NCT04746482

Brief 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. 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).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 27, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 31, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

February 15, 2021

Status Verified

February 1, 2021

Enrollment Period

3 months

First QC Date

January 31, 2021

Last Update Submit

February 11, 2021

Conditions

Keywords

retrospective studysingle visitroot canal retreatmentoutcomeclinicalradiographic

Outcome Measures

Primary Outcomes (2)

  • Postoperative pain or swelling

    dichotomized into yes or no

    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

    6 months to 2 years

Secondary Outcomes (1)

  • Tooth survival

    6 months to 2 years

Study Arms (1)

exposure group

subjects in this group are single visit

Procedure: single visit root canal retreatment

Interventions

cases that were subject to root canal retreatment performed in single visit

exposure group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients who underwent root canal retreatment in single visit in endodontic clinics of Dubai Health Authority (DHA).

You may qualify if:

  • Root canal retreatment cases performed in single visits
  • Age ranging from 18 - 70 years
  • Follow up period of at least 6 months

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dubai Health Authority

Dubai, United Arab Emirates

RECRUITING

Related Publications (10)

  • 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.

    PMID: 32383194BACKGROUND
  • Habib 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.

    PMID: 32161864BACKGROUND
  • Eliyas 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.

    PMID: 27422536BACKGROUND
  • Goldberg 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.

    PMID: 31454090BACKGROUND
  • Ng 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.

    PMID: 19133093BACKGROUND
  • Gorni 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.

    PMID: 14760899BACKGROUND
  • de 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.

    PMID: 18215667BACKGROUND
  • Erdem 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.

    PMID: 30054099BACKGROUND
  • Eyuboglu 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.

    PMID: 27660159BACKGROUND
  • Yoldas 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.

    PMID: 15472665BACKGROUND

Study Officials

  • Hend Abou El Nasr, PhD

    Cairo University and Dubai Health Authority

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor/Specialist Senior Registrar

Study Record Dates

First Submitted

January 31, 2021

First Posted

February 9, 2021

Study Start

January 27, 2021

Primary Completion

May 1, 2021

Study Completion

June 1, 2021

Last Updated

February 15, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations