Clinical trial NCT06097143: Clinical Performance of Flowable Giomer Versus Nanofilled Composite in Conservative Occlusal Cavities
Official title: Performance of Flowable Giomer Versus Nanofilled Flowable Composite With or Without Giomer Coat In Conservative Occlusal Cavities: 18 Months Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Occlusal Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 35
Sex: ALL
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: With limited evidence-based information in literature the goal of this clinical trial is to learn about Flowable Giomer and compare it to Nanofilled Flowable Composite in Conservative Occlusal Cavities. It is beneficial to evaluate the newly introduced material using a randomized controlled clinical trial to test the null hypothesis that this new flowable giomer (Shofu™ Beautifil Injectable X, Shofu Dental Corp., Japan) and conventional resin-based nano-filled composite (Filtek™ Z350 XT 3M ESPE, USA) which will then be coated with (Shofu™ PRG Barrier Coat, Shofu Dental Corp., Japan) will have the same clinical performance as flowable resin composite as a preventative restorative restoration in permanent molars.

Detailed description: This study will be conducted to clinically evaluate caries prevention and marginal integrity of flowable giomer and flowable resin composite coated with S-PRG in comparison to flowable resin composite as a preventative resin restoration in patients requiring minimally invasive simple class I cavities in permanent molars over 18 months test period.

Teeth that meet the inclusion criteria will be selected. The occlusal surfaces will be cleaned by pumice and a low speed polishing brush. Baseline recording of carious lesions will be carried out using DIAGNOdent pen. Cavity preparation will be carried out using number 330 (Mani, Inc., Japan) bur.

All the tested materials Shofu™ Beautifil Injectable X, (Shofu Dental Corp., Japan flowable composite) and Filtek™ Z350 XT (3M ESPE, USA) Flowable composite: Conventional resin-based nano-filled flowable composite which will then be coated with Shofu™ PRG Barrier Coat, (Shofu Dental Corp., Japan) will be used according to manufacturer instructions and comparator restorative material Filtek™ Z350 XT (3M ESPE, USA) Flowable composite.

All restorations will be finished using flame-shaped finishing stone (Mani, Inc., Japan) and polished using rubber cups (Kerr Corporation, Orange, CA, USA).

The primary and secondary outcomes will be measured at four intervals 1 week after placement, 6 months follow up, 12 months follow up and 18 months follow up.

Eligibility criteria: Inclusion Criteria:

* Unilateral or Bilateral small Class I carious lesions
* Patients with good oral health
* Small Class I carious lesion in occlusal pits and fissures

Exclusion Criteria:

* Existing systemic diseases
* Severe medical complications
* Allergy history concerning methacrylates
* Pregnancy
* Heavy smoking
* Evidence of severe bruxism, clenching or temporomandibular joint disorders
* Presence of existing occlusal restoration
* Periapical or pulpal pathology
* Tooth hypersensitivity
* Possible prosthodontic restoration of teeth
* Endodontically treated teeth
* Severe periodontal affection

Primary outcomes:
measure: Fracture and Retention of Material
timeFrame: T0= 1 week postoperative T1= 6 months follow up T2= 12 months follow up T3= 18 months follow up
Secondary outcomes:
measure: Occlusion and wear
timeFrame: T0= 1 week postoperative T1= 6 months follow up T2= 12 months follow up T3= 18 months follow up
measure: Marginal Adaptation
timeFrame: T0= 1 week postoperative T1= 6 months follow up T2= 12 months follow up T3= 18 months follow up
measure: Form and contour
timeFrame: T0= 1 week postoperative T1= 6 months follow up T2= 12 months follow up T3= 18 months follow up
measure: Dental hard tissue defects at restoration margins
timeFrame: T0= 1 week postoperative T1= 6 months follow up T2= 12 months follow up T3= 18 months follow up
measure: Postoperative hypersensitivity/pulp status
timeFrame: T0= 1 week postoperative T1= 6 months follow up T2= 12 months follow up T3= 18 months follow up
measure: Incidence of new carious lesions
timeFrame: T0= 1 week postoperative T1= 6 months follow up T2= 12 months follow up T3= 18 months follow up
Other outcomes:
Locations:
Study officials:
References:
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