Tooth DecayNCT04350853
Surgical Extrusion for the Clinical Crown Lengthening: a 12-months Clinical Study
A study testing Surgical extrusion in people with Tooth Decay, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Decay
- What is being tested?
- Surgical extrusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSpain
- Study dates
- 20 Mar 2018to 15 Mar 2020
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Extrusion for the Clinical Crown Lengthening: a 12-months Prospective Clinical Study
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.
- Conditions
- Tooth Decay
- Being tested
- Surgical extrusion
- Keywords
- extrusion
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical extrusionProcedure or surgery
Surgically coronal reposition of the tooth
| Study group | Role | What they receive |
|---|---|---|
| Surgical extrusion group | Experimental | Surgical extrusion is performed in each patient of this group Receives: Procedure: Surgical extrusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft tissue rebound
mm
Measured: 12 months after the surgical extrusion
Tooth mobility (Miller classification)
mm
Measured: 12 months after the surgical extrusion
Periapical lesion occurrence
Assessed as the presence or not of a radiolucency at periapical radiograph (yes/no)
Measured: 12 months after the surgical extrusion
Patient's response to pain or discomfort at percussion test
Patient's response measured by yes/no
Measured: 12 months after the surgical extrusion
Patient's response to pain or discomfort at palpation test
Patient's response measured by yes/no
Measured: 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
Measured: 12 months after the surgical extrusion
Secondary outcomes (7)
Periodontal probing
mm
Measured: 12 months after the surgical extrusion
Gum bleeding on periodontal probing (yes/no)
Visual
Measured: 12 months after the surgical extrusion
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).
Measured: 12 months after the surgical extrusion
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).
Measured: 12 months after the surgical extrusion
Marginal bone loss
mm
Measured: 12 months after the surgical extrusion
Crown-root ratio
mm
Measured: 12 months after the surgical extrusion
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).
Measured: 12 months after the surgical extrusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start20 Mar 2018
- Primary completion15 Sep 2019
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Tooth DecayStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Llaquet Pujol, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350853
- Sponsor's protocol ID
- 46150711
- Status last verified
- Apr 2020
- First submitted
- 8 Apr 2020
- Last updated
- 17 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Collected data of the present study will be used for future research by the same research team.
Publications
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.
PubMed 9000325Kim 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.
PubMed 14984144Lee 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.
PubMed 25130861Elkhadem 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.
PubMed 23796195
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Extrusion for the Clinical Crown Lengthening: a 12-months Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT04350853
- Acronym / sponsor ID
- 46150711
- Conditions
- Tooth Decay
- Keywords
- extrusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 17 Apr 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical extrusion group | Experimental | Procedure: Surgical extrusionSurgical extrusion is performed in each patient of this group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 extrusionSurgically coronal reposition of the tooth | Procedure or surgery | Surgical extrusion group |
Primary outcome
Soft tissue rebound
Time frame: 12 months after the surgical extrusion
mm
Tooth mobility (Miller classification)
Time frame: 12 months after the surgical extrusion
mm
Periapical lesion occurrence
Time frame: 12 months after the surgical extrusion
Assessed as the presence or not of a radiolucency at periapical radiograph (yes/no)
Patient's response to pain or discomfort at percussion test
Time frame: 12 months after the surgical extrusion
Patient's response measured by yes/no
Patient's response to pain or discomfort at palpation test
Time frame: 12 months after the surgical extrusion
Patient's response measured by yes/no
Root resorption occurrence
Time frame: 12 months after the surgical extrusion
Assessed as the presence or not of an inflammatory root resorption and a replacement root resorption at periapical radiograph
7 secondary outcomes
Periodontal probing
Time frame: 12 months after the surgical extrusion
Gum bleeding on periodontal probing (yes/no)
Time frame: 12 months after the surgical extrusion
Tooth plaque quantity
Time frame: 12 months after the surgical extrusion
Interproximal papillae height
Time frame: 12 months after the surgical extrusion
Marginal bone loss
Time frame: 12 months after the surgical extrusion
Crown-root ratio
Time frame: 12 months after the surgical extrusion
Patient's satisfaction
Time frame: 12 months after the surgical extrusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
- Background: PubMed 9000325Kahnberg 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.
- Background: PubMed 14984144Kim 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.
- Background: PubMed 25130861Lee 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 publication: PubMed 23796195Elkhadem 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.
- Individual participant dataSharing planned: No. Collected data of the present study will be used for future research by the same research team.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical extrusion in people with Tooth Decay, run by Universitat Internacional de Catalunya 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 17 Apr 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Soft tissue rebound (time frame: 12 months after the surgical extrusion). The study lists 6 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 NCT04350853, which also lists 4 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 17 Apr 2020.