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

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

Study Overview

• Status: Completed
• Conditions: Tooth Decay
• Intervention / Treatment: Procedure: Surgical extrusion

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08021
    • Marc Llaquet Pujol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Surgical extrusion group; Surgical extrusion is performed in each patient of this group	Procedure: Surgical extrusion; Surgically coronal reposition of the tooth

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universitat Internacional de Catalunya

Publications and helpful links

General Publications

• Kahnberg KE. Intra-alveolar transplantation. I. A 10-year follow-up of a method for surgical extrusion of root fractured teeth. Swed Dent J. 1996;20(5):165-72.
• Kim SH, Tramontina V, Passanezi E. A new approach using the surgical extrusion procedure as an alternative for the reestablishment of biologic width. Int J Periodontics Restorative Dent. 2004 Feb;24(1):39-45.
• Lee JH, Yoon SM. Surgical extrusion of multiple teeth with crown-root fractures: a case report with 18-months follow up. Dent Traumatol. 2015 Apr;31(2):150-5. doi: 10.1111/edt.12121. Epub 2014 Aug 11.
• Elkhadem A, Mickan S, Richards D. Adverse events of surgical extrusion in treatment for crown-root and cervical root fractures: a systematic review of case series/reports. Dent Traumatol. 2014 Feb;30(1):1-14. doi: 10.1111/edt.12051. Epub 2013 Jun 25.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 20, 2018
• Primary Completion (ACTUAL): September 15, 2019
• Study Completion (ACTUAL): March 15, 2020

Study Registration Dates

• First Submitted: April 8, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (ACTUAL): April 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 17, 2020
• Last Update Submitted That Met QC Criteria: April 14, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: extrusion
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: 46150711

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Collected data of the present study will be used for future research by the same research team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No