NCT04133181

Brief Summary

This study is to compare the clinical and radiographic outcomes after guided periapical endodontic surgery versus conventional endodontic surgery.

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
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration 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

October 17, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 21, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

1.3 years

First QC Date

October 17, 2019

Last Update Submit

October 18, 2019

Conditions

Endodontic DiseaseEndodontic Re-treatment Failure

Keywords

Endodontic surgeryGuided surgery3D guide

Outcome Measures

Primary Outcomes (2)

  • Clinical success

    Clinical assessment using a scale by friedman et al 2005 (healed, healing and persisting disease) which healed mean absence of clinical signs and symptoms, persisting disease mean presence of clinical signs and symptoms

    1 year

  • Radio graphic Success

    Radiograhic assessment using a scale by friedman et al 2005 (healed, healing and persisting disease) which healed mean radiographic classification of complete healing or incomplete healing, persisting disease mean radiographic classification of unsatisfactory healing.

    1 year

Secondary Outcomes (1)

  • Time of surgery

    During surgery

Study Arms (2)

Guided endodontic surgery

EXPERIMENTAL

Use of a 3D surgical guide in endodontic surgery

Device: 3D guide

Conventional endodontic surgery

PLACEBO COMPARATOR

Use of a mock guide in endodontic surgery

Device: Mock guide

Interventions

3D guideDEVICE

Use of a 3D guide in endodontic surgery

Guided endodontic surgery
Mock guideDEVICE

Use of a mock guide in endodontic surgery

Conventional endodontic surgery

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients in good general health.
  • Patients with age ranging between 18-50 years with no sex predilection.
  • Posterior teeth with an indication for endodontic surgery.
  • Patients' acceptance to participate in the study.

You may not qualify if:

  • Patients with allergy to materials or medications used in the trial.
  • Pregnant female patients.
  • Teeth with pathoses associated with vertical root fracture.
  • Severe periodontal bone loss detected with a periodontal probe (5 mm probing depth).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Anderson J, Wealleans J, Ray J. Endodontic applications of 3D printing. Int Endod J. 2018 Sep;51(9):1005-1018. doi: 10.1111/iej.12917. Epub 2018 Mar 23.

    PMID: 29486052BACKGROUND

  • Strbac GD, Schnappauf A, Giannis K, Moritz A, Ulm C. Guided Modern Endodontic Surgery: A Novel Approach for Guided Osteotomy and Root Resection. J Endod. 2017 Mar;43(3):496-501. doi: 10.1016/j.joen.2016.11.001. Epub 2017 Jan 28.

    PMID: 28139285BACKGROUND

  • Ahn SY, Kim NH, Kim S, Karabucak B, Kim E. Computer-aided Design/Computer-aided Manufacturing-guided Endodontic Surgery: Guided Osteotomy and Apex Localization in a Mandibular Molar with a Thick Buccal Bone Plate. J Endod. 2018 Apr;44(4):665-670. doi: 10.1016/j.joen.2017.12.009. Epub 2018 Jan 19.

    PMID: 29358006BACKGROUND

MeSH Terms

Conditions

Dental Pulp Diseases

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Central Study Contacts

Ahmed M Meneisy, Master Degree

CONTACT

+201008143026Ahmed.meneisy@dentistry.cu.edu.eg

Study Design

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

Study Record Dates

First Submitted

October 17, 2019

First Posted

October 21, 2019

Study Start

December 1, 2019

Primary Completion

April 1, 2021

Study Completion

October 1, 2021

Last Updated

October 22, 2019

Record last verified: 2019-10