Marginal DiscolorationNCT07618013
A Two-year Study Evaluating the Surface-sealed Cervical Resin Composite Restorations in Comparison With the Non-sealed Restorations
A study testing PermaSeal™, Ultradent Products Inc., USA, OPTIGLAZE™, GC, Tokyo, Japan and Conventional finishing and polishing protocol in people with Marginal Discoloration and Color Stability, run by Cairo University.
Trial summary
After finishing and polishing are completed, the tooth surface may exhibit microcracks and micro-irregularities that create a roughened surface, which may lead to plaque retention, gingival inflammation, and discoloration. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Marginal Discoloration, Color Stability
- What is being tested?
- PermaSeal™, Ultradent Products Inc., USA, OPTIGLAZE™, GC, Tokyo, Japan and Conventional finishing and polishing protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- No healthy volunteers
- Adult
Participant Inclusion Criteria:
- Adult patients aged 18-55 years.
- Patients with good oral hygiene (mild to moderate plaque accumulation).
- Patients with asymptomatic class V cavities in permanent teeth.
Teeth inclusion criteria:
- Vital posterior teeth with class V carious cavities.
- Moderate cavities (ICDAS 3 \& 4).
- Free from signs and symptoms of irreversible pulpitis and pulpal necrosis.
- Teeth with no or grade 1 mobility.
Participant Exclusion Criteria:
- Patients who are unable to return for recall appointments.
- Patients with poor oral hygiene.
- Presence of abnormal oral, medical, or mental condition
- Presence of any parafunctional habits.
- Patients with TMJ problems.
Teeth Exclusion Criteria:
- Periodontal disease that may affect the prognosis of the restoration or the tooth itself.
- Fractured or visibly cracked teeth.
- Presence of any developmental or formative defects.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Effectiveness of Using Surface Sealants on Cervical Resin Composite Restorations in Comparison With Non-sealed Restorations: A 2-year Randomized Clinical Trial
After finishing and polishing are completed, the tooth surface may exhibit microcracks and micro-irregularities that create a roughened surface, which may lead to plaque retention, gingival inflammation, and discoloration. The surface-penetrating sealant was introduced to fill micro-irregularities by capillary action, providing a uniform, regular surface and enhancing the surface smoothness. The application of unfilled low-viscosity surface sealants aims to enhance the luster, smoothness, and color stability of esthetic restorations and decrease stain absorption. They have low viscosity that enables them to easily spread and penetrate over these finished and polished surfaces, which may affect the life of the restoration positively. Additionally, it decreases surface porosity and creates a surface that is more thoroughly cured, improving the composite's stain resistance.
This prospective, parallel-group, randomized clinical study aims to compare the clinical effectiveness of using surface sealants on cervical resin composite restorations versus non-sealed restorations. Restorations will be assessed at baseline, 6, 12, 18, and 24 months using modified USPHS criteria. The primary outcome will be assessing marginal discoloration, and the secondary outcomes will be assessing color match, secondary caries, postoperative sensitivity, surface texture, and marginal adaptation. Color stability will be assessed by VITA Easyshade®.
- Conditions
- Marginal Discoloration, Color Stability
- Being tested
- PermaSeal™, Ultradent Products Inc., USA, OPTIGLAZE™, GC, Tokyo, Japan, Conventional finishing and polishing protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PermaSeal™, Ultradent Products Inc., USAOther
Unfilled resin surface sealant
OPTIGLAZE™, GC, Tokyo, JapanOther
Unfilled resin surface sealant
Conventional finishing and polishing protocolOther
Restorations without resin surface sealants.
| Study group | Role | What they receive |
|---|---|---|
| Unfilled resin surface sealant group | Experimental | Patients with carious cervical lesions (class V) in the esthetic zone receiving resin composite restorations covered by the Unfilled resin surface sealant Receives: Other: PermaSeal™, Ultradent Products Inc., USA |
| Nano-filled resin surface sealant group | Experimental | Patients with carious cervical lesions (class V) in the esthetic zone receiving resin composite restorations covered by the Nano-filled resin surface sealant Receives: Other: OPTIGLAZE™, GC, Tokyo, Japan |
| Class V Restorations without resin surface sealants. | Active comparator | Patients with carious cervical lesions (class V) in the esthetic zone receiving resin composite restorations not covered by the resin surface sealant Receives: Other: Conventional finishing and polishing protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal discoloration
Modified USPHS criteria
Measured: 2 years
Secondary outcomes (2)
Color match, Secondary caries, Postoperative sensitivity, Surface texture , Marginal adaptation
Modified USPHS criteria
Measured: 2 years
Color stability
by VITA Easyshade®
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Marginal DiscolorationStudies 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nanees Ayman Hassan Aly, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618013
- Sponsor's protocol ID
- Surface sealants on composite
- Status last verified
- May 2026
- First submitted
- 24 May 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision regarding sharing of individual participant data (IPD) has not yet been finalized.
Publications
• Amin, A. H., Yaakob, M. H., Nasir, W. Z. W., & Al-Kadhim, A. H. A. (2018). Evaluation the correlation between age, gender, and the incidence of cervical lesions. Journal of Clinical Research in Dentistry, 1(1). • Attia, R. M., Sobhy, E. M., & Abd El Hameed, M. E. S. (2023). Micro-Hardness and Surface Roughness of Bulk-Fill Composite Resin: Effect of Surface Sealant Application and Two Bleaching Regimens. European Journal of General Dentistry, 12(03), 169-176. • Calazans, F. S., Ferreira, T. D. M. J., Ñaupari-Villasante, R., Mendonça, R. P., Ornellas, G., Albuquerque, E. G., ... & Loguercio, A. D. (2024). Influence of surface sealants on the quality of posterior restorations with bulk-fill composites: A 4-year randomized clinical trial. Dental Materials, 40(3), 466-476. • Dawoud, B., Abou-Auf, E., & Shaalan, O. (2025). 24-Month clinical evaluation of cervical restorations bonded using radio-opaque universal adhesive compared to conventional universal adhesive in carious cervical lesions: A randomized clinical trial. Scientific Reports, 15(1), 5505. • Demarco, F. F., Collares, K., Coelho-de-Souza, F. H., Correa, M. B., Cenci, M. S., Moraes, R. R., & Opdam, N. J. (2015). Anterior composite restorations: A systematic review on long-term survival and reasons for failure. Dental materials, 31(10), 1214-1224. • de Melo Soares, V., de Oliveira Bomfim, H. L. Q., Romão, D. A., de Moraes Porto, I. C. C., & de Mendonça Fragoso, L. S. (2024). Comparative Analysis of Different Methods of Marginal Microleakage Evaluation for Restored Teeth by Composite Resin. Journal of Health Sciences, 26(4), 221-225. • Elwassefy, N., ElEmbaby, A., & Elkholany, N. (2023). Correlation between surface roughness and color stability of nano-and micro-hybrid resin composites using different surface treatment protocols. Egyptian Dental Journal, 69(1), 705-713.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Using Surface Sealants on Cervical Resin Composite Restorations in Comparison With Non-sealed Restorations: A 2-year Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07618013
- Acronym / sponsor ID
- Surface sealants on composite
- Conditions
- Marginal Discoloration, Color Stability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 1 Jun 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.
After finishing and polishing are completed, the tooth surface may exhibit microcracks and micro-irregularities that create a roughened surface, which may lead to plaque retention, gingival inflammation, and discoloration. The surface-penetrating sealant was introduced to fill micro-irregularities by capillary action, providing a uniform, regular surface and enhancing the surface smoothness. The application of unfilled low-viscosity surface sealants aims to enhance the luster, smoothness, and color stability of esthetic restorations and decrease stain absorption. They have low viscosity that enables them to easily spread and penetrate over these finished and polished surfaces, which may affect the life of the restoration positively. Additionally, it decreases surface porosity and creates a surface that is more thoroughly cured, improving the composite's stain resistance.
This prospective, parallel-group, randomized clinical study aims to compare the clinical effectiveness of using surface sealants on cervical resin composite restorations versus non-sealed restorations. Restorations will be assessed at baseline, 6, 12, 18, and 24 months using modified USPHS criteria. The primary outcome will be assessing marginal discoloration, and the secondary outcomes will be assessing color match, secondary caries, postoperative sensitivity, surface texture, and marginal adaptation. Color stability will be assessed by VITA Easyshade®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unfilled resin surface sealant group | Experimental | Other: PermaSeal™, Ultradent Products Inc., USAPatients with carious cervical lesions (class V) in the esthetic zone receiving resin composite restorations covered by the Unfilled resin surface sealant |
| Nano-filled resin surface sealant group | Experimental | Other: OPTIGLAZE™, GC, Tokyo, JapanPatients with carious cervical lesions (class V) in the esthetic zone receiving resin composite restorations covered by the Nano-filled resin surface sealant |
| Class V Restorations without resin surface sealants. | Active comparator | Other: Conventional finishing and polishing protocolPatients with carious cervical lesions (class V) in the esthetic zone receiving resin composite restorations not covered by the resin surface sealant |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| PermaSeal™, Ultradent Products Inc., USAUnfilled resin surface sealant | Other | Unfilled resin surface sealant group |
| OPTIGLAZE™, GC, Tokyo, JapanUnfilled resin surface sealant | Other | Nano-filled resin surface sealant group |
| Conventional finishing and polishing protocolRestorations without resin surface sealants. | Other | Class V Restorations without resin surface sealants. |
Primary outcome
Marginal discoloration
Time frame: 2 years
Modified USPHS criteria
2 secondary outcomes
Color match, Secondary caries, Postoperative sensitivity, Surface texture , Marginal adaptation
Time frame: 2 years
Color stability
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Background• Amin, A. H., Yaakob, M. H., Nasir, W. Z. W., & Al-Kadhim, A. H. A. (2018). Evaluation the correlation between age, gender, and the incidence of cervical lesions. Journal of Clinical Research in Dentistry, 1(1). • Attia, R. M., Sobhy, E. M., & Abd El Hameed, M. E. S. (2023). Micro-Hardness and Surface Roughness of Bulk-Fill Composite Resin: Effect of Surface Sealant Application and Two Bleaching Regimens. European Journal of General Dentistry, 12(03), 169-176. • Calazans, F. S., Ferreira, T. D. M. J., Ñaupari-Villasante, R., Mendonça, R. P., Ornellas, G., Albuquerque, E. G., ... & Loguercio, A. D. (2024). Influence of surface sealants on the quality of posterior restorations with bulk-fill composites: A 4-year randomized clinical trial. Dental Materials, 40(3), 466-476. • Dawoud, B., Abou-Auf, E., & Shaalan, O. (2025). 24-Month clinical evaluation of cervical restorations bonded using radio-opaque universal adhesive compared to conventional universal adhesive in carious cervical lesions: A randomized clinical trial. Scientific Reports, 15(1), 5505. • Demarco, F. F., Collares, K., Coelho-de-Souza, F. H., Correa, M. B., Cenci, M. S., Moraes, R. R., & Opdam, N. J. (2015). Anterior composite restorations: A systematic review on long-term survival and reasons for failure. Dental materials, 31(10), 1214-1224. • de Melo Soares, V., de Oliveira Bomfim, H. L. Q., Romão, D. A., de Moraes Porto, I. C. C., & de Mendonça Fragoso, L. S. (2024). Comparative Analysis of Different Methods of Marginal Microleakage Evaluation for Restored Teeth by Composite Resin. Journal of Health Sciences, 26(4), 221-225. • Elwassefy, N., ElEmbaby, A., & Elkholany, N. (2023). Correlation between surface roughness and color stability of nano-and micro-hybrid resin composites using different surface treatment protocols. Egyptian Dental Journal, 69(1), 705-713.
- Individual participant dataSharing planned: Undecided. The decision regarding sharing of individual participant data (IPD) has not yet been finalized.
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.
Questions about this trial
What is this clinical trial studying?
A study testing PermaSeal™, Ultradent Products Inc., USA, OPTIGLAZE™, GC, Tokyo, Japan and Conventional finishing and polishing protocol in people with Marginal Discoloration and Color Stability, 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?
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: opening soon, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nanees Ayman Hassan Aly (01210974750, nanees.ayman@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal discoloration (time frame: 2 years). 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 NCT07618013, which also lists 1 linked publication.
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 5 Jun 2026; AzTrials last refreshed its copy on 28 Oct 2026.