibly complicate their attendance for the assessment of the restorations and/ or influence the behavior and performance of the restorations in the clinical service.
- They were irregular dental attenders.
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 |
|---|---|---|
| Bis-GMA Free dental resin compositeRestorative Material | Other | Bis-GMA Free dental resin composite, Bis-GMA containing dental resin composite |
Primary outcome
Evaluate the performance of BIS- GMA- free composite as a photopolymerizable posterior dental composite restoration versus BIS-GMA containing composite.
Time frame: 9 months
This clinical trial conducted to compare the clinical performance of the new BIS- GMA- free composite versus BIS-GMA- containing composite in the management of carious lesion in adult patients over 9 months. The two types of composites will be evaluated using USPHS criteria
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 29 Jul 2022.
- Derived from this study: PubMed 38114979Reda SA, Hussein YF, Riad M. The impact of Bis-GMA free and Bis-GMA containing resin composite as posterior restoration on marginal integrity: a randomized controlled clinical trial. BMC Oral Health. 2023 Dec 19;23(1):1022. doi: 10.1186/s12903-023-03759-5.
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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.
Sara A Reda, Phd principal investigator
Faculty of Dentistry, Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bis-GMA Free dental resin composite in people with Therapeutics, run by Minia University at 1 site in Egypt.
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 29 Jul 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 Egypt. 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?
Evaluate the performance of BIS- GMA- free composite as a photopolymerizable posterior dental composite restoration versus BIS-GMA containing composite. (time frame: 9 months). 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 NCT05480852, which also lists 1 linked publication.
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 29 Jul 2022.