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Completed

NCT Number: NCT04463342

Evaluation of Clinical Performance for Recent Non Coated Glass Ionomer in Posterior Teeth

In patients with occlusal caries in posterior teeth, does the use of recently introduced non coated glass ionomer provide better clinical performance compared to conventional glass ionomer with surface coating?

-Primary objective: To evaluate clinical performance of different types of restorations (Ketac molar with coating and Ketac Universal Aplicap 3M without coating) in occlusal caries in posterior teeth.

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Key information

Conditions

Occlusal Caries

Age range

19 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cairo University

Cairo, Manial, 00202, Egypt

About this study

The study will be conducted in Conservative Dentistry Department, Faculty of Dentistry, Cairo University; The operator in charge will be Mahmoud Magdy Eldamanhory

Patients will be selected from the outpatient clinic of the department Conservative Dentistry Department, Faculty of Dentistry, Cairo University

  • Local anesthesia will be applied to patients complaining about pain or sensitivity to prevent discomfort during restorative procedures.
  • Conservative cavity design will be used according to the principals of minimal invasive dentistry.
  • All the cavities will be performed by the main author using #57 straight plain carbide fissure bur held in high speed contra-angled hand piece with water cooling system.
  • All internal line angles will be slightly rounded.
  • Each bur will be discarded after 5 preparations
  • If deep caries will be found, it will be removed with large round bur at low speed and a thin layer of calcium hydroxide will be placed on the deep portion of the cavity.
  • Isolation will be maintained by using Rubber Dam.
  • The dentin and enamel of cavities will be conditioned with 20% polyacrylic acid for 20 seconds (Cavity Conditioner, GC), washed, and briefly dried.
  • The restorations will inject into the cavity.
  • After the passage of the manufacturer's recommended setting time of 2.5 minutes, the restoration will be trimmed and polished wet using high-speed fine diamonds.

In control group ketac molar with coating:

-After the restoration will briefly dry, Ketac Coat will be applied and photocured for 20 seconds using a photo-curing light.

In study group " Ketac Universal Aplicap 3M without coating":

-The newest addition to glass ionomer family, Ketac Universal Aplicap glass ionomer restorative is a self-cure, one-step placement material designed to help to finish faster. There's no need for conditioning, coating or light-curing steps.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Presence of at least 2 carious class I in same patient.
  • The absence of tooth mobility.
  • Presence of contact with opposite teeth without any abnormal occlusion stress for the selected teeth.
  • Accessible isolation and observable and easily accessible.

Exclusion criteria

  • Patients with poor oral hygiene. According to DMF or ADA criteria.
  • The presence of any para functional habit.
  • Abnormal occlusion.
  • Any regurgitation problem.
  • Subjects with compromised medical history.
  • Pulpitis, non-vital or endodontically treated teeth.

Treatment and study plan

Non Coated Glass Ionomer

Combination Product

KetacTM Universal AplicapTM Glass Ionomer Restorative saves time by eliminating the need for a coating-yet still delivers the compressive strength and surface hardness that are higher than several competitive glass ionomers which require one.

Other names: Ketac Universal Aplicap- Glass Ionomer Restorative

Conventional Glass Ionomer with Coat

Combination Product

Conventional Glass Ionomer with Coat

Primary outcomes

  1. Distance penetrated by the Explorer at the tooth restoration interface

    Time frame: during procedure

    The explorer will be drawn across the surface of the restoration toward the tooth

  2. Distance penetrated by the Explorer at the tooth restoration interface

    Time frame: 3 months

    The explorer will be drawn across the surface of the restoration toward the tooth

  3. Distance penetrated by the Explorer at the tooth restoration interface

    Time frame: 6 months

    The explorer will be drawn across the surface of the restoration toward the tooth

  4. Distance penetrated by the Explorer at the tooth restoration interface

    Time frame: 12 months

    The explorer will be drawn across the surface of the restoration toward the tooth

  5. The degree of mismatch from the normal range of tooth shades and translucency

    Time frame: during procedure

    Visual inspection to check the proximity of the shade from the natural tooth

  6. The degree of mismatch from the normal range of tooth shades and translucency

    Time frame: 3 months

    Visual inspection to check the proximity of the shade from the natural tooth

  7. The degree of mismatch from the normal range of tooth shades and translucency

    Time frame: 6 months

    Visual inspection to check the proximity of the shade from the natural tooth

  8. The degree of mismatch from the normal range of tooth shades and translucency

    Time frame: 12 months

    Visual inspection to check the proximity of the shade from the natural tooth

  9. Distance penetrated along the restoration in a pulpal direction

    Time frame: during procedure

    Visual Inspection of the marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure

  10. Distance penetrated along the restoration in a pulpal direction

    Time frame: 3 months

    Visual Inspection of the marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure

  11. Distance penetrated along the restoration in a pulpal direction

    Time frame: 6 months

    Visual Inspection of the marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure

  12. Distance penetrated along the restoration in a pulpal direction

    Time frame: 12 months

    Visual Inspection of the marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure

  13. Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins

    Time frame: during procedure

    Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time

  14. Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins

    Time frame: 3 months

    Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time

  15. Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins

    Time frame: 6 months

    Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time

  16. Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins

    Time frame: 12 months

    Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time

  17. Area of continuous movement of an explorer across the surface of the restoration

    Time frame: during procedure

    Surface texture is highly polished or gritty containing supramicron-sized particles or Surface pitting is coarse to inhibit the continuous movement of an explorer across the surface

  18. Area of continuous movement of an explorer across the surface of the restoration

    Time frame: 3 months

    Surface texture is highly polished or gritty containing supramicron-sized particles or Surface pitting is coarse to inhibit the continuous movement of an explorer across the surface

  19. Area of continuous movement of an explorer across the surface of the restoration

    Time frame: 6 months

    Surface texture is highly polished or gritty containing supramicron-sized particles or Surface pitting is coarse to inhibit the continuous movement of an explorer across the surface

  20. Area of continuous movement of an explorer across the surface of the restoration

    Time frame: 12 months

    Surface texture is highly polished or gritty containing supramicron-sized particles or Surface pitting is coarse to inhibit the continuous movement of an explorer across the surface

  21. Distance seen when the side of the explorer is placed tangentially across the restoration, by which it is not touching two opposing cavosurface line angles at the same time.

    Time frame: during procedure

    Visual inspection and explorer to check the shape and structure of the restoration

  22. Distance seen when the side of the explorer is placed tangentially across the restoration, by which it is not touching two opposing cavosurface line angles at the same time.

    Time frame: 3 months

    Visual inspection and explorer to check the shape and structure of the restoration

  23. Distance seen when the side of the explorer is placed tangentially across the restoration, by which it is not touching two opposing cavosurface line angles at the same time.

    Time frame: 6 months

    Visual inspection and explorer to check the shape and structure of the restoration

  24. Distance seen when the side of the explorer is placed tangentially across the restoration, by which it is not touching two opposing cavosurface line angles at the same time.

    Time frame: 12 months

    Visual inspection and explorer to check the shape and structure of the restoration

  25. Pain due to dentin hypersensitivity (evaporative stimulus)

    Time frame: during procedure

    Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale

  26. Pain due to dentin hypersensitivity (evaporative stimulus)

    Time frame: 3 months

    Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale

  27. Pain due to dentin hypersensitivity (evaporative stimulus)

    Time frame: 6 months

    Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale

  28. Pain due to dentin hypersensitivity (evaporative stimulus)

    Time frame: 12 months

    Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Evaluation of Clinical Performance for Recently Introduced Non Coated Glass Ionomer in Occlusal Caries in Posterior Teeth Compared to Conventional Glass Ionomer With Coating: A Randomized Clinical Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jul 9, 2020
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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