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NCT Number: NCT04533113

Carious Tissue Selective Removal on Permanent Posterior Teeth.

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.

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Key information

Conditions

Dental Caries Dental Materials Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location status: Recruiting

Location contact

Juan G. Olivieri, DDS, PhD

CONTACT

[email protected]

935042000

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Carious tissue selective removal

Procedure

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

Primary outcomes

  1. Clinical post-operative pain

    Time frame: Immediately post-treatment

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

  2. Clinical post-operative pain

    Time frame: 8 hours post-treatment

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

  3. Clinical post-operative pain

    Time frame: 24 hours post-treatment

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

  4. Clinical post-operative pain

    Time frame: 48 hours post-treatment

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

  5. Clinical signs or symptoms of pulp or periapical disease

    Time frame: 1 year

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

  6. Clinical signs or symptoms of pulp or periapical disease

    Time frame: 2 years

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

  7. Clinical signs or symptoms of pulp or periapical disease

    Time frame: 5 years

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

  8. Radiographic signs of periapical disease

    Time frame: 1 year

    Absence/presence of radiographic apical periodontitis

  9. Radiographic signs of periapical disease

    Time frame: 2 years

    Absence/presence of radiographic apical periodontitis

  10. Radiographic signs of periapical disease

    Time frame: 4 years

    Absence/presence of radiographic apical periodontitis

Sponsors and collaborators

Lead sponsor

Juan Gonzalo Olivieri

Other

Registry information

Official study title

Carious Tissue Selective Removal on Permanent Posterior Teeth. A Randomized Controlled Clinical Study.

Important dates

Study start
2019
Primary completion
2021
Study completion
2026
First posted
Aug 31, 2020
Registry last updated
Aug 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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