Tooth DecayNCT06463574
Effect of Aging on Micro-tensile Bond Strength and Color Stability of Self-adhesive Resin Composite
A study testing self-adhesive resin restoration in people with Tooth Decay, run by Minia University at 1 site in Egypt.
Trial summary
The objective of this study is to evaluate the micro-tensile bond strength of a newly self-adhesive resinous restorative material to dentin with and without application of universal bonding system (in-vitro) and to examine it's clinical performance by evaluation of it's color stability and marginal discoloration… Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Decay
- What is being tested?
- self-adhesive resin restoration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2024to Dec 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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with class I lesion in their maxillary or mandibular molars with a maximum of approximately 2 mm final cavity depth.
- Patients with teeth shade A2 according to Vitapan classical shade guide.
- Patients with an acceptable oral hygiene level.
- Patients keen to regularly attend the follow up visits.
Who cannot join
- Patients with heavy bruxism or traumatic occlusion.
- Patients with poor oral hygiene or active periodontal disease.
- Patients with exposed or endodontically treated teeth.
- Patients participated in a clinical trial within 6 months before beginning of this trial.
- Patients who decline to be involved in the study or sign the written consent.
- Patients unable to return for the follow up visits.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Minya University.
Minya, 61519
Nourhan S Soliman, Doctor, 1066175951 ext. +20, nourhan.samir@pua.edu.eg
Nermin A Mahmoud, Doctor, 1125529583 ext. +20, nermin.alsayed@yahoo.com
About this study
Official title: Evaluation of Micro -Tensile Bond Strength to Dentin and Color Stability of a New Self Adhesive Bulk-fill Resin Composite Restorative Material After Aging
The objective of this study is to evaluate the micro-tensile bond strength of a newly self-adhesive resinous restorative material to dentin with and without application of universal bonding system (in-vitro) and to examine it's clinical performance by evaluation of it's color stability and marginal discoloration through a randomized clinical trial (in-vivo).
Read the detailed description
For color stability and marginal discoloration test, twenty class I cavities were prepared in the molar teeth of twenty different patients and then were randomly divided into two groups of ten patients each, where half of the molars was restored with Surefil one self-adhesive bulk-fill composite and the other half with Filtek One bulk-fill composite. A VITA Easyshade spectrophotometer was used to measure the baseline color of the restoration and at the margin after 24 hours and degree of color change and marginal discoloration after 3 months and 6 months of composite placement and then degree of color change (ΔE) was determined using the CIE L*a*b* system. All discolored restored molar teeth of both composite types were polished using a series of different thickness of Sof-Lex aluminum oxide discs (coarse, medium, fine), then the degree of color change of the restoration and at the margin (ΔE) was determined and was then compared to the baseline color measurements.
- Conditions
- Tooth Decay
- Being tested
- self-adhesive resin restoration
- Keywords
- Color stability, Aging, Self-adhesive
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-adhesive resin restorationOther
Also called Surefil one
Light cured, hybrid resin composite material which contains polymerization modulator that lessens its degree of polymerization shrinkage
| Study group | Role | What they receive |
|---|---|---|
| Surefil one bulk-fill composite | Experimental | Restorative material applied directly to the tooth without adhesive appliaction. Receives: Other: self-adhesive resin restoration |
| Filtek One bulk-fill composite | Active comparator | Restorative material that is applied to the tooth after adhesive application. Receives: Other: self-adhesive resin restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation of color stability and marginal discoloration of resin restorations after aging in the patient mouth.
Clinical evaluation of degree of color change of resin restorations after aging in the patient mouth.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study startJun 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Tooth DecayStudies of the same condition, open and under way.
- More trials run by Minia 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
- A total of 20 patients will be selected and divided randomly into two main groups according to the type of composite used, the first group will use Surefil one self-adhesive bulk-fill composite for restoring 10 posterior class I cavities and the second group will use 3M Filtek One high viscosity bulk-fill composite for restoring 10 posterior class I cavities.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan Samir Soliman Ibrahim, Minia University
- Investigators
- Wael Essam Jamil, Professor, Study director, Faculty of Dental Medicine for Girls, AL-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463574
- Sponsor's protocol ID
- self-adhesive resin composite
- Status last verified
- Jun 2024
- First submitted
- 23 May 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Name Faculty Country
Publications
Ellithy MS, Abdelrahman MH, Afifi RR. Comparative clinical evaluation between self-adhesive and conventional bulk-fill composites in class II cavities: A 1-year randomized controlled clinical study. J Esthet Restor Dent. 2024 Sep;36(9):1311-1325. doi: 10.1111/jerd.13242. Epub 2024 Apr 24.
PubMed 38655672Rathke A, Pfefferkorn F, McGuire MK, Heard RH, Seemann R. One-year clinical results of restorations using a novel self-adhesive resin-based bulk-fill restorative. Sci Rep. 2022 Mar 10;12(1):3934. doi: 10.1038/s41598-022-07965-z.
PubMed 35273277Cieplik F, Scholz KJ, Anthony JC, Tabenski I, Ettenberger S, Hiller KA, Buchalla W, Federlin M. One-year results of a novel self-adhesive bulk-fill restorative and a conventional bulk-fill composite in class II cavities-a randomized clinical split-mouth study. Clin Oral Investig. 2022 Jan;26(1):449-461. doi: 10.1007/s00784-021-04019-y. Epub 2021 Jun 15.
PubMed 34129074Anwar RS, Hussein YF, Riad M. Optical behavior and marginal discoloration of a single shade resin composite with a chameleon effect: a randomized controlled clinical trial. BDJ Open. 2024 Feb 20;10(1):11. doi: 10.1038/s41405-024-00184-w.
PubMed 38378771Fidan M. The effects of different repolishing procedures on the color change of bulk-fill resin composites. Eur Oral Res. 2024 Jan 5;58(1):14-21. doi: 10.26650/eor.20231234627.
PubMed 38481725Uctasli MB, Garoushi S, Uctasli M, Vallittu PK, Lassila L. A comparative assessment of color stability among various commercial resin composites. BMC Oral Health. 2023 Oct 24;23(1):789. doi: 10.1186/s12903-023-03515-9.
PubMed 37875872
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Micro -Tensile Bond Strength to Dentin and Color Stability of a New Self Adhesive Bulk-fill Resin Composite Restorative Material After Aging
- ClinicalTrials.gov ID
- NCT06463574
- Acronym / sponsor ID
- self-adhesive resin composite
- Conditions
- Tooth Decay
- Keywords
- Color stability, Aging, Self-adhesive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 18 Jun 2024 (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 objective of this study is to evaluate the micro-tensile bond strength of a newly self-adhesive resinous restorative material to dentin with and without application of universal bonding system (in-vitro) and to examine it's clinical performance by evaluation of it's color stability and marginal discoloration through a randomized clinical trial (in-vivo).
Detailed description
For color stability and marginal discoloration test, twenty class I cavities were prepared in the molar teeth of twenty different patients and then were randomly divided into two groups of ten patients each, where half of the molars was restored with Surefil one self-adhesive bulk-fill composite and the other half with Filtek One bulk-fill composite. A VITA Easyshade spectrophotometer was used to measure the baseline color of the restoration and at the margin after 24 hours and degree of color change and marginal discoloration after 3 months and 6 months of composite placement and then degree of color change (ΔE) was determined using the CIE L*a*b* system. All discolored restored molar teeth of both composite types were polished using a series of different thickness of Sof-Lex aluminum oxide discs (coarse, medium, fine), then the degree of color change of the restoration and at the margin (ΔE) was determined and was then compared to the baseline color measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- A total of 20 patients will be selected and divided randomly into two main groups according to the type of composite used, the first group will use Surefil one self-adhesive bulk-fill composite for restoring 10 posterior class I cavities and the second group will use 3M Filtek One high viscosity bulk-fill composite for restoring 10 posterior class I cavities.
| Arm | Type | Receives |
|---|---|---|
| Surefil one bulk-fill composite | Experimental | Other: self-adhesive resin restorationRestorative material applied directly to the tooth without adhesive appliaction. |
| Filtek One bulk-fill composite | Active comparator | Other: self-adhesive resin restorationRestorative material that is applied to the tooth after adhesive application. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with class I lesion in their maxillary or mandibular molars with a maximum of approximately 2 mm final cavity depth.
- Patients with teeth shade A2 according to Vitapan classical shade guide.
- Patients with an acceptable oral hygiene level.
- Patients keen to regularly attend the follow up visits.
Key exclusion criteria (6 listed)
- Patients with heavy bruxism or traumatic occlusion.
- Patients with poor oral hygiene or active periodontal disease.
- Patients with exposed or endodontically treated teeth.
- Patients participated in a clinical trial within 6 months before beginning of this trial.
- Patients who decline to be involved in the study or sign the written consent.
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 |
|---|---|---|
| self-adhesive resin restorationAlso: Surefil oneLight cured, hybrid resin composite material which contains polymerization modulator that lessens its degree of polymerization shrinkage | Other | Filtek One bulk-fill composite, Surefil one bulk-fill composite |
Primary outcome
Clinical evaluation of color stability and marginal discoloration of resin restorations after aging in the patient mouth.
Time frame: 6 months
Clinical evaluation of degree of color change of resin restorations after aging in the patient mouth.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Background: PubMed 38655672Ellithy MS, Abdelrahman MH, Afifi RR. Comparative clinical evaluation between self-adhesive and conventional bulk-fill composites in class II cavities: A 1-year randomized controlled clinical study. J Esthet Restor Dent. 2024 Sep;36(9):1311-1325. doi: 10.1111/jerd.13242. Epub 2024 Apr 24.
- Background: PubMed 35273277Rathke A, Pfefferkorn F, McGuire MK, Heard RH, Seemann R. One-year clinical results of restorations using a novel self-adhesive resin-based bulk-fill restorative. Sci Rep. 2022 Mar 10;12(1):3934. doi: 10.1038/s41598-022-07965-z.
- Background: PubMed 34129074Cieplik F, Scholz KJ, Anthony JC, Tabenski I, Ettenberger S, Hiller KA, Buchalla W, Federlin M. One-year results of a novel self-adhesive bulk-fill restorative and a conventional bulk-fill composite in class II cavities-a randomized clinical split-mouth study. Clin Oral Investig. 2022 Jan;26(1):449-461. doi: 10.1007/s00784-021-04019-y. Epub 2021 Jun 15.
- Background: PubMed 38378771Anwar RS, Hussein YF, Riad M. Optical behavior and marginal discoloration of a single shade resin composite with a chameleon effect: a randomized controlled clinical trial. BDJ Open. 2024 Feb 20;10(1):11. doi: 10.1038/s41405-024-00184-w.
- Background: PubMed 38481725Fidan M. The effects of different repolishing procedures on the color change of bulk-fill resin composites. Eur Oral Res. 2024 Jan 5;58(1):14-21. doi: 10.26650/eor.20231234627.
- Background: PubMed 37875872Uctasli MB, Garoushi S, Uctasli M, Vallittu PK, Lassila L. A comparative assessment of color stability among various commercial resin composites. BMC Oral Health. 2023 Oct 24;23(1):789. doi: 10.1186/s12903-023-03515-9.
- Individual participant dataSharing planned: Yes. Name Faculty Country
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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.
Wael Essam Jamil, Professor study director
Faculty of Dental Medicine for Girls, AL-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-adhesive resin restoration in people with Tooth Decay, run by Minia 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 4 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 18 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nourhan Samir Soliman, Assisstant Lecturer (1066175951 ext. +20, nourhan.samir@pua.edu.eh), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evaluation of color stability and marginal discoloration of resin restorations after aging in the patient mouth. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06463574, which also lists 6 linked publications.
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 18 Jun 2024.