NCT05020093

Brief Summary

The clinical performance of 2 bonding and composite packing techniques in the proximal cavities of permanent posterior teeth will be assessed. Incremental packing with pre-curing of universal adhesive in selective etching mode is compared to injection molding of preheated composing co-cured with universal adhesive in selective-etch. Main outcomes will focus on marginal integrity, post-operative hypersensitivity, and contact form and tightness.

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
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2019

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

2 years

First QC Date

August 12, 2021

Last Update Submit

August 18, 2021

Conditions

Caries Class II

Keywords

AdhesionComposite

Outcome Measures

Primary Outcomes (1)

  • Marginal integrity using a 150- and 250- micron width special probe tip

    gap width at tooth-restoration interface

    36 months

Secondary Outcomes (2)

  • Post-Operative hypersensitivity: using Visual Analog Scale 0-10 (VAS). Zero: no pain; 10: unbearable pain.

    48 hours and one week

  • Contact tightness: gap width between proximal teeth surfaces. Using a 25-micron dental floss, and 50- and 100- micron metal blade

    36 months

Study Arms (2)

Injection molding

EXPERIMENTAL

cavity design, packing technique, bonding technique

Procedure: Injection molding

Incremental packing

ACTIVE COMPARATOR

cavity design, packing technique, bonding technique

Procedure: Incremental packing

Interventions

Injection moldingPROCEDURE

preheated bilk-fill composite, co-cured universal adhesive, David Clark cavity design

Injection molding
Incremental packingPROCEDURE

Incremental packing of conventional composite; pre-cured universal adhesive, non-beveled cavity design

Incremental packing

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Patients with a minimum of one proximal carious lesion in a maxillary or mandibular posterior tooth
  • Selected teeth should have not more than one proximal carious lesion
  • Caries should be extending not more than the outer third of dentin in pre-operative radiograph
  • Presence of antagonist and adjacent teeth for selected molars
  • Vital teeth with no signs or symptoms of pulpitis
  • Anticipated cavity external walls should be in enamel
  • Normal periodontal status and good oral hygiene
  • Mobility grade ≤ 1
  • Good general health

You may not qualify if:

  • Patients with occlusal, buccal or lingual caries lesions in selected teeth
  • Two proximal cavities in selected teeth
  • Extensive carious lesions; shallow enamel lesions or old restorations
  • Absence of antagonist or adjacent teeth
  • Non-vital, hyperemic or endo-treated teeth
  • Cavities requiring gingival margin relocation or pulp capping (direct or indirect)
  • Chronic or acute periodontitis
  • Mobility grade 2 or 3
  • \>50 and \<18 Years old
  • Systemic conditions, allergy to restorative materials and hospitalized patients
  • Evidence of bruxism and temporomandibular joint disorders
  • Patients with low compliance potential

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The British university in Egypt

Cairo, 11111, Egypt

RECRUITING

Related Publications (1)

  • Kitasako Y, Sadr A, Burrow MF, Tagami J. Thirty-six month clinical evaluation of a highly filled flowable composite for direct posterior restorations. Aust Dent J. 2016 Sep;61(3):366-73. doi: 10.1111/adj.12387.

    PMID: 26573239RESULT

MeSH Terms

Conditions

Tissue Adhesions

Condition Hierarchy (Ancestors)

CicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Randa Mohamed

    Professor of Conservative Dentistry

    STUDY CHAIR

Central Study Contacts

Ahmed Zaghloul

CONTACT

+201144633339ag.zaghloul.1@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Assessors and statistician are blinded for the type of restoration placed
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 12, 2021

First Posted

August 25, 2021

Study Start

September 25, 2019

Primary Completion

October 1, 2021

Study Completion

October 1, 2024

Last Updated

August 25, 2021

Record last verified: 2021-08

Locations

EG(1)