NCT07618013

Brief 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. 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®.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
24mo left

Started Jul 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Jul 2026Aug 2028

First Submitted

Initial submission to the registry

May 24, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

June 5, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

May 24, 2026

Last Update Submit

June 4, 2026

Conditions

Marginal DiscolorationColor Stability

Outcome Measures

Primary Outcomes (1)

  • Marginal discoloration

    Modified USPHS criteria

    2 years

Secondary Outcomes (2)

  • Color match, Secondary caries, Postoperative sensitivity, Surface texture , Marginal adaptation

    2 years

  • Color stability

    2 years

Study Arms (3)

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

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

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

Other: Conventional finishing and polishing protocol

Interventions

PermaSeal™, Ultradent Products Inc., USAOTHER

Unfilled resin surface sealant

Unfilled resin surface sealant group
OPTIGLAZE™, GC, Tokyo, JapanOTHER

Unfilled resin surface sealant

Nano-filled resin surface sealant group
Conventional finishing and polishing protocolOTHER

Restorations without resin surface sealants.

Class V Restorations without resin surface sealants.

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • • 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.

    BACKGROUND

MeSH Terms

Interventions

PermaSeal

Central Study Contacts

Nanees Ayman Hassan Aly

CONTACT

01210974750nanees.ayman@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer Assistant, Conservative Dentistry Department, Faculty of Dentistry

Study Record Dates

First Submitted

May 24, 2026

First Posted

June 1, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

June 5, 2026

Record last verified: 2026-05