NCT01733420

Brief Summary

A clinical trial to evaluate and compare three different products used for endodontic treatment (taking the infected nerve out of the teeth) of primary teeth. Null Hypothesis: The new biological products (WMTA and Biodentine) behave as good as the former iodoform product.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2011

Typical duration for phase_3

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 4, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2012

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 27, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

November 22, 2021

Status Verified

November 1, 2021

Enrollment Period

4.1 years

First QC Date

November 7, 2012

Last Update Submit

November 19, 2021

Conditions

Extensive Decay in Primary Molars

Outcome Measures

Primary Outcomes (7)

  • Clinical successes after pulpotomy.

    clinical evaluation and radiography of the tooth is performed. Clinical criteria: abscence of post-operative pain, absence of pain on percussion and palpation, absence of abscess or swelling, absence of sinus tract or fistula and absence of pathologic tooth mobility.

    at baseline visit

  • Clinical success after pulpotomy.

    clinical evaluation and radiography of the tooth is performed. Clinical criteria: abscence of post-operative pain, absence of pain on percussion and palpation, absence of abscess or swelling, absence of sinus tract or fistula and absence of pathologic tooth mobility.

    3 months after pulpotomy.

  • Clinical successes after pulpotomy.

    Clinical evaluation and radiography of the tooth is performed. Clinical criteria: abscence of post-operative pain, absence of pain on percussion and palpation, absence of abscess or swelling, absence of sinus tract or fistula and absence of pathologic tooth mobility.

    6 months after pulpotomy.

  • Clinical successes after pulpotomy.

    Clinical evaluation and radiography of the tooth is performed. Clinical criteria: abscence of post-operative pain, absence of pain on percussion and palpation, absence of abscess or swelling, absence of sinus tract or fistula and absence of pathologic tooth mobility.

    12 months after pulpotomy.

  • Radiographic successes after pulpotomy.

    Radiographic criteria: presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of periradicular radiolucency and no loss or break of lamina dura.

    at baseline visit

  • Radiographic successes after pulpotomy.

    Radiographic criteria: presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of periradicular radiolucency and no loss or break of lamina dura.

    6 months after pulpotomy.

  • Radiographic successes after pulpotomy.

    Radiographic criteria: presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of periradicular radiolucency and no loss or break of lamina dura.

    12 months after pulpotomy.

Study Arms (3)

Biodentine

EXPERIMENTAL

Pulpotomy using Biodentine as pulpotomy medicine.

Drug: Biodentine pulpotomy

White Mineral trioxide Aggregate (MTA)

ACTIVE COMPARATOR

Pulpotomy using white MTA as pulpotomy medicine.

Drug: White MTA pulpotomy

Tempophore

ACTIVE COMPARATOR

Pulpotomy using Tempophore as pulpotomy medicine in a control group.

Drug: Tempophore pulpotomy

Interventions

Biodentine pulpotomyDRUG
Biodentine
White MTA pulpotomyDRUG
White Mineral trioxide Aggregate (MTA)
Tempophore pulpotomyDRUG
Tempophore

Eligibility Criteria

Age2 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Patients (Children with carious deciduous molars indicated for pulpotomy) belonging to the category of ASA I according to the 'American Society of Anaesthesiologists'.
  • Patients without any known medical history of systemic complications contradicting pulp treatment.
  • Patients are indicated for treatment under general anaesthesia due to polycaries / fear / anxiety / very young age.
  • Written consent is obtained from the parent/guardian after explaining the full details of the treatment procedure and its possible outcomes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Study Officials

  • Luc Martens, PhD, DDS

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2012

First Posted

November 27, 2012

Study Start

October 4, 2011

Primary Completion

November 1, 2015

Study Completion

February 1, 2016

Last Updated

November 22, 2021

Record last verified: 2021-11

Locations

BE(1)