Class V Dental CariesNCT05389163
Clinical Evaluation of Giomer Based Injectable Resin Composite Versus Resin Modified Glass Ionomer in Class V Carious Cavities Over 18-months.
A study testing Giomer based injectable resin composite and Resin modified glass ionomer in people with Class V Dental Caries, run by Cairo University at 1 site in Egypt.
Trial summary
Class V carious lesions will be restored using either Resin modified glass ionomer or Giomer based injectable resin composite.The restorations will be evaluated at baseline and regular recalls of 3 months, 6 months, 12 months and 18 months, using modified United States Public Health Service criteria. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Class V Dental Caries
- What is being tested?
- Giomer based injectable resin composite and Resin modified glass ionomer
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Jul 2022to 4 Jul 2024
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Participant Inclusion Criteria
- Age 18-60 years.
- Co-operative patients approving to participate in the study.
- Male or female patients.
- Patients with good general health
- Moderate or high caries risk patient
Teeth Inclusion Criteria
- Cervical Class V carious lesions.
- Pulp asymptomatic vital carious teeth.
Participant Exclusion Criteria
- Systemic disease or severe medical complications.
- Participants with a history of allergy to any component of restorations will be used in the study.
- Lack of compliance
- Evidence of severe bruxism, clenching, or temporomandibular joint disorders or bizarre habits
Teeth Exclusion Criteria
- Presence of apical or periapical pathosis.
- tooth mobility
- Non-vital teeth.
- Teeth with advanced periodontal diseases.
- Teeth which need indirect restoration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Giomer Based Injectable Resin Composite Versus Resin Modified Glass Ionomer in Class V Carious Cavities Over 18-months: Randomized Controlled Trial
Class V carious lesions will be restored using either Resin modified glass ionomer or Giomer based injectable resin composite.The restorations will be evaluated at baseline and regular recalls of 3 months, 6 months, 12 months and 18 months, using modified United States Public Health Service criteria.
Read the detailed description
In this study, Class V carious lesions will be restored using two different restorative materials either Resin modified glass ionomer or Giomer based injectable resin composite. Patients 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 they will be received.The first group (A) (Intervention): Giomer based injectable resin composite (Beautifil Flow plus X F03, SHOFU, USA): The material will be applied according to manufacturer instructions. The second group (B) (comparator): Resin modified glass ionomer (Fuji II LC, GC): The material will be applied according to manufacturer instructions.The restorations will be evaluated at baseline and regular recalls of 3 months, 6 months, 12 months and 18 months, using modified United States Public Health Service criteria (USPHS) for the following characteristics: retention, anatomical form, marginal adaptation, marginal staining, surface texture, and secondary caries . The restorations will be evaluated with the aid of a dental explorer and an intraoral mirror and visual inspection. The restorations will be scored as follows: Alfa represents the ideal clinical situation, Bravo will be clinically acceptable, and Charlie represents a clinically unacceptable situation.
- Conditions
- Class V Dental Caries
- Being tested
- Giomer based injectable resin composite, Resin modified glass ionomer
- Keywords
- Giomer, injectable resin composite, Resin modified glass ionomer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Giomer based injectable resin compositeDevice
Giomer material has been introduced as the true hybridization of glass ionomer and resin composite, containing surface pre-reacted glass ionomer (S-PRG) filler particles within a resin matrix. Giomer combines caries protection through fluoride release and recharge of glass ionomers and the esthetics, physical and handling properties of resin composite
Resin modified glass ionomerDevice
Resin modified glass ionomer (RMGI) have been developed to combine the advantages of both resin composite and glass ionomer; the good mechanical properties, esthetic of resin composite added to anticariogenic activity and chemical bonding to tooth structure of glass Ionomer.
| Study group | Role | What they receive |
|---|---|---|
| Giomer based injectable resin composite | Experimental | Beautifil Flow plus X F03, SHOFU, USA Receives: Device: Giomer based injectable resin composite |
| Resin modified glass ionomer | Active comparator | Fuji II LC, GC Receives: Device: Resin modified glass ionomer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance (Marginal adaptation)
Method of measurement is Modified United State Public Health Service Criteria (Modified USPHS) using (Alpha, Bravo, charlie) as unit of measurement by Scoring %.
Alpha is the best outcome and charlie is the worse outcome .
Measured: 18 months
Secondary outcomes (1)
Clinical performance (Anatomical form, marginal discoloration, Secondary caries, surface texture , Postoperative sensitivity, Retention,)
Method of measurement is Modified United State Public Health Service Criteria (Modified USPHS) using (Alpha, Bravo, charlie) as unit of measurement by Scoring %.
Alpha is the best outcome and charlie worse outcome .
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start17 Jul 2022
- Primary completion5 Apr 2024
- Study completion4 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class V Dental CariesStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Adel Yahia Hendam, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389163
- Sponsor's protocol ID
- Giomer vs RMGI in class V
- Status last verified
- Jul 2024
- First submitted
- 12 May 2022
- Last updated
- 10 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Giomer Based Injectable Resin Composite Versus Resin Modified Glass Ionomer in Class V Carious Cavities Over 18-months: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05389163
- Acronym / sponsor ID
- Giomer vs RMGI in class V
- Conditions
- Class V Dental Caries
- Keywords
- Giomer, injectable resin composite, Resin modified glass ionomer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 17 Jul 2022 (actual)
- Primary completion
- 5 Apr 2024 (actual)
- Study completion
- 4 Jul 2024 (actual)
- First posted
- 25 May 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.
Class V carious lesions will be restored using either Resin modified glass ionomer or Giomer based injectable resin composite.The restorations will be evaluated at baseline and regular recalls of 3 months, 6 months, 12 months and 18 months, using modified United States Public Health Service criteria.
Detailed description
In this study, Class V carious lesions will be restored using two different restorative materials either Resin modified glass ionomer or Giomer based injectable resin composite. Patients 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 they will be received.The first group (A) (Intervention): Giomer based injectable resin composite (Beautifil Flow plus X F03, SHOFU, USA): The material will be applied according to manufacturer instructions. The second group (B) (comparator): Resin modified glass ionomer (Fuji II LC, GC): The material will be applied according to manufacturer instructions.The restorations will be evaluated at baseline and regular recalls of 3 months, 6 months, 12 months and 18 months, using modified United States Public Health Service criteria (USPHS) for the following characteristics: retention, anatomical form, marginal adaptation, marginal staining, surface texture, and secondary caries . The restorations will be evaluated with the aid of a dental explorer and an intraoral mirror and visual inspection. The restorations will be scored as follows: Alfa represents the ideal clinical situation, Bravo will be clinically acceptable, and Charlie represents a clinically unacceptable situation.
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 based injectable resin composite | Experimental | Device: Giomer based injectable resin compositeBeautifil Flow plus X F03, SHOFU, USA |
| Resin modified glass ionomer | Active comparator | Device: Resin modified glass ionomerFuji II LC, GC |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Giomer based injectable resin compositeGiomer material has been introduced as the true hybridization of glass ionomer and resin composite, containing surface pre-reacted glass ionomer (S-PRG) filler particles within a resin matrix. Giomer combines caries protection through fluoride release and recharge of glass ionomers and the esthetics, physical and handling properties of resin composite | Device | Giomer based injectable resin composite |
| Resin modified glass ionomerResin modified glass ionomer (RMGI) have been developed to combine the advantages of both resin composite and glass ionomer; the good mechanical properties, esthetic of resin composite added to anticariogenic activity and chemical bonding to tooth structure of glass Ionomer. | Device | Resin modified glass ionomer |
Primary outcome
Clinical performance (Marginal adaptation)
Time frame: 18 months
Method of measurement is Modified United State Public Health Service Criteria (Modified USPHS) using (Alpha, Bravo, charlie) as unit of measurement by Scoring %. Alpha is the best outcome and charlie is the worse outcome .
1 secondary outcome
Clinical performance (Anatomical form, marginal discoloration, Secondary caries, surface texture , Postoperative sensitivity, Retention,)
Time frame: 18 months
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 10 Jul 2024.
- Individual participant dataSharing planned: Yes
Related trials for Class V Dental Caries
Active, not recruiting
Two Year Clinical Performance of Ion-releasing and Non Ion-releasing Composite Restorative Systems in Restoring Cervical Carious Lesions.
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Zirconia-Reinforced Glass Ionomer Versus Injectable Giomer in Class V Restorations
Class V Dental Caries, Type 2 Diabetes Mellitus, Giomer Technology; Injectable Resin Composite; Zirconia-Modified Glass Ionomer
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Self-Cure vs. Highly Filled Flowable Composite in Carious Cervical Lesions: 18-Month RCT
Carious Cervical Lesions
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Clinical Performance of Giomer-Based Composite Restorations in Class V Carious Lesions in Diabetic and Non-Diabetic Patients
Diabetes Mellitus
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Comparative Evaluation of Class V Restorations
Secondary Caries, Dental Restoration Failure of Marginal Integrity
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Giomer based injectable resin composite and Resin modified glass ionomer in people with Class V Dental Caries, run by Cairo 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?
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 10 Jul 2024. 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?
Clinical performance (Marginal adaptation) (time frame: 18 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 10 Jul 2024.