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

NCT06900868 | Not Yet Recruiting DMC

• 1 other identifier: Deep marginal elevation
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Keywords

Deep margin elevation

Outcome Measures

Primary Outcomes (1)

• Recurrent caries

  * 0: no evidence of caries continuous along the margin using periapical radiograph. * 1: caries evident continuous with the margin of restoration

  T0: 1 Week Baseline T1: 6 Months T2: 12 Months

Secondary Outcomes (3)

• Fracture of Restoration

  T0: 1 Week Baseline T1: 6 Months T2: 12 Months

• Post- operative sensitivity

  T0: 1 Week Baseline T1: 6 Months T2: 12 Months

• Bleeding on Probing

  T0: 1 Week Baseline T1: 6 Months T2: 12 Months

Study Arms (1)

arm

ACTIVE COMPARATOR

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

Other: Assigned Interventions

Interventions

Assigned Interventions OTHER

SDR Smart dentine replacement material nonbioactive

arm

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Future University in Egypt: lead

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

AHMED A Yakop, BDS

CONTACT

00201555134512; Ahmed.yakop66@Gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 22, 2025
• First Posted: March 28, 2025
• Study Start: March 20, 2025
• Primary Completion: April 20, 2026
• Study Completion: April 20, 2026
• Last Updated: March 28, 2025

Record last verified: 2025-03