Matrix Metalloproteinase InhibitorsNCT02744703
Effect of Caffeic Acid Phenethyl Ester as a Matrix Metalloproteinase Inhibitor: Randomized Controlled Clinical Trial
A study testing total-etch adhesive, CAPE-T and self-etch adhesive in people with Matrix Metalloproteinase Inhibitors and Composite Resins, run by Ege University.
Trial summary
Matrix metalloproteinases (MMPs); activated by the application of adhesive systems on dentin cause degradation of the collagen proteins and loss of bond strength in adhesive restorations. Caffeic acid phenethyl ester (CAPE) showed inhibitory activities on dentinal MMPs. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Matrix Metalloproteinase Inhibitors, Composite Resins
- What is being tested?
- total-etch adhesive, CAPE-T and self-etch adhesive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to May 2015
- 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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Occlusally functioning teeth without any anomalies
- Good oral hygiene
- No systemical disorders
- No periodontal diseases
- No allergic reactions to the dental materials
Who cannot join
- Patients not eligible for premolar teeth extraction for orthodontic treatment
- Poor oral hygiene
- Non-functioning premolar teeth to be included
- Patients having systemical disorders, periodontal diseases or allergic reactions to dental materials
About this study
Official title: Professor, Ege University Faculty of Dentistry
Matrix metalloproteinases (MMPs); activated by the application of adhesive systems on dentin cause degradation of the collagen proteins and loss of bond strength in adhesive restorations. Caffeic acid phenethyl ester (CAPE) showed inhibitory activities on dentinal MMPs. It is hypothesised that dentin pretreatment with CAPE, as an MMP inhibitor, would be beneficial for the bonding of resin material and tooth substrate over the course of time. This study evaluated the effect of 5 % CAPE pretreatment on the microtensile bond strength of a nanohybrid resin restoration applied with total-etch or self-etch adhesive systems on 10 patients (12-18 yrs). Two standard cavities (3 x 3 x 4 mm) prepared on the occlusal surfaces of one of the two premolar teeth in each patient were randomly assigned into four treatment groups (n=10); 5% CAPE pretreatment and total-etch adhesive (TC), Total-etch adhesive (control) (T), 5% CAPE pretreatment and self-etch adhesive (SC), Self-etch adhesive (control) (S) followed by restoration and 3 months of intra-oral functioning. After teeth extraction, the specimens were stored in distilled water+thymol solution at 4°C to inhibit microbial growth and used in one week period. Dentin-composite sticks were obtained from each restoration for µTBS tests and scanning electron microscopy (SEM) evaluation. Failure mode analysis was performed microscopically. Data were analysed statistically using Repeated Measure ANOVA (p < 0.05). Dentin pretreatment with CAPE solution (5%) for 60 seconds significantly increased the composite resin restorations' bond strengths to dentin applied with either total-etch or self-etch adhesive system. Thus it can be used as an MMP inhibitor prior to the the resin restorations. However further long term clinical studies are needed to support the use of CAPE pretreatment along with self-etch and total-etch adhesive systems.
Read the detailed description
The aim of the present study was to evaluate the effect of caffeic acid phenethyl ester (CAPE) pretreatment used as matrix metalloproteinase (MMP) inhibitor on microtensile bond strength (µTBS) of nanohybrid resin restorations applied with total-etch or self-etch adhesive systems. A total of 10 patients aged between 12 and 18 years old (4 males, 6 females, mean age:15) received 40 composite restorations. The patients who had contralateral pairs of caries-free premolars which were planned to be extracted for orthodontic treatment were enrolled in the study. This study was performed with a protocol approved by the Ethical Committee for Clinical Studies, Faculty of Medicine, University of Ege, Izmir, Turkey (04.10.2012; no:12-8/6). The treatments were performed after the informed consents were received both from the parents and the patients. Included teeth were in function and no anomalies were found neither in teeth nor in occlusion. Two standard cavities (3 x 3 x 4 mm) with continuous enamel cavosurface margins were prepared on the occlusal surfaces of each premolar tooth.Totally four cavities in each patient were randomly assigned into four treatment groups (n=10); Group TC: CAPE and total-etch adhesive (Syntac; Ivoclar Vivadent AG), Group T: Total-etch adhesive (control), Group SC: CAPE and self-etch adhesive (AdheSE; Ivoclar Vivadent AG), Group S: Self-etch adhesive (control). All cavities were restored incrementally with a nano-filled hybrid composite resin (Tetric-N-Ceram, Ivoclar Vivadent AG) in which polymerization in each layer was performed for 40 seconds with a light-curing unit (BluePhase Ivoclar Vivadent AG) exceeding an energy output of 500mw/sec.
- Being tested
- total-etch adhesive, CAPE-T, self-etch adhesive, CAPE-S
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total-etch adhesiveDrug
Also called adhesive
comparator use of total-etch adhesive
CAPE-TDrug
Also called CAPE solution
experimental group
self-etch adhesiveDrug
Also called adhesive
comparator use of total-etch adhesive
CAPE-SDrug
Also called CAPE solution
experimental group
| Study group | Role | What they receive |
|---|---|---|
| self-etch adhesive | Active comparator | application of self-etch adhesive on cavities. Receives: Drug: self-etch adhesive |
| CAPE-S | Experimental | CAPE before self-etch adhesive Receives: Drug: CAPE-S |
| total-etch adhesive | Active comparator | total-etch adhesive on cavities. Receives: Drug: total-etch adhesive |
| CAPE-T | Experimental | CAPE before total-etch adhesive application Receives: Drug: CAPE-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of structural integrity of hybrid layer in forty restorations on 10 patients using scanning electron microscopy after application of different adhesive strategies and a matrix metalloproteinase inhibitor.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startApr 2013
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Matrix Metalloproteinase InhibitorsStudies of the same condition, open and under way.
- More trials run by Ege 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Mine Dundar Comlekoglu, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744703
- Sponsor's protocol ID
- 04.10.2012; no:12-8/6
- Status last verified
- Apr 2016
- First submitted
- 3 Apr 2016
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Professor, Ege University Faculty of Dentistry
- ClinicalTrials.gov ID
- NCT02744703
- Acronym / sponsor ID
- 04.10.2012; no:12-8/6
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 20 Apr 2016 (estimated)
- 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.
Matrix metalloproteinases (MMPs); activated by the application of adhesive systems on dentin cause degradation of the collagen proteins and loss of bond strength in adhesive restorations. Caffeic acid phenethyl ester (CAPE) showed inhibitory activities on dentinal MMPs. It is hypothesised that dentin pretreatment with CAPE, as an MMP inhibitor, would be beneficial for the bonding of resin material and tooth substrate over the course of time. This study evaluated the effect of 5 % CAPE pretreatment on the microtensile bond strength of a nanohybrid resin restoration applied with total-etch or self-etch adhesive systems on 10 patients (12-18 yrs). Two standard cavities (3 x 3 x 4 mm) prepared on the occlusal surfaces of one of the two premolar teeth in each patient were randomly assigned into four treatment groups (n=10); 5% CAPE pretreatment and total-etch adhesive (TC), Total-etch adhesive (control) (T), 5% CAPE pretreatment and self-etch adhesive (SC), Self-etch adhesive (control) (S) followed by restoration and 3 months of intra-oral functioning. After teeth extraction, the specimens were stored in distilled water+thymol solution at 4°C to inhibit microbial growth and used in one week period. Dentin-composite sticks were obtained from each restoration for µTBS tests and scanning electron microscopy (SEM) evaluation. Failure mode analysis was performed microscopically. Data were analysed statistically using Repeated Measure ANOVA (p < 0.05). Dentin pretreatment with CAPE solution (5%) for 60 seconds significantly increased the composite resin restorations' bond strengths to dentin applied with either total-etch or self-etch adhesive system. Thus it can be used as an MMP inhibitor prior to the the resin restorations. However further long term clinical studies are needed to support the use of CAPE pretreatment along with self-etch and total-etch adhesive systems.
Detailed description
The aim of the present study was to evaluate the effect of caffeic acid phenethyl ester (CAPE) pretreatment used as matrix metalloproteinase (MMP) inhibitor on microtensile bond strength (µTBS) of nanohybrid resin restorations applied with total-etch or self-etch adhesive systems. A total of 10 patients aged between 12 and 18 years old (4 males, 6 females, mean age:15) received 40 composite restorations. The patients who had contralateral pairs of caries-free premolars which were planned to be extracted for orthodontic treatment were enrolled in the study. This study was performed with a protocol approved by the Ethical Committee for Clinical Studies, Faculty of Medicine, University of Ege, Izmir, Turkey (04.10.2012; no:12-8/6). The treatments were performed after the informed consents were received both from the parents and the patients. Included teeth were in function and no anomalies were found neither in teeth nor in occlusion. Two standard cavities (3 x 3 x 4 mm) with continuous enamel cavosurface margins were prepared on the occlusal surfaces of each premolar tooth.Totally four cavities in each patient were randomly assigned into four treatment groups (n=10); Group TC: CAPE and total-etch adhesive (Syntac; Ivoclar Vivadent AG), Group T: Total-etch adhesive (control), Group SC: CAPE and self-etch adhesive (AdheSE; Ivoclar Vivadent AG), Group S: Self-etch adhesive (control). All cavities were restored incrementally with a nano-filled hybrid composite resin (Tetric-N-Ceram, Ivoclar Vivadent AG) in which polymerization in each layer was performed for 40 seconds with a light-curing unit (BluePhase Ivoclar Vivadent AG) exceeding an energy output of 500mw/sec.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| self-etch adhesive | Active comparator | Drug: self-etch adhesiveapplication of self-etch adhesive on cavities. |
| CAPE-S | Experimental | Drug: CAPE-SCAPE before self-etch adhesive |
| total-etch adhesive | Active comparator | Drug: total-etch adhesivetotal-etch adhesive on cavities. |
| CAPE-T | Experimental | Drug: CAPE-TCAPE before total-etch adhesive application |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Occlusally functioning teeth without any anomalies
- Good oral hygiene
- No systemical disorders
- No periodontal diseases
- No allergic reactions to the dental materials
Key exclusion criteria (4 listed)
- Patients not eligible for premolar teeth extraction for orthodontic treatment
- Poor oral hygiene
- Non-functioning premolar teeth to be included
- Patients having systemical disorders, periodontal diseases or allergic reactions to dental materials
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 |
|---|---|---|
| total-etch adhesiveAlso: adhesivecomparator use of total-etch adhesive | Drug | total-etch adhesive |
| CAPE-TAlso: CAPE solutionexperimental group | Drug | CAPE-T |
| self-etch adhesiveAlso: adhesivecomparator use of total-etch adhesive | Drug | self-etch adhesive |
| CAPE-SAlso: CAPE solutionexperimental group | Drug | CAPE-S |
Primary outcome
Determination of structural integrity of hybrid layer in forty restorations on 10 patients using scanning electron microscopy after application of different adhesive strategies and a matrix metalloproteinase inhibitor.
Time frame: 2 years
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 20 Apr 2016.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing total-etch adhesive, CAPE-T and self-etch adhesive in people with Matrix Metalloproteinase Inhibitors and Composite Resins, run by Ege 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 5 inclusion and 4 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 20 Apr 2016. 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?
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?
Determination of structural integrity of hybrid layer in forty restorations on 10 patients using scanning electron microscopy after application of different adhesive strategies and a matrix metalloproteinase inhibitor. (time frame: 2 years). 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 20 Apr 2016.