NCT04018456

Brief Summary

The aim of this prospective, randomized, controlled double-blind study is to evaluate the effectiveness of biodentine compared with MTA used as pulp space barrier on discoloration of teeth after regenerative based non-obturation root canal treatment in mature single canal with pulp necrosis and apical periodontitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

July 7, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 12, 2019

Completed
2.1 years until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

July 7, 2019

Last Update Submit

January 21, 2024

Conditions

Necrotic PulpApical Periodontitis

Keywords

Necrotic pulp,Apical periodontitisRegenerationMTABiodentine

Outcome Measures

Primary Outcomes (1)

  • Discoloration of teeth

    Discoloration of teeth that will be assessed clinically through follow up period 3, 6, 9, 12 months by visual examination and by using color shade guide (Tetric N shade guide, Ivoclar Vivadent) whether tooth discolored or not in comparison with the original preoperative color shade.

    Up to one Year after completion of regenerative endodontic treatment

Secondary Outcomes (2)

  • Healing of Periapical Tissue

    after 3, 6,9 and Up to 12 months after completion of regenerative endodontic treatment

  • Restoring the sensibility of tooth

    after 6,9 and Up to 12 months after completion of regenerative endodontic treatment

Study Arms (2)

Biodentine

EXPERIMENTAL

Intervention group: application of biodentine as pulp space barrier during regenerative endodontic treatment.

Other: Biodentine

White MTA

ACTIVE COMPARATOR

Control group: application of White MTA as pulp space barrier during regenerative endodontic treatment.

Other: White MTA

Interventions

BiodentineOTHER

Biodentine is calcium silicate based cement which is bioactive and inductive material. Biodentine will be applied as coronal plug material.

Biodentine
White MTAOTHER

MTA is calcium silicate based cement which is bioactive and inductive material. MTA is used in most cases of regenerative endodontics and it will be applied as coronal plug material.

Also known as: white mineral trioxide aggregate
White MTA

Eligibility Criteria

Age10 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Tooth type: single-rooted teeth (anterior or premolar) encasing of one root canal with mature root (closed apex).
  • Negative response of pulp tissue to electrical or thermal pulp tester.
  • Widening in lamina dura or periapical radiolucency not more than 3 mm.

You may not qualify if:

  • \. Patients having significant systemic disorder or immunocompromised patients. 2. Teeth with generalized chronic periodontitis or have periodontal pocket larger than 3 mm.
  • \. Teeth with developmental anomalies (i.e, dens invaginatusor a palatogingival groove).
  • \. Teeth with previous root canal. 5. Teeth need to post and core as final restoration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dentistry Faculty

Cairo, Egypt

Location

Related Publications (1)

  • Arslan H, Ahmed HMA, Sahin Y, Doganay Yildiz E, Gundogdu EC, Guven Y, Khalilov R. Regenerative Endodontic Procedures in Necrotic Mature Teeth with Periapical Radiolucencies: A Preliminary Randomized Clinical Study. J Endod. 2019 Jul;45(7):863-872. doi: 10.1016/j.joen.2019.04.005. Epub 2019 May 31.

    PMID: 31155298RESULT

MeSH Terms

Conditions

Dental Pulp NecrosisPeriapical Periodontitis

Interventions

tricalcium silicate

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsPeriapical DiseasesJaw DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Study Officials

  • Amatallah HN Al-Rawhani, Master

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants/ outcome assessor will be blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

July 7, 2019

First Posted

July 12, 2019

Study Start

August 1, 2021

Primary Completion

January 1, 2022

Study Completion

June 1, 2023

Last Updated

January 23, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)