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Completed

NCT Number: NCT04350853

Surgical Extrusion for the Clinical Crown Lengthening: a 12-months Clinical Study

This is a prospective study in which surgical extrusion of single-rooted teeth is carried out by the same operator in 15 consecutive patients.

Main objective: to evaluate the soft tissue rebound of the teeth 1 year after the surgery.

Null hypothesis (H0): surgical extrusion is not a predictable treatment for the restoration of single rooted teeth.

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Key information

Conditions

Tooth Decay Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marc Llaquet Pujol

Barcelona, 08021, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Systemically and periodontally healthy, non-smoking patients.
  • Single-rooted, straight teeth with insufficient ferrule, which require restorative treatment.
  • Teeth with a favorable crown-root ratio.

Exclusion criteria

  • Severe systemic disease patients (American Society of Anesthesiologists classification 1 or 2).
  • Multi-rooted, curved and/or short teeth.
  • Teeth with an uncontrolled periodontal pathology.
  • Pregnant women.
  • Teeth with types ll or lll mobility.

Treatment and study plan

Surgical extrusion

Procedure

Surgically coronal reposition of the tooth

Primary outcomes

  1. Soft tissue rebound

    Time frame: 12 months after the surgical extrusion

    mm

  2. Tooth mobility (Miller classification)

    Time frame: 12 months after the surgical extrusion

    mm

  3. Periapical lesion occurrence

    Time frame: 12 months after the surgical extrusion

    Assessed as the presence or not of a radiolucency at periapical radiograph (yes/no)

  4. Patient's response to pain or discomfort at percussion test

    Time frame: 12 months after the surgical extrusion

    Patient's response measured by yes/no

  5. Patient's response to pain or discomfort at palpation test

    Time frame: 12 months after the surgical extrusion

    Patient's response measured by yes/no

  6. Root resorption occurrence

    Time frame: 12 months after the surgical extrusion

    Assessed as the presence or not of an inflammatory root resorption and a replacement root resorption at periapical radiograph

Secondary outcomes

  1. Periodontal probing

    Time frame: 12 months after the surgical extrusion

    mm

  2. Gum bleeding on periodontal probing (yes/no)

    Time frame: 12 months after the surgical extrusion

    Visual

  3. Tooth plaque quantity

    Time frame: 12 months after the surgical extrusion

    Measured visually according to Turesky plaque index, in which the best score is 0 (no plaque) and the worst score is 5 (plaque covering 2/3 or more the crown of the tooth).

  4. Interproximal papillae height

    Time frame: 12 months after the surgical extrusion

    Measured visually according to Jemt's index, in which the best score is 3 (interproximal space completely occupied) and the worst score is 0 (absent interproximal papilla).

  5. Marginal bone loss

    Time frame: 12 months after the surgical extrusion

    mm

  6. Crown-root ratio

    Time frame: 12 months after the surgical extrusion

    mm

  7. Patient's satisfaction

    Time frame: 12 months after the surgical extrusion

    Measured visually using a visual analogue scale, in which the best score is 0 (highest level of patient's satisfaction) and the worst score is 10 (lowest level of patient's satisfaction).

Sponsors and collaborators

Lead sponsor

Universitat Internacional de Catalunya

Other

Registry information

Official study title

Surgical Extrusion for the Clinical Crown Lengthening: a 12-months Prospective Clinical Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Apr 17, 2020
Registry last updated
Apr 17, 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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