Back to resultsSurgical Extrusion for the Clinical Crown Lengthening: a 12-months Clinical Study
Primary Purpose
Tooth Decay
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Surgical extrusion
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Decay focused on measuring extrusion
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Marc Llaquet Pujol
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Surgical extrusion group
Arm Description
Surgical extrusion is performed in each patient of this group
Outcomes
Primary Outcome Measures
Soft tissue rebound
mm
Tooth mobility (Miller classification)
mm
Periapical lesion occurrence
Assessed as the presence or not of a radiolucency at periapical radiograph (yes/no)
Patient's response to pain or discomfort at percussion test
Patient's response measured by yes/no
Patient's response to pain or discomfort at palpation test
Patient's response measured by yes/no
Root resorption occurrence
Assessed as the presence or not of an inflammatory root resorption and a replacement root resorption at periapical radiograph
Secondary Outcome Measures
Periodontal probing
mm
Gum bleeding on periodontal probing (yes/no)
Visual
Tooth plaque quantity
Measured visually according to Turesky plaque index, in which the best score is 0 (no plaque) and the worst score is 5 (plaque covering 2/3 or more the crown of the tooth).
Interproximal papillae height
Measured visually according to Jemt's index, in which the best score is 3 (interproximal space completely occupied) and the worst score is 0 (absent interproximal papilla).
Marginal bone loss
mm
Crown-root ratio
mm
Patient's satisfaction
Measured visually using a visual analogue scale, in which the best score is 0 (highest level of patient's satisfaction) and the worst score is 10 (lowest level of patient's satisfaction).
Full Information
NCT ID
NCT04350853
First Posted
April 8, 2020
Last Updated
April 14, 2020
Sponsor
Universitat Internacional de Catalunya
1. Study Identification
Unique Protocol Identification Number
NCT04350853
Brief Title
Surgical Extrusion for the Clinical Crown Lengthening: a 12-months Clinical Study
Official Title
Surgical Extrusion for the Clinical Crown Lengthening: a 12-months Prospective Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 20, 2018 (Actual)
Primary Completion Date
September 15, 2019 (Actual)
Study Completion Date
March 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitat Internacional de Catalunya
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Decay
Keywords
extrusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Surgical extrusion group
Arm Type
Experimental
Arm Description
Surgical extrusion is performed in each patient of this group
Intervention Type
Procedure
Intervention Name(s)
Surgical extrusion
Intervention Description
Surgically coronal reposition of the tooth
Primary Outcome Measure Information:
Title
Soft tissue rebound
Description
mm
Time Frame
12 months after the surgical extrusion
Title
Tooth mobility (Miller classification)
Description
mm
Time Frame
12 months after the surgical extrusion
Title
Periapical lesion occurrence
Description
Assessed as the presence or not of a radiolucency at periapical radiograph (yes/no)
Time Frame
12 months after the surgical extrusion
Title
Patient's response to pain or discomfort at percussion test
Description
Patient's response measured by yes/no
Time Frame
12 months after the surgical extrusion
Title
Patient's response to pain or discomfort at palpation test
Description
Patient's response measured by yes/no
Time Frame
12 months after the surgical extrusion
Title
Root resorption occurrence
Description
Assessed as the presence or not of an inflammatory root resorption and a replacement root resorption at periapical radiograph
Time Frame
12 months after the surgical extrusion
Secondary Outcome Measure Information:
Title
Periodontal probing
Description
mm
Time Frame
12 months after the surgical extrusion
Title
Gum bleeding on periodontal probing (yes/no)
Description
Visual
Time Frame
12 months after the surgical extrusion
Title
Tooth plaque quantity
Description
Measured visually according to Turesky plaque index, in which the best score is 0 (no plaque) and the worst score is 5 (plaque covering 2/3 or more the crown of the tooth).
Time Frame
12 months after the surgical extrusion
Title
Interproximal papillae height
Description
Measured visually according to Jemt's index, in which the best score is 3 (interproximal space completely occupied) and the worst score is 0 (absent interproximal papilla).
Time Frame
12 months after the surgical extrusion
Title
Marginal bone loss
Description
mm
Time Frame
12 months after the surgical extrusion
Title
Crown-root ratio
Description
mm
Time Frame
12 months after the surgical extrusion
Title
Patient's satisfaction
Description
Measured visually using a visual analogue scale, in which the best score is 0 (highest level of patient's satisfaction) and the worst score is 10 (lowest level of patient's satisfaction).
Time Frame
12 months after the surgical extrusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Marc Llaquet Pujol
City
Barcelona
ZIP/Postal Code
08021
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Collected data of the present study will be used for future research by the same research team.
Citations:
PubMed Identifier
9000325
Citation
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.
Results Reference
background
PubMed Identifier
14984144
Citation
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.
Results Reference
background
PubMed Identifier
25130861
Citation
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.
Results Reference
background
PubMed Identifier
23796195
Citation
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.
Results Reference
result
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Surgical Extrusion for the Clinical Crown Lengthening: a 12-months Clinical Study
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