Clinical trial NCT04350853: Surgical Extrusion for the Clinical Crown Lengthening: a 12-months Clinical Study
Official title: Surgical Extrusion for the Clinical Crown Lengthening: a 12-months Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Decay
Keywords: extrusion
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Soft tissue rebound
timeFrame: 12 months after the surgical extrusion
measure: Tooth mobility (Miller classification)
timeFrame: 12 months after the surgical extrusion
measure: Periapical lesion occurrence
timeFrame: 12 months after the surgical extrusion
measure: Patient's response to pain or discomfort at percussion test
timeFrame: 12 months after the surgical extrusion
measure: Patient's response to pain or discomfort at palpation test
timeFrame: 12 months after the surgical extrusion
measure: Root resorption occurrence
timeFrame: 12 months after the surgical extrusion
Secondary outcomes:
measure: Periodontal probing
timeFrame: 12 months after the surgical extrusion
measure: Gum bleeding on periodontal probing (yes/no)
timeFrame: 12 months after the surgical extrusion
measure: Tooth plaque quantity
timeFrame: 12 months after the surgical extrusion
measure: Interproximal papillae height
timeFrame: 12 months after the surgical extrusion
measure: Marginal bone loss
timeFrame: 12 months after the surgical extrusion
measure: Crown-root ratio
timeFrame: 12 months after the surgical extrusion
measure: Patient's satisfaction
timeFrame: 12 months after the surgical extrusion
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Marc Llaquet Pujol
Study officials:
References:
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.
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.
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.
citation: 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.