Dental Caries Class vNCT05617703
Evaluation of Glass Ionomer With Advanced Glass Hybrid Technology Versus Resin Modified Glass Ionomer in Adult Patients With Carious Cervical Lesions After One Year
A study testing Glass Ionomer with Advanced Glass Hybrid Technology (Equia forte HT fil, GC, Japan) in people with Dental Caries Class v, run by Cairo University.
Trial summary
The goal of this [type of study: Randomized clinical trial] to compare the clinical performance of using glass ionomer with advanced glass hybrid technology (AGH) in cervical carious lesion, versus Resin modified glass ionomer (RMGI) using esthetic and mechanical properties according to FDI criteria over one year. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Caries Class v
- What is being tested?
- Glass Ionomer with Advanced Glass Hybrid Technology (Equia forte HT fil, GC, Japan)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Dec 2022to Dec 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient inclusion:
- Patients aging ≥18 years.
- Patients with High caries risk.
- Patients with untreated cervical caries lesion that need restorative treatment.
- Males or females
- No abnormal occlusion for selected teeth.
Show all 12Show fewer
- Patients with good likelihood of recall availability
- Tooth inclusion:
- Permanent teeth.
- Absence of mobility.
- Primary carious lesions.
- Vital with positive reaction to thermal stimulus .
Who cannot join
- 1. Participants with general/systemic illness. 2. Concomitant participation in another research study. 3. Inability to comply with study procedures. 4. Heavy bruxism habits. 5. Last experience with allergic reactions against any components of the used materials.
- 6. Patients receiving orthodontic treatment. 7. Teeth supporting removable prosthesis 8. Patients with cervical caries lesions that need crown restoration. 9. Xerostomia.
- Tooth exclusion:
- Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
- Non-vital teeth.
- Periapcal Abscess or Fistula.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Glass Ionomer With Advanced Glass Hybrid Technology Versus Resin Modified Glass Ionomer in Adult Patients With Carious Cervical Lesions After One Year: Randomized Clinical Trial
The goal of this [type of study: Randomized clinical trial] to compare the clinical performance of using glass ionomer with advanced glass hybrid technology (AGH) in cervical carious lesion, versus Resin modified glass ionomer (RMGI) using esthetic and mechanical properties according to FDI criteria over one year.
in adult patients with cervical carious lesion.
Read more
The main question it aims to answer are:
- Will the use of glass ionomer with advanced glass hybrid technology, achieved through introduction of ultra-fine highly reactive glass and high-molecular weight polyacrylic acid powders within conventional glass ,or Resin Modified Glass Ionomer have better mechanical and estheic properties over one year in adult patients with cervical carious lesions ?
Participants will be assessed for medical and dental histories first. Then an examination of the patients will be done using visual inspection by using a dental mirror and probe. Eligible patients according to inclusion and exclusion criteria will be informed about all procedures with follow up time if they accept, their signature on written informed consents will be obtained. Eligible participants will be randomly divided into two groups according to the type of restoration that will be received after class V cavity preparations for carious cervical lesions.
Patients will be given local anaesthesia (Mepecaine - L Cartridges) as required, and the teeth will be isolated. A No. #330 bur (MANI, INC, Japan) in a high-speed hand piece with air/water coolant will be used to prepare class V cavity. Sharp excavators of suitable size were used to excavate soft carious lesions in dentin. the prepared cavity will be isolated with rubber dam.
The first group (A) will be received resin modified glass ionomer restorative material and the second group (B) will be received advanced glass hybrid glass ionomer . Each restoration will be evaluated for clinical parameters after finishing and polishing at baseline and regular recalls of 6 months and one year. The restorations will be clinically examined according to FDI criteria criteria in terms of esthetic and mechanical properties . The information that will be obtained will be collected and statistically analyzed.
Read the detailed description
Eligibility criteria
The participants were chosen according to the following eligibility criteria:
Inclusion criteria Exclusion criteria
Patient inclusion:
- Patients aging ≥18 years.
- Patients with High caries risk.
- Patients with untreated cervical caries lesion that need restorative treatment.
- Males or females
- No abnormal occlusion for selected teeth.
- Patients with good likelihood of recall availability
Tooth inclusion:
- Permanent teeth.
- Absence of mobility.
- Primary carious lesions.
- Vital with positive reaction to thermal stimulus .
Patient exclusion:
- Participants with general/systemic illness.
- Concomitant participation in another research study.
- Inability to comply with study procedures.
- Heavy bruxism habits.
- Last experience with allergic reactions against any components of the used materials.
- Patients receiving orthodontic treatment.
- Teeth supporting removable prosthesis
- Patients with cervical caries lesions that need crown restoration.
- Xerostomia.
Tooth exclusion:
- Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
- Non-vital teeth.
- Periapical Abscess or Fistula.
- Outcomes:
For each recall examination, two independent evaluators will perform the direct clinical evaluation at baseline, after 6 and 12 months using written criteria based on FDI criteria.
- Conditions
- Dental Caries Class v
- Being tested
- Glass Ionomer with Advanced Glass Hybrid Technology (Equia forte HT fil, GC, Japan)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glass Ionomer with Advanced Glass Hybrid Technology (Equia forte HT fil, GC, Japan)Drug
Advanced Glass Hybrid technology (AGH) was achieved through introduction of ultra-fine highly reactive glass and high-molecular weight polyacrylic acid powders within conventional glass using particles and fillers with close refractive indexes
| Study group | Role | What they receive |
|---|---|---|
| Glass Ionomer with Advanced Glass Hybrid Technology (Equia forte HT fil, GC, Japan) | Experimental | Glass Hybrid restorative systems in the clinical point of view are self-cure bulk fill materials laminated with a nano-filled, self-adhesive resin coat.
Nowadays, a new glass hybrid innovation called Advanced Glass Hybrid technology was achieved through introduction of ultra-fine highly reactive glass and high-molecular weight polyacrylic acid powders within conventional glass using prefractive indexes. Receives: Drug: Glass Ionomer with Advanced Glass Hybrid Technology (Equia forte HT fil, GC, Japan) |
| Resin Modified Glass Ionomer (Fugi II LC, GC, Japan). | Active comparator | Not described Receives: Drug: Glass Ionomer with Advanced Glass Hybrid Technology (Equia forte HT fil, GC, Japan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
FDI criteria
Esthetic and mechanical evaluation
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study startDec 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries Class vStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Model description
- Participants will be randomly divided into two groups with a 1:1 allocation using computer generated randomization list (www.random.org).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Magdy Zayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617703
- Sponsor's protocol ID
- 14422018462089
- Status last verified
- Nov 2022
- First submitted
- 8 Nov 2022
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: international and national publication
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Glass Ionomer With Advanced Glass Hybrid Technology Versus Resin Modified Glass Ionomer in Adult Patients With Carious Cervical Lesions After One Year: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05617703
- Acronym / sponsor ID
- 14422018462089
- Conditions
- Dental Caries Class v
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 15 Nov 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 goal of this [type of study: Randomized clinical trial] to compare the clinical performance of using glass ionomer with advanced glass hybrid technology (AGH) in cervical carious lesion, versus Resin modified glass ionomer (RMGI) using esthetic and mechanical properties according to FDI criteria over one year.
in adult patients with cervical carious lesion.
The main question it aims to answer are:
- Will the use of glass ionomer with advanced glass hybrid technology, achieved through introduction of ultra-fine highly reactive glass and high-molecular weight polyacrylic acid powders within conventional glass ,or Resin Modified Glass Ionomer have better mechanical and estheic properties over one year in adult patients with cervical carious lesions ?
Participants will be assessed for medical and dental histories first. Then an examination of the patients will be done using visual inspection by using a dental mirror and probe. Eligible patients according to inclusion and exclusion criteria will be informed about all procedures with follow up time if they accept, their signature on written informed consents will be obtained. Eligible participants will be randomly divided into two groups according to the type of restoration that will be received after class V cavity preparations for carious cervical lesions.
Patients will be given local anaesthesia (Mepecaine - L Cartridges) as required, and the teeth will be isolated. A No. #330 bur (MANI, INC, Japan) in a high-speed hand piece with air/water coolant will be used to prepare class V cavity. Sharp excavators of suitable size were used to excavate soft carious lesions in dentin. the prepared cavity will be isolated with rubber dam.
The first group (A) will be received resin modified glass ionomer restorative material and the second group (B) will be received advanced glass hybrid glass ionomer . Each restoration will be evaluated for clinical parameters after finishing and polishing at baseline and regular recalls of 6 months and one year. The restorations will be clinically examined according to FDI criteria criteria in terms of esthetic and mechanical properties . The information that will be obtained will be collected and statistically analyzed.
Detailed description
Eligibility criteria
The participants were chosen according to the following eligibility criteria:
Inclusion criteria Exclusion criteria
Patient inclusion:
- Patients aging ≥18 years.
- Patients with High caries risk.
- Patients with untreated cervical caries lesion that need restorative treatment.
- Males or females
- No abnormal occlusion for selected teeth.
- Patients with good likelihood of recall availability
Tooth inclusion:
- Permanent teeth.
- Absence of mobility.
- Primary carious lesions.
- Vital with positive reaction to thermal stimulus .
Patient exclusion:
- Participants with general/systemic illness.
- Concomitant participation in another research study.
- Inability to comply with study procedures.
- Heavy bruxism habits.
- Last experience with allergic reactions against any components of the used materials.
- Patients receiving orthodontic treatment.
- Teeth supporting removable prosthesis
- Patients with cervical caries lesions that need crown restoration.
- Xerostomia.
Tooth exclusion:
- Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
- Non-vital teeth.
- Periapical Abscess or Fistula.
- Outcomes:
For each recall examination, two independent evaluators will perform the direct clinical evaluation at baseline, after 6 and 12 months using written criteria based on FDI criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly divided into two groups with a 1:1 allocation using computer generated randomization list (www.random.org).
| Arm | Type | Receives |
|---|---|---|
| Glass Ionomer with Advanced Glass Hybrid Technology (Equia forte HT fil, GC, Japan) | Experimental | Drug: Glass Ionomer with Advanced Glass Hybrid Technology (Equia forte HT fil, GC, Japan)Glass Hybrid restorative systems in the clinical point of view are self-cure bulk fill materials laminated with a nano-filled, self-adhesive resin coat. Nowadays, a new glass hybrid innovation called Advanced Glass Hybrid technology was achieved through introduction of ultra-fine highly reactive glass and high-molecular weight polyacrylic acid powders within conventional glass using prefractive indexes. |
| Resin Modified Glass Ionomer (Fugi II LC, GC, Japan). | Active comparator | Drug: Glass Ionomer with Advanced Glass Hybrid Technology (Equia forte HT fil, GC, Japan) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient inclusion:
- Permanent teeth.
- Absence of mobility.
- Primary carious lesions.
- Vital with positive reaction to thermal stimulus .
Key exclusion criteria (6 listed)
- 1. Participants with general/systemic illness. 2. Concomitant participation in another research study. 3. Inability to comply with study procedures. 4. Heavy bruxism habits. 5. Last experience with allergic reactions against any components of the used materials.
- 6. Patients receiving orthodontic treatment. 7. Teeth supporting removable prosthesis 8. Patients with cervical caries lesions that need crown restoration. 9. Xerostomia.
- Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
- Non-vital teeth.
- Periapcal Abscess or Fistula.
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 Ionomer with Advanced Glass Hybrid Technology (Equia forte HT fil, GC, Japan)Advanced Glass Hybrid technology (AGH) was achieved through introduction of ultra-fine highly reactive glass and high-molecular weight polyacrylic acid powders within conventional glass using particles and fillers with close refractive indexes | Drug | Glass Ionomer with Advanced Glass Hybrid Technology (Equia forte HT fil, GC, Japan), Resin Modified Glass Ionomer (Fugi II LC, GC, Japan). |
Primary outcome
FDI criteria
Time frame: one year
Esthetic and mechanical evaluation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Individual participant dataSharing planned: Yes. international and national publication
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Glass Ionomer with Advanced Glass Hybrid Technology (Equia forte HT fil, GC, Japan) in people with Dental Caries Class v, run by Cairo 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 12 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: status not confirmed, as of the sponsor's last update on 15 Nov 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zayed (00201012561397, aya_magdy@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FDI criteria (time frame: one year). 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 15 Nov 2022.