NCT04580862

Brief Summary

To compare the incidence of post-operative pain after single-visit versus two-visit non-surgical endodontic retreatment.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

May 5, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 9, 2020

Completed
7 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

October 9, 2020

Status Verified

October 1, 2020

Enrollment Period

7 months

First QC Date

May 5, 2020

Last Update Submit

October 7, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence and intensity of postoperative

    Evaluate incidence and intensity of postoperative pain at 6,12,24, 48hours , and one week using numerical visual scale (NRS) after each visit endodontic retreatment

    At one week after each visit

Secondary Outcomes (1)

  • Number of analgesic tablets

    baseline

Study Arms (2)

group 1 Non-surgical endodontic retreatment in single visit

EXPERIMENTAL

Single visit treatments have gained more popularity. Completing the treatment in a single appointment has many advantages including reduction in treatment time and cost, lower risk of micro leakage and recontamination of root canals between appointments

Other: Non-surgical endodontic retreatment in single visit

group 2 Non-surgical endodontic retreatment in Two-visit

ACTIVE COMPARATOR

Two-visit endodontic treatment with intra-canal medication was traditionally found to be effective in decreasing the number of flare-up in all retreatment cases and in reducing postoperative pain of previously symptomatic teeth

Other: Non-surgical endodontic retreatment in single visit

Interventions

Full medical and dental history using a schematic dental chart, will be obtained from all patients treated during this study.

Also known as: Non-surgical endodontic retreatment in Two-visit
group 1 Non-surgical endodontic retreatment in single visitgroup 2 Non-surgical endodontic retreatment in Two-visit

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Clinically asymptomatic.
  • Previously treated teeth in need of retreatment due to leakage and/or improper filling.
  • No periapical radiolucency.
  • No percussion pains.
  • Age 20 - 45.
  • Premolar teeth.
  • Male \& female.

You may not qualify if:

  • Complicating compromised patient.
  • Tenderness to percussion and acute apical abscess.
  • Presence of an associated sinus tract.
  • Presence of swelling in adjacent soft tissue.
  • Teeth with periodontal pathologies or mobility.
  • Teeth representing root fracture.
  • Pregnant women.
  • If analgesics or antibiotics have been administrated by the patient during the past 24 hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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

MeSH Terms

Conditions

Tooth, Nonvital

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

May 5, 2020

First Posted

October 9, 2020

Study Start

October 1, 2020

Primary Completion

May 1, 2021

Study Completion

June 1, 2021

Last Updated

October 9, 2020

Record last verified: 2020-10