Dental LeakageNCT05161559
Adhesive Performance of Glass Ionomer and Resin Based Adhesive Systems: A 3 Years Prospective Clinical Evaluation
A study testing Etching with phosphoric acid gel (3M ESPE, St. Paul, MN, USA), Self-etch adhesive (Kuraray, Tokyo, Japan) and Chemical bond adhesive (GC, Corporation, Tokyo, Japan) in people with Dental Leakage, run by Mansoura University at 1 site in Egypt.
Trial summary
This study aimed to clinically evaluate the 3-years clinical performance of glass ionomer and resin based adhesive systems in Class V restorations. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Leakage
- What is being tested?
- Etching with phosphoric acid gel (3M ESPE, St. Paul, MN, USA), Self-etch adhesive (Kuraray, Tokyo, Japan) and Chemical bond adhesive (GC, Corporation, Tokyo, Japan)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Aug 2018to 30 Oct 2021
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with primary caries involving cervical surface only with ICDAS 2 and 3.
- Patients with normal and full occlusion.
- Patients with tooth gives positive response to testing with an electric pulp tester.
- Patients must have a good oral hygiene.
- Patients with opposing teeth should be natural with no restorations.
Who cannot join
- High caries risk patients with extremely poor oral hygiene.
- Patients involved in orthodontic treatment or periodontal surgery.
- Patients with periodontally involved teeth (chronic periodontitis).
- Patients with heavy bruxism habits and clenching.
- Patients with abutments should be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adhesive Performance of Glass Ionomer Versus Resin Based Adhesive Systems
This study aimed to clinically evaluate the 3-years clinical performance of glass ionomer and resin based adhesive systems in Class V restorations.
Read the detailed description
The formulated null hypothesis was that there is no significant difference in the clinical performances between glass ionomer and resin based adhesive systems in Class V restorations for 3-years.
The research question was as follows: Do glass ionomer adhesives in class V restorations present better clinical performances than resin based adhesive systems according to the modified United States Public Health Service (modified-USPHS) criteria?
- Conditions
- Dental Leakage
- Being tested
- Etching with phosphoric acid gel (3M ESPE, St. Paul, MN, USA), Self-etch adhesive (Kuraray, Tokyo, Japan), Chemical bond adhesive (GC, Corporation, Tokyo, Japan)
- Keywords
- Resin Composite, Randomized Clinical Trial, Operative Dentistry
- Medical subject headings
- Dental Leakage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etching with phosphoric acid gel (3M ESPE, St. Paul, MN, USA)Procedure or surgery
Etching enamel surface using phosphoric acid gel (3M ESPE, St. Paul, MN, USA)
Self-etch adhesive (Kuraray, Tokyo, Japan)Procedure or surgery
No Etching enamel surface using phosphoric acid (self-etch technique) (Kuraray, Tokyo, Japan)
Chemical bond adhesive (GC, Corporation, Tokyo, Japan)Procedure or surgery
Chemical bond with hydroxyapatite crystals of Enamel (GC, Corporation, Tokyo, Japan)
| Study group | Role | What they receive |
|---|---|---|
| Fuji Bond LC (Glass ionomer based adhesive) | Experimental | Patients received in Class V cavity preparation Fuji Bond LC (Glass ionomer based adhesive) on one tooth of the mouth Receives: Procedure: Chemical bond adhesive (GC, Corporation, Tokyo, Japan) |
| Riva Bond LC (Glass ionomer based adhesive) | Experimental | Patients received in Class V cavity preparation Riva Bond LC (Glass ionomer based adhesive) on one tooth of the mouth Receives: Procedure: Chemical bond adhesive (GC, Corporation, Tokyo, Japan) |
| Single Bond Universal (self-etch adhesive) | Experimental | Patients received in Class V cavity preparation Single Bond Universal (self-etch adhesive) on one tooth of the mouth Receives: Procedure: Self-etch adhesive (Kuraray, Tokyo, Japan) |
| Clearfill S3 Bond (self-etch adhesive) | Experimental | Patients received in Class V cavity preparation Clearfill S3 Bond (self-etch adhesive) on one tooth of the mouth Receives: Procedure: Self-etch adhesive (Kuraray, Tokyo, Japan) |
| OptiBond FL (three step etch & rinse adhesive) | Experimental | Patients received in Class V cavity preparation OptiBond FL (three step etch \& rinse adhesive) on one tooth of the mouth Receives: Procedure: Etching with phosphoric acid gel (3M ESPE, St. Paul, MN, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage % of patients with marginal staining
Percentage of marginal staining in patients was clinically assessed using USPHS criteria. Restorations were given the score Alpha for the ideal clinical situation, Bravo for clinically acceptable and Charlie for clinically unacceptable and in need for replacement.
Measured: 3 years after restoration procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start30 Aug 2018
- Primary completion10 Sep 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental LeakageStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161559
- Sponsor's protocol ID
- A12151221
- Status last verified
- Dec 2021
- First submitted
- 3 Dec 2021
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study Protocol, Statistical Analysis Plan can be shared to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adhesive Performance of Glass Ionomer Versus Resin Based Adhesive Systems
- ClinicalTrials.gov ID
- NCT05161559
- Acronym / sponsor ID
- A12151221
- Conditions
- Dental Leakage
- Keywords
- Resin Composite, Randomized Clinical Trial, Operative Dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 10 Sep 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 17 Dec 2021 (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.
This study aimed to clinically evaluate the 3-years clinical performance of glass ionomer and resin based adhesive systems in Class V restorations.
Detailed description
The formulated null hypothesis was that there is no significant difference in the clinical performances between glass ionomer and resin based adhesive systems in Class V restorations for 3-years.
The research question was as follows: Do glass ionomer adhesives in class V restorations present better clinical performances than resin based adhesive systems according to the modified United States Public Health Service (modified-USPHS) criteria?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Fuji Bond LC (Glass ionomer based adhesive) | Experimental | Procedure: Chemical bond adhesive (GC, Corporation, Tokyo, Japan)Patients received in Class V cavity preparation Fuji Bond LC (Glass ionomer based adhesive) on one tooth of the mouth |
| Riva Bond LC (Glass ionomer based adhesive) | Experimental | Procedure: Chemical bond adhesive (GC, Corporation, Tokyo, Japan)Patients received in Class V cavity preparation Riva Bond LC (Glass ionomer based adhesive) on one tooth of the mouth |
| Single Bond Universal (self-etch adhesive) | Experimental | Procedure: Self-etch adhesive (Kuraray, Tokyo, Japan)Patients received in Class V cavity preparation Single Bond Universal (self-etch adhesive) on one tooth of the mouth |
| Clearfill S3 Bond (self-etch adhesive) | Experimental | Procedure: Self-etch adhesive (Kuraray, Tokyo, Japan)Patients received in Class V cavity preparation Clearfill S3 Bond (self-etch adhesive) on one tooth of the mouth |
| OptiBond FL (three step etch & rinse adhesive) | Experimental | Procedure: Etching with phosphoric acid gel (3M ESPE, St. Paul, MN, USA)Patients received in Class V cavity preparation OptiBond FL (three step etch \& rinse adhesive) on one tooth of the mouth |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with primary caries involving cervical surface only with ICDAS 2 and 3.
- Patients with normal and full occlusion.
- Patients with tooth gives positive response to testing with an electric pulp tester.
- Patients must have a good oral hygiene.
- Patients with opposing teeth should be natural with no restorations.
Key exclusion criteria (5 listed)
- High caries risk patients with extremely poor oral hygiene.
- Patients involved in orthodontic treatment or periodontal surgery.
- Patients with periodontally involved teeth (chronic periodontitis).
- Patients with heavy bruxism habits and clenching.
- Patients with abutments should be excluded.
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 |
|---|---|---|
| Etching with phosphoric acid gel (3M ESPE, St. Paul, MN, USA)Etching enamel surface using phosphoric acid gel (3M ESPE, St. Paul, MN, USA) | Procedure or surgery | OptiBond FL (three step etch & rinse adhesive) |
| Self-etch adhesive (Kuraray, Tokyo, Japan)No Etching enamel surface using phosphoric acid (self-etch technique) (Kuraray, Tokyo, Japan) | Procedure or surgery | Clearfill S3 Bond (self-etch adhesive), Single Bond Universal (self-etch adhesive) |
| Chemical bond adhesive (GC, Corporation, Tokyo, Japan)Chemical bond with hydroxyapatite crystals of Enamel (GC, Corporation, Tokyo, Japan) | Procedure or surgery | Fuji Bond LC (Glass ionomer based adhesive), Riva Bond LC (Glass ionomer based adhesive) |
Primary outcome
Percentage % of patients with marginal staining
Time frame: 3 years after restoration procedure
Percentage of marginal staining in patients was clinically assessed using USPHS criteria. Restorations were given the score Alpha for the ideal clinical situation, Bravo for clinically acceptable and Charlie for clinically unacceptable and in need for replacement.
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 17 Dec 2021.
- Individual participant dataSharing planned: Yes. study Protocol, Statistical Analysis Plan can be shared to other researchers
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 Etching with phosphoric acid gel (3M ESPE, St. Paul, MN, USA), Self-etch adhesive (Kuraray, Tokyo, Japan) and Chemical bond adhesive (GC, Corporation, Tokyo, Japan) in people with Dental Leakage, run by Mansoura 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 17 Dec 2021. 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?
Percentage % of patients with marginal staining (time frame: 3 years after restoration procedure). 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 17 Dec 2021.