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

Tooth Decay Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04350853
• Other study ID #: 46150711
• Status: Completed
• Phase: N/A
• Start date: March 20, 2018
• Est. completion date: March 15, 2020

Study information

• Verified date: April 2020
• Source: Universitat Internacional de Catalunya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: March 15, 2020
• Est. primary completion date: September 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• Tooth Decay

Intervention

Procedure:
• Surgical extrusion
Surgically coronal reposition of the tooth

Locations

Country	Name	City	State
Spain	Marc Llaquet Pujol	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Universitat Internacional de Catalunya

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. Revi — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Soft tissue rebound	mm	12 months after the surgical extrusion
Primary	Tooth mobility (Miller classification)	mm	12 months after the surgical extrusion
Primary	Periapical lesion occurrence	Assessed as the presence or not of a radiolucency at periapical radiograph (yes/no)	12 months after the surgical extrusion
Primary	Patient's response to pain or discomfort at percussion test	Patient's response measured by yes/no	12 months after the surgical extrusion
Primary	Patient's response to pain or discomfort at palpation test	Patient's response measured by yes/no	12 months after the surgical extrusion
Primary	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	Periodontal probing	mm	12 months after the surgical extrusion
Secondary	Gum bleeding on periodontal probing (yes/no)	Visual	12 months after the surgical extrusion
Secondary	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
Secondary	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
Secondary	Marginal bone loss	mm	12 months after the surgical extrusion
Secondary	Crown-root ratio	mm	12 months after the surgical extrusion
Secondary	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