Class I Composite RestorationsNCT05801458
Evaluation of Resin Composite Posterior Restorations Using Modeling Resin Insertion Technique in Class I Lesions
A study testing Modeling Resin Insertion Technique and Conventional resin composite Incremental Placement Technique in people with Class I Composite Restorations, run by Cairo University.
Trial summary
Evaluation of Resin Composite Posterior Restorations Using Modeling Resin Insertion Technique versus Conventional Composite Placement Technique in Class I Lesions: Randomized Clinical Trial Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Class I Composite Restorations
- What is being tested?
- Modeling Resin Insertion Technique and Conventional resin composite Incremental Placement Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 1 Nov 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
- Participants:
- Adult Patients (25-45).
- Good oral hygiene (plaque index score 0 or 1).
- Absence of damaging habits (e.g. bruxism, nail biting, tooth clenching and mouth breathing).
- Teeth:
- Vital teeth with a normal appearance and morphology.
- Primary carious lesions in molar teeth.
Who cannot join
- Participants:
- Patients with bad oral hygiene.
- Patients with known allergic or adverse reaction to the tested materials.
- Any uncontrolled systemic disease, pregnant or lactating women and any patient incapable to be present at recall follow up visits.
- Teeth:
- Non-vital, fractured, or cracked teeth.
Show all 9Show fewer
- Teeth with secondary caries or in need of replacement of existing restorations.
- Defective restorations adjacent to or opposite the tooth restored in the study.
- Rampant caries, atypical extrinsic staining of teeth.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Resin Composite Posterior Restorations Using Modeling Resin Insertion Technique Versus Conventional Composite Placement Technique in Class I Lesions: Randomized Clinical Trial
Evaluation of Resin Composite Posterior Restorations Using Modeling Resin Insertion Technique versus Conventional Composite Placement Technique in Class I Lesions: Randomized Clinical Trial
Read the detailed description
Statement of the problem In a restorative procedure, an important objective is to obtain restorations with smooth surfaces. Surface roughness has a major influence on plaque accumulation, secondary caries, and gingival irritation. Further, it may directly influence wear behavior and the marginal integrity of composite restorations. A roughened surface of a resin composite restoration is also likely to be stained by exogenous sources, such as coffee, tea, or red wine, leading to the discoloration of the material.
One of the main drawbacks of sculpting composite restorations is that some materials are sticky, reducing the ease of handling and insertion of the material into the tooth cavity. Some materials readily adhere to the composite instruments; thus, limiting reestablishment of the shape and anatomical contour of the tooth. As a result, the application of lubricants on the composite instrument such as modeling liquids/resins between the layers of composite have been proposed.
Rationale Modeling resins can be directly applied between the layers using a brush or can be used as a lubricant on manual instruments. In both the aforementioned techniques, the ease of instrumentation during the placement of esthetic restorations is superior, compared to the traditional restorative techniques. Moreover, any pores or gaps on the surface of the composite placed by means of the layering technique can be easily resolved. Hence, the modeling resin facilitates the reduction of defects in the body of the restoration and aids in improving the mechanical properties.
Although these methods are widely used, a potential shortcoming is that these techniques may adversely affect the physical and surface properties of the resin composite. However, it is unknown whether different compositions of adhesives or modeling agents may affect the surface microhardness, surface roughness, and color stability of composites over time.
- Conditions
- Class I Composite Restorations
- Being tested
- Modeling Resin Insertion Technique, Conventional resin composite Incremental Placement Technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modeling Resin Insertion TechniqueProcedure or surgery
One drop of modeling resin will be dispensed into a clean mixing well. Following the placement of the resin composite into the prepared site, a composite instrument (round-ended plugger with a diameter of 2 mm) will be dipped into the modeling resin. With modeling resin on the instrument, the resin composite is sculpted and manipulated to the desired shape. This will be repeated with each increment. Each increment will be polymerized for 20 sec with a LED light-curing unit.
Conventional resin composite Incremental Placement TechniqueProcedure or surgery
A three-step etch-and-rinse adhesive system will be used according to the manufacturer's instructions. 37.5% phosphoric acid (Kerr Co, Orange, CA, USA) will be applied to the enamel and dentin for a period of 30 s and 15 s, respectively. Subsequently the cavities will then be rinsed with an air/water spray for 15 s. A layer of primer will be applied to the dentin for 30 sec, afterward gentle air-drying for 5 sec. Then, the bond (AdheSE adhesive) will be applied on the enamel and dentin and light cured with a LED curing unit for about 30 sec. Tetric N-Ceram will then be applied using an incremental filling technique, each increment will not exceed 2mm in thickness. Each increment will be polymerized for 20 sec with a LED light-curing unit.
| Study group | Role | What they receive |
|---|---|---|
| Modeling Resin Insertion Technique | Experimental | Resin Composite (Tetric® N-Ceram Nano-hybrid incremental composite) / Wetting Agent (Modeling Resin, Bisco) Receives: Procedure: Modeling Resin Insertion Technique |
| Conventional Resin Composite Incremental Placement Technique | Placebo comparator | Conventional resin composite incremental placement technique (Tetric® N-Ceram Nano-hybrid incremental composite) Receives: Procedure: Conventional resin composite Incremental Placement Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Marginal Discoloration at 3,6,12 & 18 months
Modified US Public Health Service criteria. Possible scores range from alpha (Excellent) to delta (Immediate replacement necessary).
Measured: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Secondary outcomes (7)
Change from baseline in Marginal Integrity at 3,6,12 & 18 months
Modified US Public Health Service criteria. Possible scores range from alpha (Excellent) to delta (Immediate replacement necessary).
Measured: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Change from baseline in Color Match at 3,6,12 & 18 months
Modified US Public Health Service criteria. Possible scores range from alpha (Excellent) to charlie (outside the acceptable range).
Measured: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Change from baseline in Surface Roughness at 3,6,12 & 18 months
Modified US Public Health Service criteria. Possible scores range from alpha (Excellent) to delta (Immediate replacement necessary).
Measured: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Change from baseline in Anatomic form (wear) at 3,6,12 & 18 months
Modified US Public Health Service criteria. Possible scores range from alpha (Excellent) to delta (Immediate replacement necessary).
Measured: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Change from baseline in Retention of Restoration at 3,6,12 & 18 months
Modified US Public Health Service criteria. Possible scores range from alpha (Excellent) to charlie (complete loss of restoration).
Measured: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Change from baseline in Secondary Caries at 3,6,12 & 18 months
Modified US Public Health Service criteria. Possible scores range from alpha (Excellent) to bravo (Caries contiguous with the restoration margin).
Measured: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Change from baseline in Postoperative Sensitivity at 3,6,12 & 18 months
Modified US Public Health Service criteria. Possible scores range from alpha (Excellent) to delta (Immediate replacement necessary).
Measured: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start1 May 2023 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Class I Composite RestorationsStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Ahmed Mahmoud Mohamed, Cairo University
- Investigators
- Mostafa Abdelhamid, Professor-Cairo University, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801458
- Sponsor's protocol ID
- Modeling Resin
- Status last verified
- Mar 2023
- First submitted
- 13 Mar 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Barcellos DC, Pucci CR, Torres CR, Goto EH, Inocencio AC. Effects of resinous monomers used in restorative dental modeling on the cohesive strength of composite resin. J Adhes Dent. 2008 Oct;10(5):351-4.
PubMed 19058680Bayraktar ET, Atali PY, Korkut B, Kesimli EG, Tarcin B, Turkmen C. Effect of Modeling Resins on Microhardness of Resin Composites. Eur J Dent. 2021 Jul;15(3):481-487. doi: 10.1055/s-0041-1725577. Epub 2021 May 26.
PubMed 34041724Burke FJ, Crisp RJ, James A, Mackenzie L, Pal A, Sands P, Thompson O, Palin WM. Two year clinical evaluation of a low-shrink resin composite material in UK general dental practices. Dent Mater. 2011 Jul;27(7):622-30. doi: 10.1016/j.dental.2011.02.012. Epub 2011 Apr 22.
PubMed 21514654Dionysopoulos D, Papadopoulos C, Koliniotou-Koumpia E. The evaluation of various restoration techniques on internal adaptation of composites in class v cavities. Int J Biomater. 2014;2014:148057. doi: 10.1155/2014/148057. Epub 2014 Oct 2.
PubMed 25349611Furuse AY, Gordon K, Rodrigues FP, Silikas N, Watts DC. Colour-stability and gloss-retention of silorane and dimethacrylate composites with accelerated aging. J Dent. 2008 Nov;36(11):945-52. doi: 10.1016/j.jdent.2008.08.001. Epub 2008 Sep 7.
PubMed 18778884He Z, Shimada Y, Tagami J. The effects of cavity size and incremental technique on micro-tensile bond strength of resin composite in Class I cavities. Dent Mater. 2007 May;23(5):533-8. doi: 10.1016/j.dental.2006.03.012. Epub 2006 May 24.
PubMed 16725190Ilie N, Kessler A, Durner J. Influence of various irradiation processes on the mechanical properties and polymerisation kinetics of bulk-fill resin based composites. J Dent. 2013 Aug;41(8):695-702. doi: 10.1016/j.jdent.2013.05.008. Epub 2013 May 21.
PubMed 23707645Jefferies SR. Abrasive finishing and polishing in restorative dentistry: a state-of-the-art review. Dent Clin North Am. 2007 Apr;51(2):379-97, ix. doi: 10.1016/j.cden.2006.12.002.
PubMed 17532918Kohler B, Rasmusson CG, Odman P. A five-year clinical evaluation of Class II composite resin restorations. J Dent. 2000 Feb;28(2):111-6. doi: 10.1016/s0300-5712(99)00059-7.
PubMed 10666968Munchow EA, Sedrez-Porto JA, Piva E, Pereira-Cenci T, Cenci MS. Use of dental adhesives as modeler liquid of resin composites. Dent Mater. 2016 Apr;32(4):570-7. doi: 10.1016/j.dental.2016.01.002. Epub 2016 Feb 3.
PubMed 26850844Nahsan FP, Mondelli RF, Franco EB, Naufel FS, Ueda JK, Schmitt VL, Baseggio W. Clinical strategies for esthetic excellence in anterior tooth restorations: understanding color and composite resin selection. J Appl Oral Sci. 2012 Mar-Apr;20(2):151-6. doi: 10.1590/s1678-77572012000200005.
PubMed 22666829Rees JS, Jagger DC, Williams DR, Brown G, Duguid W. A reappraisal of the incremental packing technique for light cured composite resins. J Oral Rehabil. 2004 Jan;31(1):81-4. doi: 10.1046/j.0305-182x.2003.01073.x.
PubMed 15125602Rosa WL, Piva E, Silva AF. Bond strength of universal adhesives: A systematic review and meta-analysis. J Dent. 2015 Jul;43(7):765-76. doi: 10.1016/j.jdent.2015.04.003. Epub 2015 Apr 14.
PubMed 25882585Sedrez-Porto JA, Munchow EA, Cenci MS, Pereira-Cenci T. Translucency and color stability of resin composite and dental adhesives as modeling liquids - A one-year evaluation. Braz Oral Res. 2017 Jul 3;31:e54. doi: 10.1590/1807-3107BOR-2017.vol31.0054.
PubMed 28678973Sirin Karaarslan E, Bulbul M, Yildiz E, Secilmis A, Sari F, Usumez A. Effects of different polishing methods on color stability of resin composites after accelerated aging. Dent Mater J. 2013;32(1):58-67. doi: 10.4012/dmj.2012-045.
PubMed 23370871
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Resin Composite Posterior Restorations Using Modeling Resin Insertion Technique Versus Conventional Composite Placement Technique in Class I Lesions: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05801458
- Acronym / sponsor ID
- Modeling Resin
- Conditions
- Class I Composite Restorations
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 6 Apr 2023 (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.
Evaluation of Resin Composite Posterior Restorations Using Modeling Resin Insertion Technique versus Conventional Composite Placement Technique in Class I Lesions: Randomized Clinical Trial
Detailed description
Statement of the problem In a restorative procedure, an important objective is to obtain restorations with smooth surfaces. Surface roughness has a major influence on plaque accumulation, secondary caries, and gingival irritation. Further, it may directly influence wear behavior and the marginal integrity of composite restorations. A roughened surface of a resin composite restoration is also likely to be stained by exogenous sources, such as coffee, tea, or red wine, leading to the discoloration of the material.
One of the main drawbacks of sculpting composite restorations is that some materials are sticky, reducing the ease of handling and insertion of the material into the tooth cavity. Some materials readily adhere to the composite instruments; thus, limiting reestablishment of the shape and anatomical contour of the tooth. As a result, the application of lubricants on the composite instrument such as modeling liquids/resins between the layers of composite have been proposed.
Rationale Modeling resins can be directly applied between the layers using a brush or can be used as a lubricant on manual instruments. In both the aforementioned techniques, the ease of instrumentation during the placement of esthetic restorations is superior, compared to the traditional restorative techniques. Moreover, any pores or gaps on the surface of the composite placed by means of the layering technique can be easily resolved. Hence, the modeling resin facilitates the reduction of defects in the body of the restoration and aids in improving the mechanical properties.
Although these methods are widely used, a potential shortcoming is that these techniques may adversely affect the physical and surface properties of the resin composite. However, it is unknown whether different compositions of adhesives or modeling agents may affect the surface microhardness, surface roughness, and color stability of composites over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modeling Resin Insertion Technique | Experimental | Procedure: Modeling Resin Insertion TechniqueResin Composite (Tetric® N-Ceram Nano-hybrid incremental composite) / Wetting Agent (Modeling Resin, Bisco) |
| Conventional Resin Composite Incremental Placement Technique | Placebo comparator | Procedure: Conventional resin composite Incremental Placement TechniqueConventional resin composite incremental placement technique (Tetric® N-Ceram Nano-hybrid incremental composite) |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adult Patients (25-45).
- Good oral hygiene (plaque index score 0 or 1).
- Absence of damaging habits (e.g. bruxism, nail biting, tooth clenching and mouth breathing).
- Vital teeth with a normal appearance and morphology.
- Primary carious lesions in molar teeth.
Key exclusion criteria (9 listed)
- Patients with bad oral hygiene.
- Patients with known allergic or adverse reaction to the tested materials.
- Any uncontrolled systemic disease, pregnant or lactating women and any patient incapable to be present at recall follow up visits.
- Non-vital, fractured, or cracked teeth.
- Teeth with secondary caries or in need of replacement of existing restorations.
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 |
|---|---|---|
| Modeling Resin Insertion TechniqueOne drop of modeling resin will be dispensed into a clean mixing well. Following the placement of the resin composite into the prepared site, a composite instrument (round-ended plugger with a diameter of 2 mm) will be dipped into the modeling resin. With modeling resin on the instrument, the resin composite is sculpted and manipulated to the desired shape. This will be repeated with each increment. Each increment will be polymerized for 20 sec with a LED light-curing unit. | Procedure or surgery | Modeling Resin Insertion Technique |
| Conventional resin composite Incremental Placement TechniqueA three-step etch-and-rinse adhesive system will be used according to the manufacturer's instructions. 37.5% phosphoric acid (Kerr Co, Orange, CA, USA) will be applied to the enamel and dentin for a period of 30 s and 15 s, respectively. Subsequently the cavities will then be rinsed with an air/water spray for 15 s. A layer of primer will be applied to the dentin for 30 sec, afterward gentle air-drying for 5 sec. Then, the bond (AdheSE adhesive) will be applied on the enamel and dentin and light cured with a LED curing unit for about 30 sec. Tetric N-Ceram will then be applied using an incremental filling technique, each increment will not exceed 2mm in thickness. Each increment will be polymerized for 20 sec with a LED light-curing unit. | Procedure or surgery | Conventional Resin Composite Incremental Placement Technique |
Primary outcome
Change from baseline in Marginal Discoloration at 3,6,12 & 18 months
Time frame: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Modified US Public Health Service criteria. Possible scores range from alpha (Excellent) to delta (Immediate replacement necessary).
7 secondary outcomes
Change from baseline in Marginal Integrity at 3,6,12 & 18 months
Time frame: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Change from baseline in Color Match at 3,6,12 & 18 months
Time frame: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Change from baseline in Surface Roughness at 3,6,12 & 18 months
Time frame: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Change from baseline in Anatomic form (wear) at 3,6,12 & 18 months
Time frame: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Change from baseline in Retention of Restoration at 3,6,12 & 18 months
Time frame: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Change from baseline in Secondary Caries at 3,6,12 & 18 months
Time frame: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Change from baseline in Postoperative Sensitivity at 3,6,12 & 18 months
Time frame: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Background: PubMed 19058680Barcellos DC, Pucci CR, Torres CR, Goto EH, Inocencio AC. Effects of resinous monomers used in restorative dental modeling on the cohesive strength of composite resin. J Adhes Dent. 2008 Oct;10(5):351-4.
- Background: PubMed 34041724Bayraktar ET, Atali PY, Korkut B, Kesimli EG, Tarcin B, Turkmen C. Effect of Modeling Resins on Microhardness of Resin Composites. Eur J Dent. 2021 Jul;15(3):481-487. doi: 10.1055/s-0041-1725577. Epub 2021 May 26.
- Background: PubMed 21514654Burke FJ, Crisp RJ, James A, Mackenzie L, Pal A, Sands P, Thompson O, Palin WM. Two year clinical evaluation of a low-shrink resin composite material in UK general dental practices. Dent Mater. 2011 Jul;27(7):622-30. doi: 10.1016/j.dental.2011.02.012. Epub 2011 Apr 22.
- Background: PubMed 25349611Dionysopoulos D, Papadopoulos C, Koliniotou-Koumpia E. The evaluation of various restoration techniques on internal adaptation of composites in class v cavities. Int J Biomater. 2014;2014:148057. doi: 10.1155/2014/148057. Epub 2014 Oct 2.
- Background: PubMed 18778884Furuse AY, Gordon K, Rodrigues FP, Silikas N, Watts DC. Colour-stability and gloss-retention of silorane and dimethacrylate composites with accelerated aging. J Dent. 2008 Nov;36(11):945-52. doi: 10.1016/j.jdent.2008.08.001. Epub 2008 Sep 7.
- Background: PubMed 16725190He Z, Shimada Y, Tagami J. The effects of cavity size and incremental technique on micro-tensile bond strength of resin composite in Class I cavities. Dent Mater. 2007 May;23(5):533-8. doi: 10.1016/j.dental.2006.03.012. Epub 2006 May 24.
- Background: PubMed 23707645Ilie N, Kessler A, Durner J. Influence of various irradiation processes on the mechanical properties and polymerisation kinetics of bulk-fill resin based composites. J Dent. 2013 Aug;41(8):695-702. doi: 10.1016/j.jdent.2013.05.008. Epub 2013 May 21.
- Background: PubMed 17532918Jefferies SR. Abrasive finishing and polishing in restorative dentistry: a state-of-the-art review. Dent Clin North Am. 2007 Apr;51(2):379-97, ix. doi: 10.1016/j.cden.2006.12.002.
- Background: PubMed 10666968Kohler B, Rasmusson CG, Odman P. A five-year clinical evaluation of Class II composite resin restorations. J Dent. 2000 Feb;28(2):111-6. doi: 10.1016/s0300-5712(99)00059-7.
- Background: PubMed 26850844Munchow EA, Sedrez-Porto JA, Piva E, Pereira-Cenci T, Cenci MS. Use of dental adhesives as modeler liquid of resin composites. Dent Mater. 2016 Apr;32(4):570-7. doi: 10.1016/j.dental.2016.01.002. Epub 2016 Feb 3.
- Background: PubMed 22666829Nahsan FP, Mondelli RF, Franco EB, Naufel FS, Ueda JK, Schmitt VL, Baseggio W. Clinical strategies for esthetic excellence in anterior tooth restorations: understanding color and composite resin selection. J Appl Oral Sci. 2012 Mar-Apr;20(2):151-6. doi: 10.1590/s1678-77572012000200005.
- Background: PubMed 15125602Rees JS, Jagger DC, Williams DR, Brown G, Duguid W. A reappraisal of the incremental packing technique for light cured composite resins. J Oral Rehabil. 2004 Jan;31(1):81-4. doi: 10.1046/j.0305-182x.2003.01073.x.
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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.
Mostafa Abdelhamid, Professor-Cairo University study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Modeling Resin Insertion Technique and Conventional resin composite Incremental Placement Technique in people with Class I Composite Restorations, run by Cairo 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 7 inclusion and 9 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 6 Apr 2023. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amira Mohamed, BDS, MSA University (2017) (01007615913, amira_mohamed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Marginal Discoloration at 3,6,12 & 18 months (time frame: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 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 NCT05801458, which also lists 19 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 6 Apr 2023.