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

Not Applicable

Completed

• Conditions: Tooth Decay
• Interventions: Procedure: Surgical extrusion

• Registration Number: NCT04350853
• Lead Sponsor: Universitat Internacional de Catalunya

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-20
• Primary Completion: 2019-09-15
• Study Completion: 2020-03-15
• Status Verified: 2020-04
• Study First Submitted: 2020-04-08
• Study First Submitted QC: 2020-04-14
• Last Update Submitted: 2020-04-14
• Study First Posted: 2020-04-17
• Last Update Posted: 2020-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgical extrusion group	Surgical extrusion	Surgical extrusion is performed in each patient of this group

Primary Outcome Measures

Name	Time	Method
Patient's response to pain or discomfort at percussion test	12 months after the surgical extrusion	Patient's response measured by yes/no
Soft tissue rebound	12 months after the surgical extrusion	mm
Tooth mobility (Miller classification)	12 months after the surgical extrusion	mm
Periapical lesion occurrence	12 months after the surgical extrusion	Assessed as the presence or not of a radiolucency at periapical radiograph (yes/no)
Root resorption occurrence	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
Patient's response to pain or discomfort at palpation test	12 months after the surgical extrusion	Patient's response measured by yes/no

Secondary Outcome Measures

Name	Time	Method
Tooth plaque quantity	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).
Interproximal papillae height	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).
Marginal bone loss	12 months after the surgical extrusion	mm
Periodontal probing	12 months after the surgical extrusion	mm
Patient's satisfaction	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).
Gum bleeding on periodontal probing (yes/no)	12 months after the surgical extrusion	Visual
Crown-root ratio	12 months after the surgical extrusion	mm

Trial Locations

Locations (1)

Marc Llaquet Pujol; 🇪🇸 Barcelona, Spain