Clinical trial NCT04463342: Evaluation of Clinical Performance for Recent Non Coated Glass Ionomer in Posterior Teeth
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Occlusal Caries
Keywords: Occlusal Caries
Glass Ionomer
Tooth colored Restoration
Non-Coated Glass Ionomer
Universal Glass Ionomer
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Occlusal Caries in Posterior teeth
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Distance penetrated by the Explorer at the tooth restoration interface
timeFrame: during procedure
measure: Distance penetrated by the Explorer at the tooth restoration interface
timeFrame: 3 months
measure: Distance penetrated by the Explorer at the tooth restoration interface
timeFrame: 6 months
measure: Distance penetrated by the Explorer at the tooth restoration interface
timeFrame: 12 months
measure: The degree of mismatch from the normal range of tooth shades and translucency
timeFrame: during procedure
measure: The degree of mismatch from the normal range of tooth shades and translucency
timeFrame: 3 months
measure: The degree of mismatch from the normal range of tooth shades and translucency
timeFrame: 6 months
measure: The degree of mismatch from the normal range of tooth shades and translucency
timeFrame: 12 months
measure: Distance penetrated along the restoration in a pulpal direction
timeFrame: during procedure
measure: Distance penetrated along the restoration in a pulpal direction
timeFrame: 3 months
measure: Distance penetrated along the restoration in a pulpal direction
timeFrame: 6 months
measure: Distance penetrated along the restoration in a pulpal direction
timeFrame: 12 months
measure: Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins
timeFrame: during procedure
measure: Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins
timeFrame: 3 months
measure: Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins
timeFrame: 6 months
measure: Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins
timeFrame: 12 months
measure: Area of continuous movement of an explorer across the surface of the restoration
timeFrame: during procedure
measure: Area of continuous movement of an explorer across the surface of the restoration
timeFrame: 3 months
measure: Area of continuous movement of an explorer across the surface of the restoration
timeFrame: 6 months
measure: Area of continuous movement of an explorer across the surface of the restoration
timeFrame: 12 months
measure: 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.
timeFrame: during procedure
measure: 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.
timeFrame: 3 months
measure: 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.
timeFrame: 6 months
measure: 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.
timeFrame: 12 months
measure: Pain due to dentin hypersensitivity (evaporative stimulus)
timeFrame: during procedure
measure: Pain due to dentin hypersensitivity (evaporative stimulus)
timeFrame: 3 months
measure: Pain due to dentin hypersensitivity (evaporative stimulus)
timeFrame: 6 months
measure: Pain due to dentin hypersensitivity (evaporative stimulus)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: Manial
Study officials:
affiliation: Cairo University
name: Mahmoud M Eldamanhoury, Master
role: PRINCIPAL_INVESTIGATOR
References: