NCT04350853

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 20, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 17, 2020

Completed
Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

1.5 years

First QC Date

April 8, 2020

Last Update Submit

April 14, 2020

Conditions

Tooth Decay

Keywords

extrusion

Outcome Measures

Primary Outcomes (6)

  • Soft tissue rebound

    mm

    12 months after the surgical extrusion

  • Tooth mobility (Miller classification)

    mm

    12 months after the surgical extrusion

  • Periapical lesion occurrence

    Assessed as the presence or not of a radiolucency at periapical radiograph (yes/no)

    12 months after the surgical extrusion

  • Patient's response to pain or discomfort at percussion test

    Patient's response measured by yes/no

    12 months after the surgical extrusion

  • Patient's response to pain or discomfort at palpation test

    Patient's response measured by yes/no

    12 months after the surgical extrusion

  • 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 Outcomes (7)

  • Periodontal probing

    12 months after the surgical extrusion

  • Gum bleeding on periodontal probing (yes/no)

    12 months after the surgical extrusion

  • Tooth plaque quantity

    12 months after the surgical extrusion

  • Interproximal papillae height

    12 months after the surgical extrusion

  • Marginal bone loss

    12 months after the surgical extrusion

  • +2 more secondary outcomes

Study Arms (1)

Surgical extrusion group

EXPERIMENTAL

Surgical extrusion is performed in each patient of this group

Procedure: Surgical extrusion

Interventions

Surgical extrusionPROCEDURE

Surgically coronal reposition of the tooth

Surgical extrusion group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marc Llaquet Pujol

Barcelona, 08021, Spain

Location

Related Publications (4)

  • 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.

    PMID: 9000325BACKGROUND

  • 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.

    PMID: 14984144BACKGROUND

  • 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.

    PMID: 25130861BACKGROUND

  • 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.

    PMID: 23796195RESULT

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 8, 2020

First Posted

April 17, 2020

Study Start

March 20, 2018

Primary Completion

September 15, 2019

Study Completion

March 15, 2020

Last Updated

April 17, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Collected data of the present study will be used for future research by the same research team.

Locations

ES(1)