NCT05201664

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 21, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

April 24, 2024

Status Verified

April 1, 2024

Enrollment Period

4.2 years

First QC Date

January 8, 2022

Last Update Submit

April 23, 2024

Conditions

Tooth ExtrudedTooth ExtrusionTooth AvulsionTooth Fracture

Keywords

surgical extrusionoral surgerytooth extrusion

Outcome Measures

Primary Outcomes (3)

  • The position of the soft tissue

    Measurement of the vertical position of the gingival margin before and 6 months after surgery.

    6 months

  • The volume changes in the soft tissue

    Measurement of vestibular alveolar volume before and 6 months after surgery.

    6 months

  • The level of insertion

    Measurement of the periodontal sulcus before and 6 months after surgery.

    6 months

Study Arms (1)

Surgical Extrusion

Patients who receive surgical extrusion treatment in maxillary premolars.

Procedure: Surgical Extrusion

Interventions

Surgical ExtrusionPROCEDURE

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

Surgical Extrusion

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Everyone who attends Clínica Dental Esteve, a private dental clinic in the centre of Alicante.

You may qualify if:

  • Tooth with a subgingival residual dentine margin.
  • Patients refusing tooth extraction and dental implant placement as first choice.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clínica Dental esteve

Alicante, 03001, Spain

RECRUITING

Related Publications (12)

  • 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.

    PMID: 22152612BACKGROUND

  • 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.

    PMID: 24778502BACKGROUND

  • 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.

    PMID: 28808641BACKGROUND

  • 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.

    PMID: 32475015BACKGROUND

  • 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.

    PMID: 27535216BACKGROUND

  • 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.

    PMID: 26522603BACKGROUND

  • 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.

    PMID: 33501680BACKGROUND

  • 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.

    PMID: 32997836BACKGROUND

  • 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.

    PMID: 34574454BACKGROUND

  • 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.

    PMID: 23802693BACKGROUND

  • 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.

    PMID: 30684952BACKGROUND

  • 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.

    PMID: 33179388BACKGROUND

MeSH Terms

Conditions

Tooth AvulsionTooth Fractures

Condition Hierarchy (Ancestors)

Tooth InjuriesTooth DiseasesStomatognathic DiseasesWounds and Injuries

Central Study Contacts

Guillem Esteve-Pardo, DDS

CONTACT

+34 965215755guillem@clinicaesteve.es

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS

Study Record Dates

First Submitted

January 8, 2022

First Posted

January 21, 2022

Study Start

October 1, 2021

Primary Completion

December 1, 2025

Study Completion

April 1, 2026

Last Updated

April 24, 2024

Record last verified: 2024-04

Locations

ES(1)