NCT05614076

Brief Summary

This study aims to compare the clinical performance of conserved chalky white demineralized enamel margins with total removal of demineralized enamel margins in class v cavities restored with composite in patients with acute carious cervical lesions

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

November 4, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 14, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

February 9, 2023

Status Verified

February 1, 2023

Enrollment Period

1.3 years

First QC Date

June 9, 2022

Last Update Submit

February 7, 2023

Conditions

Class V Dental Caries

Outcome Measures

Primary Outcomes (3)

  • marginal discoloration

    ordinal criteria scoring system (ordinal)

    3 months

  • marginal discoloration

    ordinal criteria scoring system (ordinal)

    6 months

  • marginal discoloration

    ordinal criteria scoring system (ordinal)

    12 months

Secondary Outcomes (3)

  • color change

    3 month

  • color change

    6 month

  • color change

    12 month

Study Arms (2)

Conservation of the demineralized chalky white enamel margin of class V cavities

EXPERIMENTAL

for cavity design in this arm we Conserved the demineralized chalky white enamel margin of class V cavities then application of resin composite restoration

Procedure: conserved chalky white enamel margins of class V cavities

Total removal of demineralized enamel margin of class V cavities

ACTIVE COMPARATOR

for cavity design in this arm is Total removal of demineralized enamel margin of class V cavities and restoration with resin composite

Procedure: Total removal of demineralized enamel margins of class V cavities

Interventions

conserved chalky white enamel margins of class V cavitiesPROCEDURE

during cavity preparation, we conserved chalky white enamel margins of class V cavities and then restored them with resin composite restorations,we assessed the restorations with visual inspection using a mirror and explorer according to USPHS Criteria

Conservation of the demineralized chalky white enamel margin of class V cavities
Total removal of demineralized enamel margins of class V cavitiesPROCEDURE

during cavity preparation, we removed the total chalky white enamel margins of class V cavities and then restored them with resin composite restorations, we assessed the restorations with visual inspection using a mirror and explorer according to USPHS Criteria

Total removal of demineralized enamel margin of class V cavities

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • class V carious lesions in premolars and molars.
  • Vital upper or lower teeth with no signs of irreversible pulpitis.
  • Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.

You may not qualify if:

  • Deep carious defects (close to pulp, less than 1 mm distance).
  • Periapical pathology or signs of pulpal pathology.
  • Endodontically treated teeth
  • Tooth hypersensitivity.
  • Possible prosthodontic restoration of teeth.
  • Heavy occlusion or occlusal contacts or history of bruxism.
  • Severe periodontal affection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry, Cairo University

Cairo, 11511, Egypt

RECRUITING

Related Publications (10)

  • Abdalla AI, Garcia-Godoy F. Clinical performance of a self-etch adhesive in Class V restorations made with and without acid etching. J Dent. 2007 Jul;35(7):558-63. doi: 10.1016/j.jdent.2007.02.006. Epub 2007 Apr 27.

    PMID: 17467137BACKGROUND

  • Alexandria AK, Nassur C, Nobrega CBC, Valenca AMG, Rosalen PL, Maia LC. In situ effect of titanium tetrafluoride varnish on enamel demineralization. Braz Oral Res. 2017 Nov 6;31:e86. doi: 10.1590/1807-3107BOR-2017.vol31.0086.

    PMID: 29116298BACKGROUND

  • Bayne SC, Schmalz G. Reprinting the classic article on USPHS evaluation methods for measuring the clinical research performance of restorative materials. Clin Oral Investig. 2005 Dec;9(4):209-14. doi: 10.1007/s00784-005-0017-0. No abstract available.

    PMID: 16421996BACKGROUND

  • Baratieri LN, Ritter AV. Critical appraisal. To bevel or not in anterior composites. J Esthet Restor Dent. 2005;17(4):264-9. doi: 10.1111/j.1708-8240.2005.tb00126.x.

    PMID: 16231497BACKGROUND

  • Chen H, Liu X, Dai J, Jiang Z, Guo T, Ding Y. Effect of remineralizing agents on white spot lesions after orthodontic treatment: a systematic review. Am J Orthod Dentofacial Orthop. 2013 Mar;143(3):376-382.e3. doi: 10.1016/j.ajodo.2012.10.013.

    PMID: 23452972BACKGROUND

  • Kielbassa AM, Ulrich I, Schmidl R, Schuller C, Frank W, Werth VD. Resin infiltration of deproteinised natural occlusal subsurface lesions improves initial quality of fissure sealing. Int J Oral Sci. 2017 Jun;9(2):117-124. doi: 10.1038/ijos.2017.15. Epub 2017 Jun 16.

    PMID: 28621326BACKGROUND

  • Korner P, El Gedaily M, Attin R, Wiedemeier DB, Attin T, Taubock TT. Margin Integrity of Conservative Composite Restorations after Resin Infiltration of Demineralized Enamel. J Adhes Dent. 2017;19(6):483-489. doi: 10.3290/j.jad.a39280.

    PMID: 29152623BACKGROUND

  • Lata S, Varghese NO, Varughese JM. Remineralization potential of fluoride and amorphous calcium phosphate-casein phospho peptide on enamel lesions: An in vitro comparative evaluation. J Conserv Dent. 2010 Jan;13(1):42-6. doi: 10.4103/0972-0707.62634.

    PMID: 20582219BACKGROUND

  • Koc Vural U, Kerimova L, Kiremitci A. Clinical comparison of a micro-hybride resin-based composite and resin modified glass ionomer in the treatment of cervical caries lesions: 36-month, split-mouth, randomized clinical trial. Odontology. 2021 Apr;109(2):376-384. doi: 10.1007/s10266-020-00550-8. Epub 2020 Sep 9.

    PMID: 32902766BACKGROUND

  • Brkanovic S, Ivanisevic A, Miletic I, Mezdic D, Jukic Krmek S. Effect of Nano-Filled Protective Coating and Different pH Enviroment on Wear Resistance of New Glass Hybrid Restorative Material. Materials (Basel). 2021 Feb 5;14(4):755. doi: 10.3390/ma14040755.

    PMID: 33562810BACKGROUND

Central Study Contacts

Maryam Salim Dawood, master

CONTACT

00201011270500maryam.salim@dentistry.cu.edu.eg

Mohamed Refaat El-Bialy, PHD

CONTACT

00201202552666mohamed.refaat@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participant and Outcomes Assessor
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1:1
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
main investigator

Study Record Dates

First Submitted

June 9, 2022

First Posted

November 14, 2022

Study Start

November 4, 2021

Primary Completion

March 1, 2023

Study Completion

May 1, 2023

Last Updated

February 9, 2023

Record last verified: 2023-02

Locations

EG(1)