Shade MatchNCT05623423
Evaluation of Clinical Performance of Class IV Restoration Using Organically Modified Ceramic (OMNOCER) in Comparison to a Methacrylate Based Composite Resin
A study testing (Admira Fusion, Voco GmbH, Germany) and Methacrylate Based Composite in people with Shade Match, run by Cairo University at 1 site in Egypt.
Trial summary
Evaluation of clinical performance of class IV restoration using organically modified ceramic (ORMOCER) in comparison to a Methacrylate Based Composite Resin: A randomized clinical trial Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Shade Match
- What is being tested?
- (Admira Fusion, Voco GmbH, Germany) and Methacrylate Based Composite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Nov 2022to 30 Dec 2023
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- participant:
- Age of patient (18-40) years old.
- Good oral hygiene.
- Teeth:
- Having no active pulpal or periodontal conditions.
- Normal Occlusion.
- Able to return for follow-up assessments as illustrated by the examiners. -
Who cannot join
- participant:
- Patients with Edge-to-Edge occlusion.
- Patients with high caries index.
- Patients with uncontrolled para-functional habits (e.g. bruxism or clenching).
- Patients with inadequate oral hygiene.
- Patients with periodontal or gingival conditions.
Show all 9Show fewer
- Patients with orthodontic appliances.
- Patients with spontaneous pain or sensitivity to percussion
- Pregnant Patients -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Clinical Performance of Class IV Restoration Using Organically Modified Ceramic (OMNOCER) in Comparison to a Methacrylate Based Composite Resin a Randomized Clinical Trial
Evaluation of clinical performance of class IV restoration using organically modified ceramic (ORMOCER) in comparison to a Methacrylate Based Composite Resin: A randomized clinical trial
Read the detailed description
Statement of the problem:
Resin composites have been the most popular material in esthetic dentistry since 1960's. Esthetic restorative material should resemble the natural tooth; in both color match and stability, and should have adequate strength, wear and sealing characteristics
. Longevity of anterior restorations varied in earlier studies depending on the restorative material and cavity class. Involvement of the incisal angle in anterior teeth resulted in accompanied reduction in average survival time. In contrast to class I, II, III and V cavity configurations, class IV restorations are stressed at the incisal angle, posing a challenge to the tooth restoration interface. Because the majority of class IV restorations lack mechanical retention; the tooth-bonded interface faces additional obstacles. In addition, color is one of the most important factors of esthetic restorations, since color change may be due to intrinsic factors as; changes in the filler, matrix and silane coating as well as extrinsic staining; as absorption of stains, chemical reactivity, diet and oral hygiene. But the recent advances in the resin composite restoration in their monomer chemistry, filler type and structure have been continuously developed to improve their mechanical and physical properties.
Rationale:
In order to optimize the properties of the material and facilitate deeper light transmission, manufacturers incorporated an advanced composite filler technology and resin matrix modifications by introducing Organically Modified Ceramics with pure silicate technology showing superior material properties, which was claimed to be better than Methacrylate Based Composite Resin. Moreover, polymerization shrinkage stresses depend on many factors, like composition of resin matrix, quantity of filler and degree of conversion. Ormocer induces polymerization as a result of a matrix of long inorganic silica chains with organic lateral chains. This type of Ormocer enhances aesthetics, color stability, abrasion resistance, and reduces polymerization shrinkage and surface roughness due to the presence of ceramic polysiloxane, which has low degree of polymerization shrinkage (1.25%)
- Conditions
- Shade Match
- Being tested
- (Admira Fusion, Voco GmbH, Germany), Methacrylate Based Composite
- Keywords
- class IV restoration, ORMOCER, methacrylate based composite resin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(Admira Fusion, Voco GmbH, Germany)Other
cavity margins will be extended to the proximal area, incisal edge, facial and lingual surfaces All enamel margins will be beveled at a 45° angle to the external cavosurface.(approximately 0.5-2.0 mm) An impression for the upper anterior teeth will be taken to produce a silicon palatal index The proximal margins of the restorations will be achieved using the Unica anterior matrix teeth will be etched using 37% phosphoric acid gel for 30 s then rinsed with air water for 20 s A single coat of universal bond cured using and LED light curing unit for 10 s Using the chosen enamel shade of the ORMOCER Resin Composite a thin layer (0.5-1 mm) Unica matrix will used to produce the proximal margins of the restorations Contouring, finishing and polishing of the restoration will be done Dental floss and finishing strips will be used Rubber dam will then be removed and occlusion will be checked using an articulating paper
Methacrylate Based CompositeOther
The exact same steps as in the intervention will be done but using the chosen shades of Methacrylate Based Composite Resin. (Ceram.X Spectra ST, Dentsply Sirona, UK)
| Study group | Role | What they receive |
|---|---|---|
| Organically Modified Ceramic (ORMOCER) Resin Composite. | Experimental | (Admira Fusion, Voco GmbH, Germany) Receives: Other: (Admira Fusion, Voco GmbH, Germany) |
| Methacrylate Based Composite | Active comparator | (Ceram.X Spectra ST, Dentsply Sirona, UK) Receives: Other: Methacrylate Based Composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shade match
measured by Modified USPHS
Measured: T1: 1 week (baseline)
Shade match
measured by Modified USPHS
Measured: T2: 3 months
Shade match
measured by Modified USPHS
Measured: T3: 1 year.
Secondary outcomes (3)
a) Retention rate
Modified united states public health service
Measured: T1: 1 week (baseline)
a) Retention rate
Modified united states public health service
Measured: T2: 3 months
a) Retention rate
Modified united states public health service
Measured: T3: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start30 Nov 2022
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Shade MatchStudies 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lilly Assem Mousa Ahmed, Cairo University
- Investigators
- Mostafa Abdulhameed, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623423
- Sponsor's protocol ID
- class IV restoration
- Status last verified
- Dec 2022
- First submitted
- 6 Nov 2022
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Barcellos DC, Batista GR, Silva MA, Pleffken PR, Rangel PM, Fernandes VV Jr, Di Nicolo R, Torres CR. Two-year clinical performance of self-etching adhesive systems in composite restorations of anterior teeth. Oper Dent. 2013 May-Jun;38(3):258-66. doi: 10.2341/11-397-C. Epub 2012 Oct 30.
PubMed 23110580Blum SL, Horn M, Olms C. A comparison of intraoral spectrophotometers-Are there user-specific differences? J Esthet Restor Dent. 2018 Sep;30(5):442-448. doi: 10.1111/jerd.12407. Epub 2018 Aug 25.
PubMed 30144376Cetin AR, Unlu N, Cobanoglu N. A five-year clinical evaluation of direct nanofilled and indirect composite resin restorations in posterior teeth. Oper Dent. 2013 Mar-Apr;38(2):E1-11. doi: 10.2341/12-160-C. Epub 2012 Dec 5.
PubMed 23215545Demirci M, Tuncer S, Sancakli HS, Tekce N, Baydemir C. Five-year Clinical Evaluation of a Nanofilled and a Nanohybrid Composite in Class IV Cavities. Oper Dent. 2018 May/Jun;43(3):261-271. doi: 10.2341/16-358-C. Epub 2018 Mar 13.
PubMed 29533716Frese C, Wohlrab T, Soliman S, Hahn B, Busch C, Babai A, Krastl G, Wolff D. A Multicenter Trial on the Long-term Performance of Direct Composite Buildups in the Anterior Dentition - Survival and Quality Outcome. J Adhes Dent. 2020;22(6):573-580. doi: 10.3290/j.jad.a45514.
PubMed 33491402Gresnigt MM, Kalk W, Ozcan M. Randomized controlled split-mouth clinical trial of direct laminate veneers with two micro-hybrid resin composites. J Dent. 2012 Sep;40(9):766-75. doi: 10.1016/j.jdent.2012.05.010. Epub 2012 Jun 2.
PubMed 22664565Karaman E, Yazici AR, Ozgunaltay G, Ustunkol I, Berber A. Clinical Evaluation of a Silorane- and a Methacrylate-Based Resin Composite in Class II Restorations: 24-Month Results. Oper Dent. 2017 Jul/Aug;42(4):E102-E110. doi: 10.2341/15-286-C.
PubMed 28682704Llena C, Fernandez S, Forner L. Color stability of nanohybrid resin-based composites, ormocers and compomers. Clin Oral Investig. 2017 May;21(4):1071-1077. doi: 10.1007/s00784-016-1850-z. Epub 2016 May 16.
PubMed 27183827Rajeev V, Arunachalam R, Nayar S, Arunima PR, Ganapathy S, Vedam V. "Ormocer an innovative technology": A replacement for conventional cements and veneer? A comparative in vitro analysis. Eur J Dent. 2017 Jan-Mar;11(1):58-63. doi: 10.4103/ejd.ejd_113_16.
PubMed 28435367Ribeiro JS, Peralta SL, Salgado VE, Lund RG. In situ evaluation of color stability and hardness' decrease of resin-based composites. J Esthet Restor Dent. 2017 Sep;29(5):356-361. doi: 10.1111/jerd.12319. Epub 2017 Jul 24.
PubMed 28737281Romero MF, Haddock FJ, Freites AG, Brackett WW, Brackett MG. Restorative Technique Selection in Class IV Direct Composite Restorations: A Simplified Method. Oper Dent. 2016 May-Jun;41(3):243-8. doi: 10.2341/15-158-T. Epub 2016 Feb 26.
PubMed 26919082Ruschel VC, Martins MV, Bernardon JK, Maia HP. Color Match Between Composite Resin and Tooth Remnant in Class IV Restorations: A Case Series. Oper Dent. 2018 Sep/Oct;43(5):460-466. doi: 10.2341/17-132-S. Epub 2018 Mar 16.
PubMed 29547347Sebold M, Lins RBE, Sahadi BO, Santi MR, Martins LRM, Giannini M. Microtensile Bond Strength, Bonding Interface Morphology, Adhesive Resin Infiltration, and Marginal Adaptation of Bulk-fill Composites Placed Using Different Adhesives. J Adhes Dent. 2021 Oct 1;23(5):409-420. doi: 10.3290/j.jad.b2000221.
PubMed 34549924Torres C, Augusto MG, Mathias-Santamaria IF, Di Nicolo R, Borges AB. Pure Ormocer vs Methacrylate Composites on Posterior Teeth: A Double-blinded Randomized Clinical Trial. Oper Dent. 2020 Jul 1;45(4):359-367. doi: 10.2341/19-079-C.
PubMed 32053457van Dijken JW, Pallesen U. Fracture frequency and longevity of fractured resin composite, polyacid-modified resin composite, and resin-modified glass ionomer cement class IV restorations: an up to 14 years of follow-up. Clin Oral Investig. 2010 Apr;14(2):217-22. doi: 10.1007/s00784-009-0287-z. Epub 2009 Jun 6.
PubMed 19504133
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Performance of Class IV Restoration Using Organically Modified Ceramic (OMNOCER) in Comparison to a Methacrylate Based Composite Resin a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05623423
- Acronym / sponsor ID
- class IV restoration
- Conditions
- Shade Match
- Keywords
- class IV restoration, ORMOCER, methacrylate based composite resin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 21 Nov 2022 (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 clinical performance of class IV restoration using organically modified ceramic (ORMOCER) in comparison to a Methacrylate Based Composite Resin: A randomized clinical trial
Detailed description
Statement of the problem:
Resin composites have been the most popular material in esthetic dentistry since 1960's. Esthetic restorative material should resemble the natural tooth; in both color match and stability, and should have adequate strength, wear and sealing characteristics
. Longevity of anterior restorations varied in earlier studies depending on the restorative material and cavity class. Involvement of the incisal angle in anterior teeth resulted in accompanied reduction in average survival time. In contrast to class I, II, III and V cavity configurations, class IV restorations are stressed at the incisal angle, posing a challenge to the tooth restoration interface. Because the majority of class IV restorations lack mechanical retention; the tooth-bonded interface faces additional obstacles. In addition, color is one of the most important factors of esthetic restorations, since color change may be due to intrinsic factors as; changes in the filler, matrix and silane coating as well as extrinsic staining; as absorption of stains, chemical reactivity, diet and oral hygiene. But the recent advances in the resin composite restoration in their monomer chemistry, filler type and structure have been continuously developed to improve their mechanical and physical properties.
Rationale:
In order to optimize the properties of the material and facilitate deeper light transmission, manufacturers incorporated an advanced composite filler technology and resin matrix modifications by introducing Organically Modified Ceramics with pure silicate technology showing superior material properties, which was claimed to be better than Methacrylate Based Composite Resin. Moreover, polymerization shrinkage stresses depend on many factors, like composition of resin matrix, quantity of filler and degree of conversion. Ormocer induces polymerization as a result of a matrix of long inorganic silica chains with organic lateral chains. This type of Ormocer enhances aesthetics, color stability, abrasion resistance, and reduces polymerization shrinkage and surface roughness due to the presence of ceramic polysiloxane, which has low degree of polymerization shrinkage (1.25%)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Organically Modified Ceramic (ORMOCER) Resin Composite. | Experimental | Other: (Admira Fusion, Voco GmbH, Germany)(Admira Fusion, Voco GmbH, Germany) |
| Methacrylate Based Composite | Active comparator | Other: Methacrylate Based Composite(Ceram.X Spectra ST, Dentsply Sirona, UK) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age of patient (18-40) years old.
- Good oral hygiene.
- Having no active pulpal or periodontal conditions.
- Normal Occlusion.
- Able to return for follow-up assessments as illustrated by the examiners. -
Key exclusion criteria (9 listed)
- Patients with Edge-to-Edge occlusion.
- Patients with high caries index.
- Patients with uncontrolled para-functional habits (e.g. bruxism or clenching).
- Patients with inadequate oral hygiene.
- Patients with periodontal or gingival conditions.
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 |
|---|---|---|
| (Admira Fusion, Voco GmbH, Germany)cavity margins will be extended to the proximal area, incisal edge, facial and lingual surfaces All enamel margins will be beveled at a 45° angle to the external cavosurface.(approximately 0.5-2.0 mm) An impression for the upper anterior teeth will be taken to produce a silicon palatal index The proximal margins of the restorations will be achieved using the Unica anterior matrix teeth will be etched using 37% phosphoric acid gel for 30 s then rinsed with air water for 20 s A single coat of universal bond cured using and LED light curing unit for 10 s Using the chosen enamel shade of the ORMOCER Resin Composite a thin layer (0.5-1 mm) Unica matrix will used to produce the proximal margins of the restorations Contouring, finishing and polishing of the restoration will be done Dental floss and finishing strips will be used Rubber dam will then be removed and occlusion will be checked using an articulating paper | Other | Organically Modified Ceramic (ORMOCER) Resin Composite. |
| Methacrylate Based CompositeThe exact same steps as in the intervention will be done but using the chosen shades of Methacrylate Based Composite Resin. (Ceram.X Spectra ST, Dentsply Sirona, UK) | Other | Methacrylate Based Composite |
Primary outcome
Shade match
Time frame: T1: 1 week (baseline)
measured by Modified USPHS
Shade match
Time frame: T2: 3 months
measured by Modified USPHS
Shade match
Time frame: T3: 1 year.
measured by Modified USPHS
3 secondary outcomes
a) Retention rate
Time frame: T1: 1 week (baseline)
a) Retention rate
Time frame: T2: 3 months
a) Retention rate
Time frame: T3: 1 year
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 4 Jun 2024.
- Background: PubMed 23110580Barcellos DC, Batista GR, Silva MA, Pleffken PR, Rangel PM, Fernandes VV Jr, Di Nicolo R, Torres CR. Two-year clinical performance of self-etching adhesive systems in composite restorations of anterior teeth. Oper Dent. 2013 May-Jun;38(3):258-66. doi: 10.2341/11-397-C. Epub 2012 Oct 30.
- Background: PubMed 30144376Blum SL, Horn M, Olms C. A comparison of intraoral spectrophotometers-Are there user-specific differences? J Esthet Restor Dent. 2018 Sep;30(5):442-448. doi: 10.1111/jerd.12407. Epub 2018 Aug 25.
- Background: PubMed 23215545Cetin AR, Unlu N, Cobanoglu N. A five-year clinical evaluation of direct nanofilled and indirect composite resin restorations in posterior teeth. Oper Dent. 2013 Mar-Apr;38(2):E1-11. doi: 10.2341/12-160-C. Epub 2012 Dec 5.
- Background: PubMed 29533716Demirci M, Tuncer S, Sancakli HS, Tekce N, Baydemir C. Five-year Clinical Evaluation of a Nanofilled and a Nanohybrid Composite in Class IV Cavities. Oper Dent. 2018 May/Jun;43(3):261-271. doi: 10.2341/16-358-C. Epub 2018 Mar 13.
- Background: PubMed 33491402Frese C, Wohlrab T, Soliman S, Hahn B, Busch C, Babai A, Krastl G, Wolff D. A Multicenter Trial on the Long-term Performance of Direct Composite Buildups in the Anterior Dentition - Survival and Quality Outcome. J Adhes Dent. 2020;22(6):573-580. doi: 10.3290/j.jad.a45514.
- Background: PubMed 22664565Gresnigt MM, Kalk W, Ozcan M. Randomized controlled split-mouth clinical trial of direct laminate veneers with two micro-hybrid resin composites. J Dent. 2012 Sep;40(9):766-75. doi: 10.1016/j.jdent.2012.05.010. Epub 2012 Jun 2.
- Background: PubMed 28682704Karaman E, Yazici AR, Ozgunaltay G, Ustunkol I, Berber A. Clinical Evaluation of a Silorane- and a Methacrylate-Based Resin Composite in Class II Restorations: 24-Month Results. Oper Dent. 2017 Jul/Aug;42(4):E102-E110. doi: 10.2341/15-286-C.
- Background: PubMed 27183827Llena C, Fernandez S, Forner L. Color stability of nanohybrid resin-based composites, ormocers and compomers. Clin Oral Investig. 2017 May;21(4):1071-1077. doi: 10.1007/s00784-016-1850-z. Epub 2016 May 16.
- Background: PubMed 28435367Rajeev V, Arunachalam R, Nayar S, Arunima PR, Ganapathy S, Vedam V. "Ormocer an innovative technology": A replacement for conventional cements and veneer? A comparative in vitro analysis. Eur J Dent. 2017 Jan-Mar;11(1):58-63. doi: 10.4103/ejd.ejd_113_16.
- Background: PubMed 28737281Ribeiro JS, Peralta SL, Salgado VE, Lund RG. In situ evaluation of color stability and hardness' decrease of resin-based composites. J Esthet Restor Dent. 2017 Sep;29(5):356-361. doi: 10.1111/jerd.12319. Epub 2017 Jul 24.
- Background: PubMed 26919082Romero MF, Haddock FJ, Freites AG, Brackett WW, Brackett MG. Restorative Technique Selection in Class IV Direct Composite Restorations: A Simplified Method. Oper Dent. 2016 May-Jun;41(3):243-8. doi: 10.2341/15-158-T. Epub 2016 Feb 26.
- Background: PubMed 29547347Ruschel VC, Martins MV, Bernardon JK, Maia HP. Color Match Between Composite Resin and Tooth Remnant in Class IV Restorations: A Case Series. Oper Dent. 2018 Sep/Oct;43(5):460-466. doi: 10.2341/17-132-S. Epub 2018 Mar 16.
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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 Abdulhameed, Professor study director
Cairo 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 (Admira Fusion, Voco GmbH, Germany) and Methacrylate Based Composite in people with Shade Match, run by Cairo 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 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: finished, as of the sponsor's last update on 4 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?
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?
Shade match (time frame: T1: 1 week (baseline)). The study lists 3 primary outcomes in all. 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 NCT05623423, which also lists 15 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 4 Jun 2024.