Tooth ExtrudedNCT05201664
Surgical Extrusion: Volumetric and Insertion Analysis at 6 Months.
An observational study of Tooth Extruded and Tooth Extrusion, run by Aula Dental Avanzada at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Tooth Extruded, Tooth Extrusion, Tooth Avulsion
- What is being tested?
- Surgical Extrusion
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2021to 1 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
Study population: Everyone who attends Clínica Dental Esteve, a private dental clinic in the centre of Alicante.
Who may be able to join
- Tooth with a subgingival residual dentine margin.
- Patients refusing tooth extraction and dental implant placement as first choice.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Clínica Dental esteve
Alicante, 03001
Guillem Esteve-Pardo, DDS, +34 965215755, guillem@clinicaesteve.es
Guillem Esteve-Pardo, DDS
About this study
Official title: Surgical Extrusion: Volumetric and Insertion Analysis at 6 Months. Series of 10 Cases
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.
Read the 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.
- Conditions
- Tooth Extruded, Tooth Extrusion, Tooth Avulsion, Tooth Fracture
- Being tested
- Surgical Extrusion
- Keywords
- surgical extrusion, oral surgery, tooth extrusion
- Medical subject headings
- Tooth Avulsion, Tooth Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical ExtrusionProcedure or surgery
Relocation of the remaining tooth structure to a more coronal position within the same original socket.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Extrusion | Patients who receive surgical extrusion treatment in maxillary premolars. Receives: Procedure: Surgical Extrusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The position of the soft tissue
Measurement of the vertical position of the gingival margin before and 6 months after surgery.
Measured: 6 months
The volume changes in the soft tissue
Measurement of vestibular alveolar volume before and 6 months after surgery.
Measured: 6 months
The level of insertion
Measurement of the periodontal sulcus before and 6 months after surgery.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start1 Oct 2021
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Tooth ExtrudedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aula Dental Avanzada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillem Esteve-Pardo, Aula Dental Avanzada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201664
- Sponsor's protocol ID
- EXTQX
- Status last verified
- Apr 2024
- First submitted
- 8 Jan 2022
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 22152612Khasnis 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.
PubMed 24778502Dablanca-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.
PubMed 28808641Bourguignon 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.
PubMed 32475015Pilalas 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.
PubMed 27535216Faria 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.
PubMed 26522603Plotino 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.
PubMed 33501680Gonzalez-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.
PubMed 32997836Cordaro 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.
PubMed 34574454Das 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.
PubMed 23802693Wang 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.
PubMed 30684952Mohamed 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.
PubMed 33179388
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Extrusion: Volumetric and Insertion Analysis at 6 Months. Series of 10 Cases
- ClinicalTrials.gov ID
- NCT05201664
- Acronym / sponsor ID
- EXTQX
- Conditions
- Tooth Extruded, Tooth Extrusion, Tooth Avulsion, Tooth Fracture
- Keywords
- surgical extrusion, oral surgery, tooth extrusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Aula Dental AvanzadaUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical Extrusion | – | Procedure: Surgical ExtrusionPatients who receive surgical extrusion treatment in maxillary premolars. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Everyone who attends Clínica Dental Esteve, a private dental clinic in the centre of Alicante.
Key inclusion criteria (2 listed)
- Tooth with a subgingival residual dentine margin.
- Patients refusing tooth extraction and dental implant placement as first choice.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical ExtrusionRelocation of the remaining tooth structure to a more coronal position within the same original socket. | Procedure or surgery | Surgical Extrusion |
Primary outcome
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.
The volume changes in the soft tissue
Time frame: 6 months
Measurement of vestibular alveolar volume before and 6 months after surgery.
The level of insertion
Time frame: 6 months
Measurement of the periodontal sulcus before and 6 months after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Background: PubMed 22152612Juloski 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.
- Background: PubMed 24778502Khasnis 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.
- Background: PubMed 28808641Dablanca-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.
- Background: PubMed 32475015Bourguignon 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.
- Background: PubMed 27535216Pilalas 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.
- Background: PubMed 26522603Faria 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.
- Background: PubMed 33501680Plotino 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.
- Background: PubMed 32997836Gonzalez-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.
- Background: PubMed 34574454Cordaro 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.
- Background: PubMed 23802693Das 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.
- Background: PubMed 30684952Wang 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.
- Background: PubMed 33179388Mohamed 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tooth Extruded and Tooth Extrusion, run by Aula Dental Avanzada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guillem Esteve-Pardo, DDS (+34 965215755, guillem@clinicaesteve.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The position of the soft tissue (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05201664, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.