Dental LeakageNCT04848987
Indirect Resin Composite Inlays Cemented With a Self-adhesive, Self-etch or a Conventional Resin Cement
A study testing Etching in people with Dental Leakage, run by Mansoura University at 1 site in Egypt.
Trial summary
The present study was designed to provide further evidence in this particular research prospective, and this study hence aimed to clinically evaluate the 5-years adhesion durability of indirect resin composite inlays luted with three different resin cement strategies in MOD Class II 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
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2016to 10 Sep 2020
- 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 occlusal surface only with ICDAS 2 and 3.
- Patients with cavities no more than one-third of the intercuspal distance.
- Patients must have a good oral hygiene.
- Patients with tooth gives positive response to testing with an electric pulp tester.
- Patients with normal and full occlusion.
- 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 abutments should be excluded.
- Patients with heavy bruxism habits and clenching.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Indirect Resin Composite Inlays Cemented With Three Different Luting Strategies
The present study was designed to provide further evidence in this particular research prospective, and this study hence aimed to clinically evaluate the 5-years adhesion durability of indirect resin composite inlays luted with three different resin cement strategies in MOD Class II restorations. The formulated null hypothesis was that there is no significant difference in the clinical performances of the three different resin cement strategies for luting indirect resin composite inlays in MOD Class II restorations for 5-years.
The research question was as follows: Do self-adhesive resin cements in class II restorations present better clinical performances than conventional etch-and-rinse and self-etch resin cements according to the USPHS criteria?
Read the detailed description
Objective: To clinically evaluate the 5 years adhesion durability of indirect resin composite inlays luted with three different resin cement strategies in MOD Class II restorations.
Materials and Methods: A randomized clinical trial was conducted following the protocol, 40 patients with three large cavities for each one that indicated for indirect MOD Class II restorations were enrolled in the current study. Then, 120 indirect resin composite inlay restorations (SR Nexco) were placed and luted with three different resin cement strategies; an etch-and-rinse (Variolink N), self-etch (Panavia F2.0) and self-adhesive (RelyX Unicem). Each resin cement was used for luting 20 inlay restorations. A single operator placed all restorations according to the manufacturer's instructions. Immediatelly after placement, the restorations were finished and polished. Clinical evaluation was performed at baseline and at 1, 3 and 5 years intervals after placement by two independent examiners using modified USPHS criteria. The changes in the USPHS parameters during the 5 years period were analyzed with Fredman test. The baseline scores were compared with those at the recall visits using Wilcoxon signed rank test, where the level of significance was set at p˂0.05.
- Conditions
- Dental Leakage
- Being tested
- Etching
- 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.
EtchingProcedure or surgery
Etching enamel surface using phosphoric acid
| Study group | Role | What they receive |
|---|---|---|
| Etch-and-rinse (Variolink N) resin cement | Active comparator | For etch-and-rinse resin cement, 40 inlays were cemented by Variolink N resin cement. Receives: Procedure: Etching |
| Self-etch (Panavia F2.0) resin cement | Placebo comparator | Regarding self-etch resin cement, 40 inlays were cemented by Panavia F2.0 resin cement. Receives: Procedure: Etching |
| Self-adhesive (RelyX Unicem) resin cement | No intervention | For self-adhesive resin cement, 40 inlays were cemented by RelyX Unicem resin cement. |
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: 5 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 posted19 Apr 2021
- Study start10 Oct 2016
- Primary completion10 Oct 2016
- Study completion10 Sep 2020
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
- 40 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
- NCT04848987
- Sponsor's protocol ID
- A10150421
- Status last verified
- Apr 2021
- First submitted
- 10 Apr 2021
- Last updated
- 19 Apr 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 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indirect Resin Composite Inlays Cemented With Three Different Luting Strategies
- ClinicalTrials.gov ID
- NCT04848987
- Acronym / sponsor ID
- A10150421
- Conditions
- Dental Leakage
- Keywords
- Resin Composite, Randomized Clinical Trial, Operative Dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 10 Oct 2016 (actual)
- Primary completion
- 10 Oct 2016 (actual)
- Study completion
- 10 Sep 2020 (actual)
- First posted
- 19 Apr 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.
The present study was designed to provide further evidence in this particular research prospective, and this study hence aimed to clinically evaluate the 5-years adhesion durability of indirect resin composite inlays luted with three different resin cement strategies in MOD Class II restorations. The formulated null hypothesis was that there is no significant difference in the clinical performances of the three different resin cement strategies for luting indirect resin composite inlays in MOD Class II restorations for 5-years.
The research question was as follows: Do self-adhesive resin cements in class II restorations present better clinical performances than conventional etch-and-rinse and self-etch resin cements according to the USPHS criteria?
Detailed description
Objective: To clinically evaluate the 5 years adhesion durability of indirect resin composite inlays luted with three different resin cement strategies in MOD Class II restorations.
Materials and Methods: A randomized clinical trial was conducted following the protocol, 40 patients with three large cavities for each one that indicated for indirect MOD Class II restorations were enrolled in the current study. Then, 120 indirect resin composite inlay restorations (SR Nexco) were placed and luted with three different resin cement strategies; an etch-and-rinse (Variolink N), self-etch (Panavia F2.0) and self-adhesive (RelyX Unicem). Each resin cement was used for luting 20 inlay restorations. A single operator placed all restorations according to the manufacturer's instructions. Immediatelly after placement, the restorations were finished and polished. Clinical evaluation was performed at baseline and at 1, 3 and 5 years intervals after placement by two independent examiners using modified USPHS criteria. The changes in the USPHS parameters during the 5 years period were analyzed with Fredman test. The baseline scores were compared with those at the recall visits using Wilcoxon signed rank test, where the level of significance was set at p˂0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Etch-and-rinse (Variolink N) resin cement | Active comparator | Procedure: EtchingFor etch-and-rinse resin cement, 40 inlays were cemented by Variolink N resin cement. |
| Self-etch (Panavia F2.0) resin cement | Placebo comparator | Procedure: EtchingRegarding self-etch resin cement, 40 inlays were cemented by Panavia F2.0 resin cement. |
| Self-adhesive (RelyX Unicem) resin cement | No intervention | –For self-adhesive resin cement, 40 inlays were cemented by RelyX Unicem resin cement. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients with primary caries involving occlusal surface only with ICDAS 2 and 3.
- Patients with cavities no more than one-third of the intercuspal distance.
- Patients must have a good oral hygiene.
- Patients with tooth gives positive response to testing with an electric pulp tester.
- Patients with normal and full occlusion.
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 abutments should be excluded.
- Patients with heavy bruxism habits and clenching.
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 |
|---|---|---|
| EtchingEtching enamel surface using phosphoric acid | Procedure or surgery | Etch-and-rinse (Variolink N) resin cement, Self-etch (Panavia F2.0) resin cement |
Primary outcome
Percentage % of patients with marginal staining
Time frame: 5 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 19 Apr 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 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 6 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 19 Apr 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. Some participants in this study may receive a placebo. 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: 5 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 19 Apr 2021.