Tooth Decay Clinical Trial
Official title:
Surgical Extrusion for the Clinical Crown Lengthening: a 12-months Prospective Clinical Study
NCT number | NCT04350853 |
Other study ID # | 46150711 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 20, 2018 |
Est. completion date | March 15, 2020 |
Verified date | April 2020 |
Source | Universitat Internacional de Catalunya |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Marc Llaquet Pujol | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Universitat Internacional de Catalunya |
Spain,
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
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 |
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