NCT05125900

Brief Summary

This study was designed to evaluate and compare the 3-year periodontal responses and clinical performance of proximal subgingival open sandwich restorations using three different glass ionomer-based restorative materials and flowable composite.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 18, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

July 14, 2023

Status Verified

July 1, 2023

Enrollment Period

2 years

First QC Date

November 8, 2021

Last Update Submit

July 12, 2023

Conditions

Dental Restoration Failure of Marginal Integrity

Keywords

Deep margin elevationProximal box elevationOpen sandwich techniqueBi-layered restorationsSubgingival cervical margin

Outcome Measures

Primary Outcomes (2)

  • Percentage of patients with periodontal problems

    The periodontal situation of patients were examined based on bleeding on probing, plaque index and probing depth scores

    3 years after restoration

  • Percentage of aesthetic, functional and biological properties for each base material restorations

    Percentage of aesthetic, functional and biological properties were clinically assessed using World Dental Federation parameters for each base material group

    3 years after restoration

Secondary Outcomes (1)

  • Radiographic examination

    3 years after restoration

Study Arms (4)

Resin modified glass ionomer

ACTIVE COMPARATOR

Group received proximal box elevation using resin modified glass ionomer

Other: Proximal box elevation using one of the tested materials

Glass hybrid

PLACEBO COMPARATOR

Group received proximal box elevation using glass hybrid

Other: Proximal box elevation using one of the tested materials

Bulk fill flowable resin composite

ACTIVE COMPARATOR

Group received proximal box elevation using bulk fill flowable resin composite

Other: Proximal box elevation using one of the tested materials

Ion-releasing material

PLACEBO COMPARATOR

Group received proximal box elevation using ion-releasing material

Other: Proximal box elevation using one of the tested materials

Interventions

Proximal box elevation using one of the tested materialsOTHER

Each patient randomly received deep proximal margin elevation with one of the tested restorative materials, while the overlying restorations were all the same regular bulk fill resin composite

Bulk fill flowable resin compositeGlass hybridIon-releasing materialResin modified glass ionomer

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with one proximal sub gingival carious lesion ICDAS 4, or 5 in posterior teeth
  • Patients must have a good oral hygiene;
  • Patients with tooth gives positive response to testing with an electric pulp tester
  • Patients with normal and full occlusion,
  • Patients with opposing teeth should be natural with no restorations.

You may not qualify if:

  • High caries risk patients with extremely poor oral hygiene,
  • Patients involved in orthodontic treatment or periodontal surgery,
  • Patients with periodontally involved teeth (chronic periodontitis)
  • Patients with abutments should be excluded.
  • Patients with heavy bruxism habits and clenching

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry-Mansoura University

Al Mansurah, Dakahliya, 35516, Egypt

Location

Study Officials

  • Hoda S Ismail, Lecturer

    Faculty of Dentistry, Mansoura University, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double (Participant and Investigator)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Each patient received one or two restorations in a posterior tooth on any side randomly selected from the 4 tested restorative materials, all materials were used according to manufacturers' instructions
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2021

First Posted

November 18, 2021

Study Start

January 1, 2020

Primary Completion

January 1, 2022

Study Completion

January 1, 2023

Last Updated

July 14, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

Study Protocol, Statistical Analysis Plan can be shared to other researchers

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be available within 6 Months for 3 years
Access Criteria
for anyone

Locations

EG(1)