The Effect of Bulk Filling Flowable Composite on Caries Recurrence in Deep Marginal Elevation: A Randomized Clinical Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Assigned Interventions.
- Who it may be relevant to
- Registry conditions: DME, Dental Caries, Dental, Deep Margin Elevation. Basic parameters: 20 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Deep marginal elevation usinge a bioactive dental material in deep subgingival Class II restorations, S-PRG filler-containing materials offer significant benefits due to their bioactive properties, Their ability to release fluoride, remineralization potential and acid neutralization, reducing the risk of recurrent caries, particularly at the gingival margin(Imazato et al. 2023). The antibacterial and antifungal effects help inhibit biofilm formation, enhancing the longevity of restorations. Additionally, these materials support better marginal adaptation by reducing microleakage and improving bond durability (Imazato et al. 2023) This type of composite may improve the outcomes of deep subgingival margin elevation, benefiting both restorative success and periodontal health(Imazato et al. 2023).
Interventions
- Other Assigned Interventions
SDR Smart dentine replacement material nonbioactive
Primary outcome measures
- Recurrent caries [Time frame: T0: 1 Week Baseline T1: 6 Months T2: 12 Months]
Secondary outcome measures (3)
- Fracture of Restoration [Time frame: T0: 1 Week Baseline T1: 6 Months T2: 12 Months]
- Post- operative sensitivity [Time frame: T0: 1 Week Baseline T1: 6 Months T2: 12 Months]
- Bleeding on Probing [Time frame: T0: 1 Week Baseline T1: 6 Months T2: 12 Months]
Eligibility criteria
Inclusion criteria
- Adults patients (20-50)
- Good oral hygiene (plaque index 0 or 1 )
- Patient approving to participate in the study
- Absence of parafunctional habits and/or bruxism
- No sign of irreversible pulpitis
- No periapical radiolucency
- Deep subgingival margin
- Molars class II with subgingival margin
Exclusion criteria
- • Patients with known allergic or adverse reaction to the tested materials.
- Systematic disease that may affect participation.
- Xerostomic patients.
- Bad oral hygiene (plaque index 2 or 3 )
- Heavy smokers
- Patients undergoing or will start orthodontic treatment
- Patients with removable prothesis
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Felemban MF, Khattak O, Alsharari T, Alzahrani AH, Ganji KK, Iqbal A. Relationship between Deep Marginal Elevation and Periodontal Parameters: A Systematic Review. Medicina (Kaunas). 2023 Nov 3;59(11):1948. doi: 10.3390/medicina59111948. PMID 38003997
- Choudhury WR, Nekkanti S. Mechanical Properties of SDR and Biodentine as Dentin Replacement Materials: An In Vitro Study. J Contemp Dent Pract. 2022 Jan 1;23(1):43-48. PMID 35656656
Identifiers
NCT: NCT06900868 · Deep marginal elevation