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

Occlusal Caries Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04463342
• Other study ID #: CairoU-MMEldamanhoury
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: September 3, 2019
• Est. completion date: February 10, 2021

Study information

• Verified date: June 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: February 10, 2021
• Est. primary completion date: January 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 40 Years

Eligibility

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:

1. Patients with poor oral hygiene. According to DMF or ADA criteria.

2. The presence of any para functional habit.

3. Abnormal occlusion.

4. Any regurgitation problem.

5. Subjects with compromised medical history.

6. Pulpitis, non-vital or endodontically treated teeth.

Related Conditions & MeSH terms

• Occlusal Caries

Intervention

Combination Product:
• Non Coated Glass Ionomer
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.
• Conventional Glass Ionomer with Coat
Conventional Glass Ionomer with Coat

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo	Manial

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance penetrated by the Explorer at the tooth restoration interface	The explorer will be drawn across the surface of the restoration toward the tooth	during procedure
Primary	Distance penetrated by the Explorer at the tooth restoration interface	The explorer will be drawn across the surface of the restoration toward the tooth	3 months
Primary	Distance penetrated by the Explorer at the tooth restoration interface	The explorer will be drawn across the surface of the restoration toward the tooth	6 months
Primary	Distance penetrated by the Explorer at the tooth restoration interface	The explorer will be drawn across the surface of the restoration toward the tooth	12 months
Primary	The degree of mismatch from the normal range of tooth shades and translucency	Visual inspection to check the proximity of the shade from the natural tooth	during procedure
Primary	The degree of mismatch from the normal range of tooth shades and translucency	Visual inspection to check the proximity of the shade from the natural tooth	3 months
Primary	The degree of mismatch from the normal range of tooth shades and translucency	Visual inspection to check the proximity of the shade from the natural tooth	6 months
Primary	The degree of mismatch from the normal range of tooth shades and translucency	Visual inspection to check the proximity of the shade from the natural tooth	12 months
Primary	Distance penetrated along the restoration in a pulpal direction	Visual Inspection of the marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure	during procedure
Primary	Distance penetrated along the restoration in a pulpal direction	Visual Inspection of the marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure	3 months
Primary	Distance penetrated along the restoration in a pulpal direction	Visual Inspection of the marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure	6 months
Primary	Distance penetrated along the restoration in a pulpal direction	Visual Inspection of the marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure	12 months
Primary	Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins	Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time	during procedure
Primary	Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins	Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time	3 months
Primary	Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins	Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time	6 months
Primary	Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins	Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time	12 months
Primary	Area of continuous movement of an explorer across the surface of the restoration	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	during procedure
Primary	Area of continuous movement of an explorer across the surface of the restoration	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	3 months
Primary	Area of continuous movement of an explorer across the surface of the restoration	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	6 months
Primary	Area of continuous movement of an explorer across the surface of the restoration	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	12 months
Primary	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.	Visual inspection and explorer to check the shape and structure of the restoration	during procedure
Primary	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.	Visual inspection and explorer to check the shape and structure of the restoration	3 months
Primary	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.	Visual inspection and explorer to check the shape and structure of the restoration	6 months
Primary	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.	Visual inspection and explorer to check the shape and structure of the restoration	12 months
Primary	Pain due to dentin hypersensitivity (evaporative stimulus)	Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale	during procedure
Primary	Pain due to dentin hypersensitivity (evaporative stimulus)	Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale	3 months
Primary	Pain due to dentin hypersensitivity (evaporative stimulus)	Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale	6 months
Primary	Pain due to dentin hypersensitivity (evaporative stimulus)	Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale	12 months