- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05201664
Surgical Extrusion: Volumetric and Insertion Analysis at 6 Months.
Surgical Extrusion: Volumetric and Insertion Analysis at 6 Months. Series of 10 Cases
Study Overview
Status
Intervention / Treatment
Detailed Description
After informing the patient and obtaining his or her consent to surgical extrusion treatment, a model of the pre-treatment situation will be obtained by intraoral scanning and the attachment levels will be recorded by periodontal probing at 6 points around the tooth.
The dimensional and positional changes of the soft tissue will be analyzed by superimposing both digital impressions in each patient.
In the same way, periodontal attachment levels before and 6 months after treatment will be compared.
The data will be analyzed statistically and conclusions will be drawn regarding the surgical extrusion treatment.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Guillem Esteve-Pardo, DDS
- Phone Number: +34 965215755
- Email: guillem@clinicaesteve.es
Study Locations
-
-
-
Alicante, Spain, 03001
- Recruiting
- Clínica Dental Esteve
-
Contact:
- Guillem Esteve-Pardo, DDS
- Phone Number: +34 965215755
- Email: guillem@clinicaesteve.es
-
Principal Investigator:
- Guillem Esteve-Pardo, DDS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Tooth with a subgingival residual dentine margin.
- Patients refusing tooth extraction and dental implant placement as first choice.
Exclusion Criteria:
- Patients in whom surgical intervention is contraindicated.
- Teeth with vertical fractures up to the apex.
- Teeth with pocket depth >4 mm in any of their walls.
- Failure of the treatment leading to the loss of the extruded tooth.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Surgical Extrusion
Patients who receive surgical extrusion treatment in maxillary premolars.
|
Relocation of the remaining tooth structure to a more coronal position within the same original socket.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The position of the soft tissue
Time Frame: 6 months
|
Measurement of the vertical position of the gingival margin before and 6 months after surgery.
|
6 months
|
|
The volume changes in the soft tissue
Time Frame: 6 months
|
Measurement of vestibular alveolar volume before and 6 months after surgery.
|
6 months
|
|
The level of insertion
Time Frame: 6 months
|
Measurement of the periodontal sulcus before and 6 months after surgery.
|
6 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Bourguignon C, Cohenca N, Lauridsen E, Flores MT, O'Connell AC, Day PF, Tsilingaridis G, Abbott PV, Fouad AF, Hicks L, Andreasen JO, Cehreli ZC, Harlamb S, Kahler B, Oginni A, Semper M, Levin L. International Association of Dental Traumatology guidelines for the management of traumatic dental injuries: 1. Fractures and luxations. Dent Traumatol. 2020 Aug;36(4):314-330. doi: 10.1111/edt.12578. Epub 2020 Jul 17.
- Juloski J, Radovic I, Goracci C, Vulicevic ZR, Ferrari M. Ferrule effect: a literature review. J Endod. 2012 Jan;38(1):11-9. doi: 10.1016/j.joen.2011.09.024. Epub 2011 Nov 13.
- Khasnis SA, Kidiyoor KH, Patil AB, Kenganal SB. Vertical root fractures and their management. J Conserv Dent. 2014 Mar;17(2):103-10. doi: 10.4103/0972-0707.128034.
- Dablanca-Blanco AB, Blanco-Carrion J, Martin-Biedma B, Varela-Patino P, Bello-Castro A, Castelo-Baz P. Management of large class II lesions in molars: how to restore and when to perform surgical crown lengthening? Restor Dent Endod. 2017 Aug;42(3):240-252. doi: 10.5395/rde.2017.42.3.240. Epub 2017 Aug 3.
- Pilalas I, Tsalikis L, Tatakis DN. Pre-restorative crown lengthening surgery outcomes: a systematic review. J Clin Periodontol. 2016 Dec;43(12):1094-1108. doi: 10.1111/jcpe.12617. Epub 2016 Oct 25.
- Faria LP, Almeida MM, Amaral MF, Pellizzer EP, Okamoto R, Mendonca MR. Orthodontic Extrusion as Treatment Option for Crown-Root Fracture: Literature Review with Systematic Criteria. J Contemp Dent Pract. 2015 Sep 1;16(9):758-62. doi: 10.5005/jp-journals-10024-1753.
- Plotino G, Abella Sans F, Duggal MS, Grande NM, Krastl G, Nagendrababu V, Gambarini G. European Society of Endodontology position statement: Surgical extrusion, intentional replantation and tooth autotransplantation: European Society of Endodontology developed by. Int Endod J. 2021 May;54(5):655-659. doi: 10.1111/iej.13456. Epub 2021 Jan 26.
- Gonzalez-Martin O, Carbajo G, Rodrigo M, Montero E, Sanz M. One- versus two-stage crown lengthening surgical procedure for aesthetic restorative purposes: A randomized controlled trial. J Clin Periodontol. 2020 Dec;47(12):1511-1521. doi: 10.1111/jcpe.13375. Epub 2020 Oct 20.
- Cordaro M, Staderini E, Torsello F, Grande NM, Turchi M, Cordaro M. Orthodontic Extrusion vs. Surgical Extrusion to Rehabilitate Severely Damaged Teeth: A Literature Review. Int J Environ Res Public Health. 2021 Sep 10;18(18):9530. doi: 10.3390/ijerph18189530.
- Das B, Muthu MS. Surgical extrusion as a treatment option for crown-root fracture in permanent anterior teeth: a systematic review. Dent Traumatol. 2013 Dec;29(6):423-31. doi: 10.1111/edt.12054. Epub 2013 Jun 26.
- Wang L, Jiang H, Bai Y, Luo Q, Wu H, Liu H. Clinical outcomes after intentional replantation of permanent teeth: A systematic review. Bosn J Basic Med Sci. 2020 Feb 5;20(1):13-20. doi: 10.17305/bjbms.2019.3937.
- Mohamed M, Moheb D, Waly N, Abdalsamad A, Elkhadem A. Effects of different splinting times on surgically extruded teeth with a crown-root fracture: A randomized controlled trial. Dent Traumatol. 2021 Apr;37(2):264-274. doi: 10.1111/edt.12624. Epub 2020 Dec 4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EXTQX
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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