The Effect of Bulk Filling Flowable Composite on Caries Recurrence in Deep Marginal Elevation: a Randomized Clinical Trial

NCT ID: NCT06900868

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-20
• Study Completion Date: 2026-04-20

Brief Summary

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).

Conditions

DME; Dental Caries; Dental; Deep Margin Elevation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

arm

Beautifil-Bulk Flowable Deep margin elevation and subsequent restoration will be done using bioactive goimer material

Group Type: ACTIVE_COMPARATOR

Assigned Interventions

Intervention Type: OTHER

SDR Smart dentine replacement material nonbioactive

Interventions

Assigned Interventions

SDR Smart dentine replacement material nonbioactive

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Future University in Egypt

OTHER

Sponsor Role: lead

Responsible Party

AHMED AYMAN ESMAIL MAHMOUD

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

AHMED A Yakop, BDS

Role: CONTACT

Ahmed.yakop66@Gmail.com

00201555134512

References

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.

Reference Type: BACKGROUND

PMID: 38003997 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35656656 (View on PubMed)

Other Identifiers

Deep marginal elevation

Identifier Type: -

Identifier Source: org_study_id