Early Childhood Caries (ECC)NCT07716033
Aesthetic and Functional Evaluation of a Universal One-Shade Composite in Primary Maxillary Incisors
A study testing Tokuyama Palfique Omnichroma composite restoration and 3M Filtek Z350 composite restoration in people with Early Childhood Caries (ECC), run by Goa Dental College at 1 site in India.
Trial summary
Use of tooth-coloured fillings is an essential part of Pediatric dentistry as most patients desire fillings which look like natural teeth. Lately, there is a vast variety of shade-choices in filling materials which complicates colour matching procedure, increases cost and increases treatment time. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Childhood Caries (ECC)
- What is being tested?
- Tokuyama Palfique Omnichroma composite restoration and 3M Filtek Z350 composite restoration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 1 Mar 2025to 28 Feb 2026
- 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age group of 3-5 years
- Carious lesions in both primary maxillary central incisors involving enamel or enamel and dentin only
- Similar extent of carious lesion in both primary maxillary central incisors
- Willing to give informed consent
- Willing to return for evaluations and follow up
Who cannot join
- Presence of pre shedding mobility
- Deep carious lesions
- Signs or symptoms of pulpal involvement
- Presence of abscess, sinus tract, root resorption
- Highly uncooperative patients
- Medically compromised patients
- Children with special health care needs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Aesthetic and Functional Properties of A Universal One-Shade Composite Material With Chameleon-like Properties: A Longitudinal Split-Mouth Randomised Controlled Trial
- Use of tooth-coloured fillings is an essential part of Pediatric dentistry as most patients desire fillings which look like natural teeth.
- Lately, there is a vast variety of shade-choices in filling materials which complicates colour matching procedure, increases cost and increases treatment time.
- Universal One shade composite filling materials have been developed to overcome these disadvantages. Omnichroma (Tokuyama Dental, USA) is one such material, introduced in 2019.
- Manufacturer claims that it can match colour of surrounding tooth, irrespective of its shade, which may be an advantage for patients as well as pediatric dentists.
- In child patients where chairside time, child's cooperation are important, this new one shade filling material Omnichroma, may prove to be better than multi shade composite filling materials, regarding color matching, color stability and other functional properties.
- There are very few studies on this new material, that have assessed its actual performance in patients, and more studies would be useful to generate scientific evidence for dentists to use.
- In this study we will fill one of your child's decayed front tooth with the new One shade filling material Omnichroma, and the other decayed front tooth with the usual conventional multi shade filling material 3M Filtek Z350 after colour matching followed by evaluation and taking of intraoral photographs.
- You would be required to report for follow ups at 3, 6 and 12 months interval for a repeat evaluation and intraoral pictures.
- Conditions
- Early Childhood Caries (ECC)
- Being tested
- Tokuyama Palfique Omnichroma composite restoration, 3M Filtek Z350 composite restoration
- Keywords
- Omnichroma, Universal one-shade composite, Colour match, Colour stability, Aesthetic, Functional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tokuyama Palfique Omnichroma composite restorationOther
Tokuyama Palfique Omnichroma is a universal one-shade resin composite used for direct restoration of primary maxillary incisors.
3M Filtek Z350 composite restorationOther
3M Filtek Z350 XT is a nanofilled resin composite used as the active comparator for direct restoration of primary maxillary incisors.
| Study group | Role | What they receive |
|---|---|---|
| Universal One-shade composite group | Experimental | Not described Receives: Other: Tokuyama Palfique Omnichroma composite restoration |
| Conventional Multi-shade composite | Active comparator | Not described Receives: Other: 3M Filtek Z350 composite restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface Luster and Surface texture
Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome
Measured: Baseline, 3 months, 6 months, and 12 months
Marginal adaptation
Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome
Measured: Baseline, 3 months, 6 months, 12 months
Marginal staining
Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome
Measured: Baseline, 3 months, 6 months, 12 months
Fracture of material and retention
Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome
Measured: Baseline, 3 months, 6 months, 12 months
Colour match
Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome
Measured: Baseline, 3 months, 6 months, 12 months
Secondary outcomes (2)
Photographic/Digital Colour match
A software was used to provide CIE L*, a*, and b* values for one point over the tooth surface (Pt B) and one point over the restoration (Pt A). The colour match/difference (ΔE) between the restoration (Pt A) and the adjacent tooth structure (Pt B) was calculated using the CIEDE2000 colour difference formula through the software algorithm. Lower ΔE values indicate a smaller colour discrepancy between the restoration and the surrounding tooth structure and were interpreted as better colour matching. Higher ΔE values indicate greater perceptible colour differences.
Measured: Baseline, 3 months, 6 months, 12 months
Photographic/ Digital Colour stability
For the assessment of colour stability, ΔE values obtained at different follow-up intervals were compared over time at baseline (ΔE0), 3 months (ΔE₁), 6 months (ΔE₂) and 12 months (ΔE₃). Small differences in ΔE values across these time points were interpreted as indicating greater colour stability.
Measured: Baseline, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start1 Mar 2025
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Early Childhood Caries (ECC)Studies of the same condition, open and under way.
- 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
- Split-mouth Randomised controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goa Dental College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ruhi Sanvordekar, Goa Dental College
- Investigators
- Ruhi Sanvordekar, MDS, Principal investigator, Goa Dental College and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716033
- Sponsor's protocol ID
- GDCH/IEC/II-2024(18)
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only summary study results will be made publicly available. Individual participant data and participant identifiers will not be shared to maintain confidentiality.
Publications
Bulut S, Sakci Z, Naderi S. Illumination of The Relationship between Ureter and Intervertebral Disc by Computed Tomography. Turk Neurosurg. 2021;31(3):466-471. doi: 10.5137/1019-5149.JTN.32650-20.4.
PubMed 33624284Araujo RLS, Correa JR, Galera PD. Ultrastructural morphology of goblet cells of the conjunctiva of dogs. Vet Ophthalmol. 2019 Nov;22(6):891-897. doi: 10.1111/vop.12667. Epub 2019 Apr 1.
PubMed 30938063Khanfar M, Al-Remawi M, Al-Akayleh F, Hmouze S. Preparation and Evaluation of Co-amorphous Formulations of Telmisartan-Amino Acids as a Potential Method for Solubility and Dissolution Enhancement. AAPS PharmSciTech. 2021 Mar 21;22(3):112. doi: 10.1208/s12249-021-01952-9.
PubMed 33748914Bauer A, Hegen H, Reindl M. Body fluid markers for multiple sclerosis and differential diagnosis from atypical demyelinating disorders. Expert Rev Mol Diagn. 2024 Apr;24(4):283-297. doi: 10.1080/14737159.2024.2334849. Epub 2024 Mar 27.
PubMed 38533708Hoeijmakers A, Licitra G, Meijer K, Lam KH, Molenaar P, Strijbis E, Killestein J. Disease severity classification using passively collected smartphone-based keystroke dynamics within multiple sclerosis. Sci Rep. 2023 Feb 1;13(1):1871. doi: 10.1038/s41598-023-28990-6.
PubMed 36725975de Abreu JLB, Sampaio CS, Benalcazar Jalkh EB, Hirata R. Analysis of the color matching of universal resin composites in anterior restorations. J Esthet Restor Dent. 2021 Mar;33(2):269-276. doi: 10.1111/jerd.12659. Epub 2020 Sep 29.
PubMed 32989879Zulekha, Vinay C, Uloopi KS, RojaRamya KS, Penmatsa C, Ramesh MV. Clinical performance of one shade universal composite resin and nanohybrid composite resin as full coronal esthetic restorations in primary maxillary incisors: A randomized controlled trial. J Indian Soc Pedod Prev Dent. 2022 Apr-Jun;40(2):159-164. doi: 10.4103/jisppd.jisppd_151_22.
PubMed 35859408
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Aesthetic and Functional Properties of A Universal One-Shade Composite Material With Chameleon-like Properties: A Longitudinal Split-Mouth Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07716033
- Acronym / sponsor ID
- GDCH/IEC/II-2024(18)
- Conditions
- Early Childhood Caries (ECC)
- Keywords
- Omnichroma, Universal one-shade composite, Colour match, Colour stability, Aesthetic, Functional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Goa Dental CollegeOther government
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 21 Jul 2026 (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.
- Use of tooth-coloured fillings is an essential part of Pediatric dentistry as most patients desire fillings which look like natural teeth.
- Lately, there is a vast variety of shade-choices in filling materials which complicates colour matching procedure, increases cost and increases treatment time.
- Universal One shade composite filling materials have been developed to overcome these disadvantages. Omnichroma (Tokuyama Dental, USA) is one such material, introduced in 2019.
- Manufacturer claims that it can match colour of surrounding tooth, irrespective of its shade, which may be an advantage for patients as well as pediatric dentists.
- In child patients where chairside time, child's cooperation are important, this new one shade filling material Omnichroma, may prove to be better than multi shade composite filling materials, regarding color matching, color stability and other functional properties.
- There are very few studies on this new material, that have assessed its actual performance in patients, and more studies would be useful to generate scientific evidence for dentists to use.
- In this study we will fill one of your child's decayed front tooth with the new One shade filling material Omnichroma, and the other decayed front tooth with the usual conventional multi shade filling material 3M Filtek Z350 after colour matching followed by evaluation and taking of intraoral photographs.
- You would be required to report for follow ups at 3, 6 and 12 months interval for a repeat evaluation and intraoral pictures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Split-mouth Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Universal One-shade composite group | Experimental | Other: Tokuyama Palfique Omnichroma composite restoration |
| Conventional Multi-shade composite | Active comparator | Other: 3M Filtek Z350 composite restoration |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age group of 3-5 years
- Carious lesions in both primary maxillary central incisors involving enamel or enamel and dentin only
- Similar extent of carious lesion in both primary maxillary central incisors
- Willing to give informed consent
- Willing to return for evaluations and follow up
Key exclusion criteria (7 listed)
- Presence of pre shedding mobility
- Deep carious lesions
- Signs or symptoms of pulpal involvement
- Presence of abscess, sinus tract, root resorption
- Highly uncooperative patients
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 |
|---|---|---|
| Tokuyama Palfique Omnichroma composite restorationTokuyama Palfique Omnichroma is a universal one-shade resin composite used for direct restoration of primary maxillary incisors. | Other | Universal One-shade composite group |
| 3M Filtek Z350 composite restoration3M Filtek Z350 XT is a nanofilled resin composite used as the active comparator for direct restoration of primary maxillary incisors. | Other | Conventional Multi-shade composite |
Primary outcome
Surface Luster and Surface texture
Time frame: Baseline, 3 months, 6 months, and 12 months
Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome
Marginal adaptation
Time frame: Baseline, 3 months, 6 months, 12 months
Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome
Marginal staining
Time frame: Baseline, 3 months, 6 months, 12 months
Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome
Fracture of material and retention
Time frame: Baseline, 3 months, 6 months, 12 months
Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome
Colour match
Time frame: Baseline, 3 months, 6 months, 12 months
Assessed using Revised FDI criteria 2023 Scores from 1-5 Higher scores indicate inferior outcome
2 secondary outcomes
Photographic/Digital Colour match
Time frame: Baseline, 3 months, 6 months, 12 months
Photographic/ Digital Colour stability
Time frame: Baseline, 3 months, 6 months, 12 months
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 21 Jul 2026.
- Background: PubMed 33624284Bulut S, Sakci Z, Naderi S. Illumination of The Relationship between Ureter and Intervertebral Disc by Computed Tomography. Turk Neurosurg. 2021;31(3):466-471. doi: 10.5137/1019-5149.JTN.32650-20.4.
- Background: PubMed 30938063Araujo RLS, Correa JR, Galera PD. Ultrastructural morphology of goblet cells of the conjunctiva of dogs. Vet Ophthalmol. 2019 Nov;22(6):891-897. doi: 10.1111/vop.12667. Epub 2019 Apr 1.
- Background: PubMed 33748914Khanfar M, Al-Remawi M, Al-Akayleh F, Hmouze S. Preparation and Evaluation of Co-amorphous Formulations of Telmisartan-Amino Acids as a Potential Method for Solubility and Dissolution Enhancement. AAPS PharmSciTech. 2021 Mar 21;22(3):112. doi: 10.1208/s12249-021-01952-9.
- Background: PubMed 38533708Bauer A, Hegen H, Reindl M. Body fluid markers for multiple sclerosis and differential diagnosis from atypical demyelinating disorders. Expert Rev Mol Diagn. 2024 Apr;24(4):283-297. doi: 10.1080/14737159.2024.2334849. Epub 2024 Mar 27.
- Background: PubMed 36725975Hoeijmakers A, Licitra G, Meijer K, Lam KH, Molenaar P, Strijbis E, Killestein J. Disease severity classification using passively collected smartphone-based keystroke dynamics within multiple sclerosis. Sci Rep. 2023 Feb 1;13(1):1871. doi: 10.1038/s41598-023-28990-6.
- Background: PubMed 32989879de Abreu JLB, Sampaio CS, Benalcazar Jalkh EB, Hirata R. Analysis of the color matching of universal resin composites in anterior restorations. J Esthet Restor Dent. 2021 Mar;33(2):269-276. doi: 10.1111/jerd.12659. Epub 2020 Sep 29.
- Background: PubMed 35859408Zulekha, Vinay C, Uloopi KS, RojaRamya KS, Penmatsa C, Ramesh MV. Clinical performance of one shade universal composite resin and nanohybrid composite resin as full coronal esthetic restorations in primary maxillary incisors: A randomized controlled trial. J Indian Soc Pedod Prev Dent. 2022 Apr-Jun;40(2):159-164. doi: 10.4103/jisppd.jisppd_151_22.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Only summary study results will be made publicly available. Individual participant data and participant identifiers will not be shared to maintain confidentiality.
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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.
Ruhi Sanvordekar, MDS principal investigator
Goa Dental College and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tokuyama Palfique Omnichroma composite restoration and 3M Filtek Z350 composite restoration in people with Early Childhood Caries (ECC), run by Goa Dental College at 1 site in India.
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 7 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 21 Jul 2026. 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 India. 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?
Surface Luster and Surface texture (time frame: Baseline, 3 months, 6 months, and 12 months). The study lists 5 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 NCT07716033, which also lists 7 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 21 Jul 2026.