Root; FractureNCT04430205
Repair of Vertically Fractured Root
An observational study of Root; Fracture, run by Centro di Ricerca Odonotiatrica e Corsi di Aggiornamento Professionale.
Trial summary
Aim and background: The aim of this retrospective observational study is to evaluate the survival rate of cracked teeth, presenting partial (PVF) or complete vertical fracture (CVF), after tooth restoration either with fracture-fragment adhesive bonding or with amalgam restoration. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Root; Fracture
- What is being tested?
- Adhesive restoration protocol
- Type of treatment
- Surgery or procedure
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 1991to 19 Dec 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: One hundred eight fractured teeth, from 99 patients (51 males, 48 females, mean age 50.5 years, standard deviation (SD) 12.8, range 23-84), presenting complete or partial root fracture
Who may be able to join
- Any patient with at least one tooth with a vertical root fracture
Who cannot join
- any patient who does not have at least one tooth with a vertical root fracture
About this study
Official title: Repair of Vertically Fractured Root: An Observational Clinical Study
Aim and background: The aim of this retrospective observational study is to evaluate the survival rate of cracked teeth, presenting partial (PVF) or complete vertical fracture (CVF), after tooth restoration either with fracture-fragment adhesive bonding or with amalgam restoration.
Materials and Methods: One hundred eight fractured teeth, from 99 patients (51 males, 48 females, mean age 50.5 years), presenting complete or partial root fracture, were treated with adhesive restoration or non-adhesive restoration protocol (amalgam) between 1991 and 2019. Demographic and clinical variables were evaluated as predictors of extraction. Furthermore, the bone loss/recovery due to therapy for the fracture was radiographically evaluated at the one year follow-up. All cases were treated by the same operator, using a surgical microscope. Statistical analysis was performed with IBM SPSS Statistics. The study was approved by the ethical committee of Sistema Sanitario Nazionale (prot. N°2370CELazio1).
Read the detailed description
One hundred eight fractured teeth, from 99 patients (51 males, 48 females, mean age 50.5 years, standard deviation (SD) 12.8, range 23-84), presenting complete or partial root fracture, were included in this observational retrospective study. All the teeth were treated according to one of two clinical protocols (adhesive or amalgam, see below). Besides a general medical history and subjective and objective symptoms, the presence of the crack was determined by the usage of a Leica 650 stereomicroscope with the help of methylene blue or eosin-type dyes. The following parameters were gathered from the clinical charts to evaluate possible risk factors for extraction: age, gender, tooth number and type of root fracture (complete or partial). A vitality test was performed with an electrical test, and periodontal probing was performed on six sites per tooth to detect probing defects, using a manual probe. Periapical radiolucency at the moment of the diagnosis, survival in months and type of coronal restoration at the diagnosis (no restoration, single crown, composite, amalgam) were all explored. Presence of calcification in the canal, endo-treatment before the diagnosis of fracture (no treatment, good endodontic treatment, surgical treatment, retreatment), canal obstacles (i.e., broken files) and previous endo-canal retention (no retention, screw post, fibre post, cast post, composite, amalgam) were all determined. Survival was also considered at one, three, five and more than five years, and a qualitative evaluation of the tooth was given (success, functional success: the tooth was asymptomatic; failure: the tooth would be extracted; extracted: the tooth was extracted before the control visit), modifying the European Society of Endodontology for success of endodontic therapies. When evaluating treatment results, a commission made up of three operators, all active members of the Italian Endodontic Society (SIE), re-examined the radiograms and the clinical chart.
The bone loss/recovery due to the therapy of the fracture was radiographically evaluated at the one year follow-up: using Adobe Photoshop, the area of the bone loss was drawn, calculated and compared on radiograms at the moment of the diagnosis and at one year after the treatment, using the same radiological projection and classified as recovered, same loss, or further loss.
Radiographic examination was performed after the restoration, and then the radiographic survey was repeated every six months for the first two years and once a year for the remaining period.
These cases have all been reported, treated and evaluated over time by radiographic and clinical investigation. In all treated cases, the protocol of adhesive restorations was the same, performed and documented with the aid of the Leica 650 surgical microscope by the same operator. The adhesive protocol (87 cases) remained unchanged over time (from 1991 to 2019). A few cases (21 cases) were treated with amalgam, following protocols recommended by the literature to avoid the risk of dental fractures (endo-canal retention and cusp covering).
- Conditions
- Root; Fracture
- Being tested
- Adhesive restoration protocol
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adhesive restoration protocolProcedure or surgery
The canal walls were etched with 37% orthophosphoric acid for 30 seconds with use of a microbrush.
The primer was applied on the wet canal walls, with a microbrush several times, after checking by drying the canal, that the appearance of the dentine was shiny and not opaque or chalky.
The next step was the application of bonding with a microbrush, blowing in the fracture line to make sure it is not loaded with bonding.
Flow composite was used to make it penetrate the fracture line with the help of a 0.06 mm k-file.
The canals were filled with dual composite parts more deeply, light cured at the canal entrance and pulp chamber; the following phase was the coronal restoration with a sandwich technique, covering the cusp with composite.
What is being measured
The primary outcome is the main question the study is designed to answer.
Results
Survival rate of teeth with vertical root fracture will be considered at one, three, five and more than five years, and a qualitative evaluation of the tooth will be given, clinically and radiographically:
- success: tooth is asymptomatic and there is not radiographc lesion;
- functional success: the tooth is asymptomatic but there is a radiographic lesion;
- failure: the tooth would be extracted because of symptoms and/or radiographic lesion getting worse;
- extracted: the tooth was extracted before the control visit.
Measured: from 1991 to 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start15 Jul 1991
- Primary completion5 Sep 2019
- Study completion19 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Root; FractureStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro di Ricerca Odonotiatrica e Corsi di Aggiornamento Professionale
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabrizio Zaccheo, Centro di Ricerca Odonotiatrica e Corsi di Aggiornamento Professionale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430205
- Sponsor's protocol ID
- 2370CELazio1
- Status last verified
- Jun 2020
- First submitted
- 5 Jun 2020
- Last updated
- 12 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Malentacca A, Zaccheo F, Scialanca M, Fordellone F, Rupe C, Lajolo C. Repair of teeth with cracks in crowns and roots: An observational clinical study. Int Endod J. 2021 Oct;54(10):1738-1753. doi: 10.1111/iej.13598. Epub 2021 Aug 16.
PubMed 34291470
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repair of Vertically Fractured Root: An Observational Clinical Study
- ClinicalTrials.gov ID
- NCT04430205
- Acronym / sponsor ID
- 2370CELazio1
- Conditions
- Root; Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Centro di Ricerca Odonotiatrica e Corsi di Aggiornamento ProfessionaleUniversity, hospital or other
- Study start
- 15 Jul 1991 (actual)
- Primary completion
- 5 Sep 2019 (actual)
- Study completion
- 19 Dec 2019 (actual)
- First posted
- 12 Jun 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.
Aim and background: The aim of this retrospective observational study is to evaluate the survival rate of cracked teeth, presenting partial (PVF) or complete vertical fracture (CVF), after tooth restoration either with fracture-fragment adhesive bonding or with amalgam restoration.
Materials and Methods: One hundred eight fractured teeth, from 99 patients (51 males, 48 females, mean age 50.5 years), presenting complete or partial root fracture, were treated with adhesive restoration or non-adhesive restoration protocol (amalgam) between 1991 and 2019. Demographic and clinical variables were evaluated as predictors of extraction. Furthermore, the bone loss/recovery due to therapy for the fracture was radiographically evaluated at the one year follow-up. All cases were treated by the same operator, using a surgical microscope. Statistical analysis was performed with IBM SPSS Statistics. The study was approved by the ethical committee of Sistema Sanitario Nazionale (prot. N°2370CELazio1).
Detailed description
One hundred eight fractured teeth, from 99 patients (51 males, 48 females, mean age 50.5 years, standard deviation (SD) 12.8, range 23-84), presenting complete or partial root fracture, were included in this observational retrospective study. All the teeth were treated according to one of two clinical protocols (adhesive or amalgam, see below). Besides a general medical history and subjective and objective symptoms, the presence of the crack was determined by the usage of a Leica 650 stereomicroscope with the help of methylene blue or eosin-type dyes. The following parameters were gathered from the clinical charts to evaluate possible risk factors for extraction: age, gender, tooth number and type of root fracture (complete or partial). A vitality test was performed with an electrical test, and periodontal probing was performed on six sites per tooth to detect probing defects, using a manual probe. Periapical radiolucency at the moment of the diagnosis, survival in months and type of coronal restoration at the diagnosis (no restoration, single crown, composite, amalgam) were all explored. Presence of calcification in the canal, endo-treatment before the diagnosis of fracture (no treatment, good endodontic treatment, surgical treatment, retreatment), canal obstacles (i.e., broken files) and previous endo-canal retention (no retention, screw post, fibre post, cast post, composite, amalgam) were all determined. Survival was also considered at one, three, five and more than five years, and a qualitative evaluation of the tooth was given (success, functional success: the tooth was asymptomatic; failure: the tooth would be extracted; extracted: the tooth was extracted before the control visit), modifying the European Society of Endodontology for success of endodontic therapies. When evaluating treatment results, a commission made up of three operators, all active members of the Italian Endodontic Society (SIE), re-examined the radiograms and the clinical chart.
The bone loss/recovery due to the therapy of the fracture was radiographically evaluated at the one year follow-up: using Adobe Photoshop, the area of the bone loss was drawn, calculated and compared on radiograms at the moment of the diagnosis and at one year after the treatment, using the same radiological projection and classified as recovered, same loss, or further loss.
Radiographic examination was performed after the restoration, and then the radiographic survey was repeated every six months for the first two years and once a year for the remaining period.
These cases have all been reported, treated and evaluated over time by radiographic and clinical investigation. In all treated cases, the protocol of adhesive restorations was the same, performed and documented with the aid of the Leica 650 surgical microscope by the same operator. The adhesive protocol (87 cases) remained unchanged over time (from 1991 to 2019). A few cases (21 cases) were treated with amalgam, following protocols recommended by the literature to avoid the risk of dental fractures (endo-canal retention and cusp covering).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- One hundred eight fractured teeth, from 99 patients (51 males, 48 females, mean age 50.5 years, standard deviation (SD) 12.8, range 23-84), presenting complete or partial root fracture
Key inclusion criteria (1 listed)
- Any patient with at least one tooth with a vertical root fracture
Key exclusion criteria (1 listed)
- any patient who does not have at least one tooth with a vertical root fracture
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 |
|---|---|---|
| Adhesive restoration protocolThe canal walls were etched with 37% orthophosphoric acid for 30 seconds with use of a microbrush. The primer was applied on the wet canal walls, with a microbrush several times, after checking by drying the canal, that the appearance of the dentine was shiny and not opaque or chalky. The next step was the application of bonding with a microbrush, blowing in the fracture line to make sure it is not loaded with bonding. Flow composite was used to make it penetrate the fracture line with the help of a 0.06 mm k-file. The canals were filled with dual composite parts more deeply, light cured at the canal entrance and pulp chamber; the following phase was the coronal restoration with a sandwich technique, covering the cusp with composite. | Procedure or surgery | – |
Primary outcome
Results
Time frame: from 1991 to 2019
Survival rate of teeth with vertical root fracture will be considered at one, three, five and more than five years, and a qualitative evaluation of the tooth will be given, clinically and radiographically: * success: tooth is asymptomatic and there is not radiographc lesion; * functional success: the tooth is asymptomatic but there is a radiographic lesion; * failure: the tooth would be extracted because of symptoms and/or radiographic lesion getting worse; * extracted: the tooth was extracted before the control visit.
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 12 Jun 2020.
- Derived from this study: PubMed 34291470Malentacca A, Zaccheo F, Scialanca M, Fordellone F, Rupe C, Lajolo C. Repair of teeth with cracks in crowns and roots: An observational clinical study. Int Endod J. 2021 Oct;54(10):1738-1753. doi: 10.1111/iej.13598. Epub 2021 Aug 16.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Root; Fracture, run by Centro di Ricerca Odonotiatrica e Corsi di Aggiornamento Professionale.
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 1 inclusion and 1 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 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results (time frame: from 1991 to 2019). 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 NCT04430205, which also lists 1 linked publication.
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 12 Jun 2020.