Caries, DentalNCT06601972
Partial Caries Removal in Permanent Molars Restored Using Giomer
A study testing Beautifil II LS (Low-Shrinkage) and Nanohybrid resin composite in people with Caries, Dental, run by NewGiza University.
Trial summary
Dental manufacturers\' constant tweaks and improvements to composite compositions have resulted in a wider spectrum of restorative materials with positive long-term clinical performance. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Caries, Dental
- What is being tested?
- Beautifil II LS (Low-Shrinkage) and Nanohybrid resin composite
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Inclusion criteria of participants:
- 18 -35 years.
- Not received antibiotic therapy since 1 month before sampling.
- Males or Females (Both genders).
- Co-operative patients approving the trial.
- Good to fair oral hygiene
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- Inclusion criteria of teeth:
- Class I cavitated lesions in permanent molars (reaching \>1/2 of the dentin on radiographic examination)
- Absence of spontaneous pain; negative sensitivity to percussion; and absence of periapical lesions (radiographic examination).
Who cannot join
- Exclusion criteria of participants:
- known allergic reaction to resinous materials.
- Systemic disease or severe medical complications.
- Periodontal problem.
- Bruxism
- Poor oral hygiene
Show all 11Show fewer
- Exclusion criteria of teeth:
- Class II caries lesion
- Shallow or enamel caries
- Teeth with periapical lesions.
- Mobile teeth, arrest caries and non-vital teeth
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical and Radiographic Evaluation of Partial Caries Removal in Permanent Molars Restored Using Giomer Compared to Resin Composite Restorations After 24 Months (A Randomized Clinical Trial)
Dental manufacturers\' constant tweaks and improvements to composite compositions have resulted in a wider spectrum of restorative materials with positive long-term clinical performance. For example, the creation of bioactive giomer material with proven continuous multi-ion release has been beneficial in avoiding demineralization and imparting acid resistance to enamel and dentin.
Read the detailed description
Giomer resin not only reduces the risk of secondary caries around restorations by releasing fluoride ions, but it also has good esthetic, physical, and handling features. Furthermore, advancements have been made to reduce giomer resin polymerization shrinkage by incorporating filler technology into the matrix system. As a result of these efforts, giomer resin is currently distinguished by its low shrinkage feature. According to the manufacturer, low shrinkage giomer resin has volumetric shrinkage of 0.8% and a polymerization shrinkage stress of 2.72 MPa. Several investigations were carried out to examine the overall clinical performance of low shrinkage giomer resin with equivalent success rates when compared to other restorative materials. The aim of the current study is to evaluate the effect of giomer in maintaining pulp health and dentin bridge formation after partial caries removal in permanent teeth with deep occlusal carious lesion when compared to resin composite restoration.
- Conditions
- Caries, Dental
- Being tested
- Beautifil II LS (Low-Shrinkage), Nanohybrid resin composite
- Keywords
- partial caries removal, bioactive, giomer
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beautifil II LS (Low-Shrinkage)Procedure or surgery
The most remarkable feature of this light-cured universal composite for anterior and posterior restorations is its unique shrinkage of 0.85 percent by volume
Nanohybrid resin compositeProcedure or surgery
Nanohybrid resin composites are the most popular, because they improve the distribution of fillers in the matrix by combining nanoparticles with submicron particles to achieve better mechanical, chemical, and optical properties
| Study group | Role | What they receive |
|---|---|---|
| Giomer | Experimental | Low-shrinkage bioactive material Receives: Procedure: Beautifil II LS (Low-Shrinkage) |
| Nanohybrid composite | Active comparator | Universal Nano-hybrid composite Receives: Procedure: Nanohybrid resin composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
The primary outcome of the present clinical trial is success rate, expressed as a binary variable indicating whether the restored tooth maintained its pulp vitality after 24 months. Success will be evaluated by a positive response to cold pulp testing, absence of spontaneous pain, no tenderness to percussion, absence of periapical radiolucency.
Measured: From enrollment to the end of treatment at 24 months
Secondary outcomes (1)
Dentin bridge formation
Dentin bridge formation will be evaluated by digital radiographs taken with standardized exposure parameters according to standardized procedure by placement of film holders in paralleling technique. Dentin bridge formation will be measured by millimeters (mm)
Measured: From enrollment to the end of treatment at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries, DentalStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NewGiza University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Shaalan, NewGiza University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601972
- Sponsor's protocol ID
- giomervscomp
- Status last verified
- Sep 2024
- First submitted
- 16 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: confidentiality, risk of data misinterpretation
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Partial Caries Removal in Permanent Molars Restored Using Giomer Compared to Resin Composite Restorations After 24 Months (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06601972
- Acronym / sponsor ID
- giomervscomp
- Conditions
- Caries, Dental
- Keywords
- partial caries removal, bioactive, giomer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- NewGiza UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
Dental manufacturers\' constant tweaks and improvements to composite compositions have resulted in a wider spectrum of restorative materials with positive long-term clinical performance. For example, the creation of bioactive giomer material with proven continuous multi-ion release has been beneficial in avoiding demineralization and imparting acid resistance to enamel and dentin.
Detailed description
Giomer resin not only reduces the risk of secondary caries around restorations by releasing fluoride ions, but it also has good esthetic, physical, and handling features. Furthermore, advancements have been made to reduce giomer resin polymerization shrinkage by incorporating filler technology into the matrix system. As a result of these efforts, giomer resin is currently distinguished by its low shrinkage feature. According to the manufacturer, low shrinkage giomer resin has volumetric shrinkage of 0.8% and a polymerization shrinkage stress of 2.72 MPa. Several investigations were carried out to examine the overall clinical performance of low shrinkage giomer resin with equivalent success rates when compared to other restorative materials. The aim of the current study is to evaluate the effect of giomer in maintaining pulp health and dentin bridge formation after partial caries removal in permanent teeth with deep occlusal carious lesion when compared to resin composite restoration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Giomer | Experimental | Procedure: Beautifil II LS (Low-Shrinkage)Low-shrinkage bioactive material |
| Nanohybrid composite | Active comparator | Procedure: Nanohybrid resin compositeUniversal Nano-hybrid composite |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Inclusion criteria of participants:
- Inclusion criteria of teeth:
Key exclusion criteria (11 listed)
- Exclusion criteria of participants:
- Exclusion criteria of teeth:
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 |
|---|---|---|
| Beautifil II LS (Low-Shrinkage)The most remarkable feature of this light-cured universal composite for anterior and posterior restorations is its unique shrinkage of 0.85 percent by volume | Procedure or surgery | Giomer |
| Nanohybrid resin compositeNanohybrid resin composites are the most popular, because they improve the distribution of fillers in the matrix by combining nanoparticles with submicron particles to achieve better mechanical, chemical, and optical properties | Procedure or surgery | Nanohybrid composite |
Primary outcome
Success rate
Time frame: From enrollment to the end of treatment at 24 months
The primary outcome of the present clinical trial is success rate, expressed as a binary variable indicating whether the restored tooth maintained its pulp vitality after 24 months. Success will be evaluated by a positive response to cold pulp testing, absence of spontaneous pain, no tenderness to percussion, absence of periapical radiolucency.
1 secondary outcome
Dentin bridge formation
Time frame: From enrollment to the end of treatment at 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. confidentiality, risk of data misinterpretation
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Beautifil II LS (Low-Shrinkage) and Nanohybrid resin composite in people with Caries, Dental, run by NewGiza 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 9 inclusion and 11 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: opening soon, as of the sponsor's last update on 19 Sep 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omar O Shaalan, PhD (+201122665661, omar.shaalan@ngu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate (time frame: From enrollment to the end of treatment at 24 months). 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 19 Sep 2024.