NCT03838094

Brief Summary

Aim of the study: To compare the clinical and radiographic outcomes of mineral trioxide aggregate (MTA) and Biodentine as vital pulp therapy materials (pulpotomy) of cariously exposed vital immature mandibular first permanent molars. Materials and Methods: sixty immature first mandibular permanent molars cariously exposed with symptomatic /asymptomatic pulpitis were included in the study according to inclusion criteria and were equally divided in two groups. Following split-mouth design molars were randomly assigned to either a control group (MTA 30 molars) or a test group (Biodentine 30 molars). After conducting pulpotomy and covering pulp stumps with the MTA and Biodentine, treated molars received permanent restorations. Blinded clinical and radiographic evaluations were performed at different time intervals (base line immediate postoperative, 6, 12 and 18 months) according to clinical and radiographic criteria of success. Data were recorded and analysed.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2016

Typical duration for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
Last Updated

February 12, 2019

Status Verified

February 1, 2019

Enrollment Period

2.5 years

First QC Date

February 6, 2019

Last Update Submit

February 8, 2019

Conditions

Carious Exposure of Pulp

Keywords

pulp exposurevital immatureMTABiodentine

Outcome Measures

Primary Outcomes (3)

  • pain, sensitivity to percussion⁄ palpation

    by asking the patient( binary measure)Yes or No, where Yes indicates presence of pain that shows clinical failure

    18 months

  • Swelling or sinus tract

    by visual examination( Binary measure) (Yes or No) where No indicates success of the treatment

    18 months

  • tooth mobility

    by back of the mirror( Binary measure) (Yes or No) where No mobility indicates success of the treatment

    18 months

Secondary Outcomes (4)

  • root formation/development stage

    18 months

  • Crown: Root ratio

    18 months

  • Apical closure

    18 months

  • presence of radiolucency

    18 month

Study Arms (2)

MTA Group

ACTIVE COMPARATOR

pulpotomy technique using fast-setting mineral trioxide aggregate (MTA) to be considered the control group for vital pulp therapy and was placed over the amputated pulps for 18 months. This group will be compared with the Biodentine group as the intervention group

Biological: MTA

Biodentine group

EXPERIMENTAL

3 mm- thick Biodentine covered radicular pulp to allow pulp regeneration

Biological: Biodentine

Interventions

BiodentineBIOLOGICAL

it is a dentin substitute, a new biologically active material facilitates its penetration through opened dentinal tubules to crystallize interlocking with dentin and provide mechanical properties.

Also known as: Calcium silicate-based biomaterial
Biodentine group
MTABIOLOGICAL

MTA is a powder that consists of fine hydrophilic particles that set in the presence of moisture. MTA consists of tricalcium silicate, tricalcium aluminate, tricalcium oxide and silicate oxide. MTA was considered a remarkable biocompatible material with various clinical applications that include surgical and non-surgical applications such as pulp capping

Also known as: mineral trioxide aggregate
MTA Group

Eligibility Criteria

Age7 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Bilaterally Symptomatic ⁄ asymptomatic vital immature mandibular first permanent molars (with clinical carious exposure of the pulp and presence of bleeding upon exposure)
  • Patients with an age range from 7-8 years.
  • Absence of sinus tract, soft tissue swelling.

You may not qualify if:

  • Molars were excluded if non-restorable.
  • excessive mobility (more than 1 mm horizontally).
  • Radiographic evidence of peri- and ⁄or inter-radicular lesions, internal⁄ external root resorption, pulp⁄ canal calcifications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

tricalcium silicatePemetrexedmineral trioxide aggregate

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

Study Officials

  • Gihan M Abuelniel, PhD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Pediatric Dentistry

Study Record Dates

First Submitted

February 6, 2019

First Posted

February 12, 2019

Study Start

February 1, 2016

Primary Completion

August 1, 2018

Study Completion

September 1, 2018

Last Updated

February 12, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

only final results