NCT04533113

Brief Summary

This study is a prospective randomized controlled study of patients who come to the University. The aim is to evaluate the success rate of selective removal of carious tissue in deep lesions of posterior teeth. Three different materials will be used as liners (VitreBond ™Plus, BioDentine™, and Theracal™ LC). Post-operative pain, clinical, and radiographic success will be evaluated at one, two, and five-year follow-up. The null hypothesis is that there will be no statistically significant differences in rates of successful treatment with the three materials used.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress98%
Feb 2019Jul 2026

Study Start

First participant enrolled

February 20, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 31, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

August 31, 2020

Status Verified

August 1, 2020

Enrollment Period

2.4 years

First QC Date

August 27, 2020

Last Update Submit

August 27, 2020

Conditions

Dental CariesDental Materials

Keywords

Dental cariesDental materialsOutcomePostoperative Pain

Outcome Measures

Primary Outcomes (10)

  • Clinical post-operative pain

    VAS score of patient' level of pain, from no pain to extreme pain

    Immediately post-treatment

  • Clinical post-operative pain

    VAS score of patient' level of pain, from no pain to extreme pain

    8 hours post-treatment

  • Clinical post-operative pain

    VAS score of patient' level of pain, from no pain to extreme pain

    24 hours post-treatment

  • Clinical post-operative pain

    VAS score of patient' level of pain, from no pain to extreme pain

    48 hours post-treatment

  • Clinical signs or symptoms of pulp or periapical disease

    Absence/presence of clinical signs or symptoms of pulp or periapical disease

    1 year

  • Clinical signs or symptoms of pulp or periapical disease

    Absence/presence of clinical signs or symptoms of pulp or periapical disease

    2 years

  • Clinical signs or symptoms of pulp or periapical disease

    Absence/presence of clinical signs or symptoms of pulp or periapical disease

    5 years

  • Radiographic signs of periapical disease

    Absence/presence of radiographic apical periodontitis

    1 year

  • Radiographic signs of periapical disease

    Absence/presence of radiographic apical periodontitis

    2 years

  • Radiographic signs of periapical disease

    Absence/presence of radiographic apical periodontitis

    4 years

Study Arms (3)

VitreBond LC

EXPERIMENTAL

VitreBond LC used as a liner after selective carious tissue removal.

Procedure: Carious tissue selective removal

Biodentine

EXPERIMENTAL

Biodentine used as a liner after selective carious tissue removal.

Procedure: Carious tissue selective removal

Theracal

EXPERIMENTAL

Theracal used as a liner after selective carious tissue removal.

Procedure: Carious tissue selective removal

Interventions

Carious tissue selective removalPROCEDURE

Carious tissue selective removal in deep carious lesions in posterior teeth, using one of three materials as a liner under the final composite restoration

BiodentineTheracalVitreBond LC

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients that demonstrate understanding of the study and willingness to participate as evidenced by signing the voluntary informed consent and received a signed and dated copy of the informed consent form.
  • Understands and is willing to comply with all study procedures and restrictions.
  • Not presence of clinically significant and relevant abnormalities of clinical history or oral examination.
  • Diagnosis of normal pulp or reversible pulpitis.
  • No presence of periapical periodontitis
  • Posterior teeth

You may not qualify if:

  • General: Patients with systemic diseases, diabetes, immunocompromised and pregnant women, or any clinically significant or relevant oral abnormalities.
  • Specific: Impossibility of restoration, diagnosis of irreversible pulpitis or necrosis, preoperative pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

RECRUITING

MeSH Terms

Conditions

Dental CariesPain, Postoperative

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 27, 2020

First Posted

August 31, 2020

Study Start

February 20, 2019

Primary Completion

July 1, 2021

Study Completion (Estimated)

July 1, 2026

Last Updated

August 31, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)