Root Canal RetreatmentNCT04746482
Retrospective Assessment of Root Canal Retreatment Performed in Single Visit
An observational study of Root Canal Retreatment, run by Dubai Health Authority at 1 site in United Arab Emirates.
Trial summary
In cases refractory to initial root canal therapy in which a decision is made to perform nonsurgical retreatment, the patient has the right to know the prognosis of the proposed treatment and clinicians must be able to provide this information based on the best available data. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Root Canal Retreatment
- What is being tested?
- single visit root canal retreatment
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 27 Jan 2021to 1 Jun 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who underwent root canal retreatment in single visit in endodontic clinics of Dubai Health Authority (DHA).
Who may be able to join
- Root canal retreatment cases performed in single visits
- Age ranging from 18 - 70 years
- Follow up period of at least 6 months
Who cannot join
- A case will be excluded from the study if the case was under 18 years of age or followed up period for less than 6 months.
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
Dubai Health Authority
Dubai
Hend Abou El Nasr, 00971 521024678, hend.abouelnasr@dentistry.cu.edu.eg
About this study
Official title: Outcome of Root Canal Retreatment Performed in Single Visits. A Retrospective Study
In cases refractory to initial root canal therapy in which a decision is made to perform nonsurgical retreatment, the patient has the right to know the prognosis of the proposed treatment and clinicians must be able to provide this information based on the best available data. The literature answered this question when the treatment was performed in multiple visits; however, little information exists when single visit root canal retreatment was performed. Therefore, the aim of the present study is to assess the clinical and radiographic outcome of root canal retreatment performed in single visits in endodontic clinics of Dubai Health Authority (DHA).
Read the detailed description
The present study is designed to assess the clinical and radiographic outcome of root canal retreatment performed in single visits in endodontic clinics of Dubai Health Authority (DHA). This is a retrospective study where patients' treatment data will be collected and outcome criteria will be applied blindly.
The sample in this retrospective study will be selected from those patients who have undergone single visit endodontic retreatment at the DHA Endodontics clinics from January 2018, through December 2019. The teeth under investigation will be tracked in the database starting from completion of retreatment for at least 6 months, and the percentages of teeth that were retained or underwent additional procedures such as apical surgery or extraction will be recorded.
The clinical and radiographic assessment at baseline and at recall documented in clinical notes, and all data will be collected using a standardized proforma.
The quality of the existing root canal fillings and the status of the periapical tissues will be determined according to the PAI by 2 calibrated independent observers using the periapical radiographs.
- Periapical index (PAI) The index is a radiographic method of interpretation that consists of 5 categories, numbered 1-5.
- Quality of root canal filling
Three criteria were used to assess the quality of the existing root canal fillings as follows:
Length of root canal filling: root filling ending ≤2 mm from the radiographic apex, root filling ending >2 mm from the radiographic apex, or root filling at the radiographic apex (flush).
Density of root canal filling: the presence or absence of voids in the root filling or between the root filling and root canal walls.
Taper of the root canal filling: consistent taper from the orifice to the apex or no consistent taper from the orifice to the apex
The preoperative diagnosis is determined based on clinical and radiographic findings using the American Association of Endodontists Consensus Conference-recommended diagnostic terminology.
Retreatment Procedures
Endodontic retreatment of all cases was conducted in a single visit by endodontic specialists according to the contemporary standards of endodontic therapy.
Only those patients with at least 6 months of clinical and radiographic follow-up were included. When patients returned for recalls, one or multiple (in mutirooted teeth) periapical radiographs were taken.
Follow up
Recall appointments included a radiographic and clinical examination of the treated tooth. The examination was documented and included any signs or symptoms, the presence of a sinus tract, sensitivity to percussion and palpation, swelling, periodontal pockets, or a history of pain.
Periapical radiographs will be evaluated by 2 examiners.
The treatment outcomes will be classified into 3 categories according to the following definitions:
Healed: Functional, asymptomatic teeth with no or minimal radiographic periradicular pathosis (radiolucency) Nonhealed: Nonfunctional, symptomatic teeth with or without radiographic periradicular pathosis or asymptomatic teeth with unchanged, new, or enlarged radiographic periradicular pathosis (radiolucency) Healing: Teeth that are asymptomatic and functional with a decreased size of radiographic periradicular pathosis (radiolucency) .
Collecting data into a recording sheet:
The patients' treatment data will be collected continuously for at least 6 months in the database, and outcome criteria will applied blindly. The teeth will be tracked in the database during the entire period.
- Conditions
- Root Canal Retreatment
- Being tested
- single visit root canal retreatment
- Keywords
- retrospective study, single visit, root canal retreatment, outcome, clinical, radiographic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single visit root canal retreatmentProcedure or surgery
cases that were subject to root canal retreatment performed in single visit
| Study group | Role | What they receive |
|---|---|---|
| exposure group | subjects in this group are single visit Receives: Procedure: single visit root canal retreatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain or swelling
dichotomized into yes or no
Measured: 6 months to 2 years
radiographic
Periapical Index scoring scoring the health of the periapical area using a 5-scale scoring system (from 1 to 5); where1 represents normal periapical tissue while score 5 denotes established apical periodontitis
Measured: 6 months to 2 years
Secondary outcomes (1)
Tooth survival
Number of teeth retained or underwent additional procedures such as apical surgery and extraction
Measured: 6 months to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start27 Jan 2021
- Primary completion1 May 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Root Canal RetreatmentStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dubai Health Authority
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hend Mahmoud Abou El Nasr, Dubai Health Authority
- Investigators
- Hend Abou El Nasr, PhD, Principal investigator, Cairo University and Dubai Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746482
- Sponsor's protocol ID
- DSREC-01/2021_11
- Status last verified
- Feb 2021
- First submitted
- 31 Jan 2021
- Last updated
- 15 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al-Nuaimi N, Ciapryna S, Chia M, Patel S, Mannocci F. A prospective study on the effect of coronal tooth structure loss on the 4-year clinical survival of root canal retreated teeth and retrospective validation of the Dental Practicality Index. Int Endod J. 2020 Aug;53(8):1040-1049. doi: 10.1111/iej.13322. Epub 2020 Jun 8.
PubMed 32383194Habib AA, Doumani MD, Nassani MZ, Shamsy E, Jto BS, ArwadI HA, Mohamed SA. Radiographic Assessment of the Quality of Root Canal Fillings Performed by Senior Dental Students. Eur Endod J. 2018 Jul 19;3(2):101-106. doi: 10.14744/eej.2018.69775. eCollection 2018.
PubMed 32161864Eliyas S, Briggs PFA, Harris IR, Newton JT, Gallagher JE. Development of quality measurement instruments for root canal treatment. Int Endod J. 2017 Jul;50(7):652-666. doi: 10.1111/iej.12679. Epub 2016 Aug 19.
PubMed 27422536Goldberg F, Cantarini C, Alfie D, Macchi RL, Arias A. Relationship between unintentional canal overfilling and the long-term outcome of primary root canal treatments and nonsurgical retreatments: a retrospective radiographic assessment. Int Endod J. 2020 Jan;53(1):19-26. doi: 10.1111/iej.13209. Epub 2019 Sep 30.
PubMed 31454090Ng YL, Mann V, Gulabivala K. Outcome of secondary root canal treatment: a systematic review of the literature. Int Endod J. 2008 Dec;41(12):1026-46. doi: 10.1111/j.1365-2591.2008.01484.x.
PubMed 19133093Gorni FG, Gagliani MM. The outcome of endodontic retreatment: a 2-yr follow-up. J Endod. 2004 Jan;30(1):1-4. doi: 10.1097/00004770-200401000-00001.
PubMed 14760899de Chevigny C, Dao TT, Basrani BR, Marquis V, Farzaneh M, Abitbol S, Friedman S. Treatment outcome in endodontics: the Toronto study--phases 3 and 4: orthograde retreatment. J Endod. 2008 Feb;34(2):131-7. doi: 10.1016/j.joen.2007.11.003. Epub 2007 Dec 21.
PubMed 18215667Erdem Hepsenoglu Y, Eyuboglu TF, Ozcan M. Postoperative Pain Intensity after Single- versus Two-visit Nonsurgical Endodontic Retreatment: A Randomized Clinical Trial. J Endod. 2018 Sep;44(9):1339-1346. doi: 10.1016/j.joen.2018.05.017. Epub 2018 Jul 24.
PubMed 30054099Eyuboglu TF, Olcay K, Ozcan M. A clinical study on single-visit root canal retreatments on consecutive 173 patients: frequency of periapical complications and clinical success rate. Clin Oral Investig. 2017 Jun;21(5):1761-1768. doi: 10.1007/s00784-016-1957-2. Epub 2016 Sep 22.
PubMed 27660159Yoldas O, Topuz A, Isci AS, Oztunc H. Postoperative pain after endodontic retreatment: single- versus two-visit treatment. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2004 Oct;98(4):483-7. doi: 10.1016/j.tripleo.2004.03.009.
PubMed 15472665
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Root Canal Retreatment Performed in Single Visits. A Retrospective Study
- ClinicalTrials.gov ID
- NCT04746482
- Acronym / sponsor ID
- DSREC-01/2021_11
- Conditions
- Root Canal Retreatment
- Keywords
- retrospective study, single visit, root canal retreatment, outcome, clinical, radiographic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dubai Health AuthorityOther government
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 9 Feb 2021 (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.
In cases refractory to initial root canal therapy in which a decision is made to perform nonsurgical retreatment, the patient has the right to know the prognosis of the proposed treatment and clinicians must be able to provide this information based on the best available data. The literature answered this question when the treatment was performed in multiple visits; however, little information exists when single visit root canal retreatment was performed. Therefore, the aim of the present study is to assess the clinical and radiographic outcome of root canal retreatment performed in single visits in endodontic clinics of Dubai Health Authority (DHA).
Detailed description
The present study is designed to assess the clinical and radiographic outcome of root canal retreatment performed in single visits in endodontic clinics of Dubai Health Authority (DHA). This is a retrospective study where patients' treatment data will be collected and outcome criteria will be applied blindly.
The sample in this retrospective study will be selected from those patients who have undergone single visit endodontic retreatment at the DHA Endodontics clinics from January 2018, through December 2019. The teeth under investigation will be tracked in the database starting from completion of retreatment for at least 6 months, and the percentages of teeth that were retained or underwent additional procedures such as apical surgery or extraction will be recorded.
The clinical and radiographic assessment at baseline and at recall documented in clinical notes, and all data will be collected using a standardized proforma.
The quality of the existing root canal fillings and the status of the periapical tissues will be determined according to the PAI by 2 calibrated independent observers using the periapical radiographs.
- Periapical index (PAI) The index is a radiographic method of interpretation that consists of 5 categories, numbered 1-5.
- Quality of root canal filling
Three criteria were used to assess the quality of the existing root canal fillings as follows:
Length of root canal filling: root filling ending ≤2 mm from the radiographic apex, root filling ending >2 mm from the radiographic apex, or root filling at the radiographic apex (flush).
Density of root canal filling: the presence or absence of voids in the root filling or between the root filling and root canal walls.
Taper of the root canal filling: consistent taper from the orifice to the apex or no consistent taper from the orifice to the apex
The preoperative diagnosis is determined based on clinical and radiographic findings using the American Association of Endodontists Consensus Conference-recommended diagnostic terminology.
Retreatment Procedures
Endodontic retreatment of all cases was conducted in a single visit by endodontic specialists according to the contemporary standards of endodontic therapy.
Only those patients with at least 6 months of clinical and radiographic follow-up were included. When patients returned for recalls, one or multiple (in mutirooted teeth) periapical radiographs were taken.
Follow up
Recall appointments included a radiographic and clinical examination of the treated tooth. The examination was documented and included any signs or symptoms, the presence of a sinus tract, sensitivity to percussion and palpation, swelling, periodontal pockets, or a history of pain.
Periapical radiographs will be evaluated by 2 examiners.
The treatment outcomes will be classified into 3 categories according to the following definitions:
Healed: Functional, asymptomatic teeth with no or minimal radiographic periradicular pathosis (radiolucency) Nonhealed: Nonfunctional, symptomatic teeth with or without radiographic periradicular pathosis or asymptomatic teeth with unchanged, new, or enlarged radiographic periradicular pathosis (radiolucency) Healing: Teeth that are asymptomatic and functional with a decreased size of radiographic periradicular pathosis (radiolucency) .
Collecting data into a recording sheet:
The patients' treatment data will be collected continuously for at least 6 months in the database, and outcome criteria will applied blindly. The teeth will be tracked in the database during the entire period.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| exposure group | – | Procedure: single visit root canal retreatmentsubjects in this group are single visit |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who underwent root canal retreatment in single visit in endodontic clinics of Dubai Health Authority (DHA).
Key inclusion criteria (3 listed)
- Root canal retreatment cases performed in single visits
- Age ranging from 18 - 70 years
- Follow up period of at least 6 months
Key exclusion criteria (1 listed)
- A case will be excluded from the study if the case was under 18 years of age or followed up period for less than 6 months.
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 |
|---|---|---|
| single visit root canal retreatmentcases that were subject to root canal retreatment performed in single visit | Procedure or surgery | exposure group |
Primary outcome
Postoperative pain or swelling
Time frame: 6 months to 2 years
dichotomized into yes or no
radiographic
Time frame: 6 months to 2 years
Periapical Index scoring scoring the health of the periapical area using a 5-scale scoring system (from 1 to 5); where1 represents normal periapical tissue while score 5 denotes established apical periodontitis
1 secondary outcome
Tooth survival
Time frame: 6 months to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Background: PubMed 32383194Al-Nuaimi N, Ciapryna S, Chia M, Patel S, Mannocci F. A prospective study on the effect of coronal tooth structure loss on the 4-year clinical survival of root canal retreated teeth and retrospective validation of the Dental Practicality Index. Int Endod J. 2020 Aug;53(8):1040-1049. doi: 10.1111/iej.13322. Epub 2020 Jun 8.
- Background: PubMed 32161864Habib AA, Doumani MD, Nassani MZ, Shamsy E, Jto BS, ArwadI HA, Mohamed SA. Radiographic Assessment of the Quality of Root Canal Fillings Performed by Senior Dental Students. Eur Endod J. 2018 Jul 19;3(2):101-106. doi: 10.14744/eej.2018.69775. eCollection 2018.
- Background: PubMed 27422536Eliyas S, Briggs PFA, Harris IR, Newton JT, Gallagher JE. Development of quality measurement instruments for root canal treatment. Int Endod J. 2017 Jul;50(7):652-666. doi: 10.1111/iej.12679. Epub 2016 Aug 19.
- Background: PubMed 31454090Goldberg F, Cantarini C, Alfie D, Macchi RL, Arias A. Relationship between unintentional canal overfilling and the long-term outcome of primary root canal treatments and nonsurgical retreatments: a retrospective radiographic assessment. Int Endod J. 2020 Jan;53(1):19-26. doi: 10.1111/iej.13209. Epub 2019 Sep 30.
- Background: PubMed 19133093Ng YL, Mann V, Gulabivala K. Outcome of secondary root canal treatment: a systematic review of the literature. Int Endod J. 2008 Dec;41(12):1026-46. doi: 10.1111/j.1365-2591.2008.01484.x.
- Background: PubMed 14760899Gorni FG, Gagliani MM. The outcome of endodontic retreatment: a 2-yr follow-up. J Endod. 2004 Jan;30(1):1-4. doi: 10.1097/00004770-200401000-00001.
- Background: PubMed 18215667de Chevigny C, Dao TT, Basrani BR, Marquis V, Farzaneh M, Abitbol S, Friedman S. Treatment outcome in endodontics: the Toronto study--phases 3 and 4: orthograde retreatment. J Endod. 2008 Feb;34(2):131-7. doi: 10.1016/j.joen.2007.11.003. Epub 2007 Dec 21.
- Background: PubMed 30054099Erdem Hepsenoglu Y, Eyuboglu TF, Ozcan M. Postoperative Pain Intensity after Single- versus Two-visit Nonsurgical Endodontic Retreatment: A Randomized Clinical Trial. J Endod. 2018 Sep;44(9):1339-1346. doi: 10.1016/j.joen.2018.05.017. Epub 2018 Jul 24.
- Background: PubMed 27660159Eyuboglu TF, Olcay K, Ozcan M. A clinical study on single-visit root canal retreatments on consecutive 173 patients: frequency of periapical complications and clinical success rate. Clin Oral Investig. 2017 Jun;21(5):1761-1768. doi: 10.1007/s00784-016-1957-2. Epub 2016 Sep 22.
- Background: PubMed 15472665Yoldas O, Topuz A, Isci AS, Oztunc H. Postoperative pain after endodontic retreatment: single- versus two-visit treatment. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2004 Oct;98(4):483-7. doi: 10.1016/j.tripleo.2004.03.009.
- 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.
Hend Abou El Nasr, PhD principal investigator
Cairo University and Dubai Health Authority
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 Root Canal Retreatment, run by Dubai Health Authority at 1 site in United Arab Emirates.
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 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: status not confirmed, as of the sponsor's last update on 15 Feb 2021. 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 United Arab Emirates. 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 Hend Abou El Nasr (00971 521024678, hend.abouelnasr@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain or swelling (time frame: 6 months to 2 years). The study lists 2 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 NCT04746482, which also lists 10 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 15 Feb 2021.