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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05201664
Other study ID # EXTQX
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2021
Est. completion date February 1, 2024

Study information

Verified date January 2023
Source Aula Dental Avanzada
Contact Guillem Esteve-Pardo, DDS
Phone +34 965215755
Email guillem@clinicaesteve.es
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim is to clinically evaluate the changes that occur in teeth that have undergone surgical extrusion treatment. Three parameters will be recorded before and 6 months after treatment: the position and the volume of the soft tissue, and the level of periodontal attachment.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date February 1, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Intervention

Procedure:
Surgical Extrusion
Relocation of the remaining tooth structure to a more coronal position within the same original socket.

Locations

Country Name City State
Spain Clínica Dental esteve Alicante

Sponsors (1)

Lead Sponsor Collaborator
Aula Dental Avanzada

Country where clinical trial is conducted

Spain, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary The position of the soft tissue Measurement of the vertical position of the gingival margin before and 6 months after surgery. 6 months
Primary The volume changes in the soft tissue Measurement of vestibular alveolar volume before and 6 months after surgery. 6 months
Primary The level of insertion Measurement of the periodontal sulcus before and 6 months after surgery. 6 months
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