Condition category
Oral Health
Date applied
05/02/2017
Date assigned
21/06/2017
Last edited
20/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Milk teeth (also known as primary or baby teeth) are temporary teeth in children which fall out before permanent teeth emerge. They are more fragile than permanent ones because they have a thinner layer of enamel recovering them. When milk teeth get a cavity, this can cause the tooth to decay quickly, which worries the parents because the child fails to exercise normally, reports pain and difficulty feeding, even needing to leave the school to solve this situation. The large, open cavities over a long period have a close proximity to the tissues of the tooth nerve, making the child to feel pain. With this, it is often necessary to treat this nerve of the tooth by a technique called pulpotomy to try to save the tooth, so that the child can chew. In addition, the milk tooth will serve as a guide for the permanent tooth to erupt. Calcium hydroxide can be helpful when placed in the wound as paste to improve healing. The aim of this study is to see if a calcium hydroxide (CH) mixtures placed in the tooth area can improve the healing of the tooth.

Who can participate?
Children aged five to eight who have their primary molars

What does the study involve?
Participants are randomly allocated to one of three groups. Those in the first group receive the standard pulpotomy but have their a paste mixed with a gray mineral trioxide aggregate in the wound. Those in the second group receive a paste containing calcium hydroxide mixed with saline (salt water) placed in the wound. Those in the last group receive a paste mixed by calcium hydroxide with polyethylene glycol. Participants are followed up three, six and 12 months after the procedure to see measure the success of the procedures.

What are the possible benefits and risks of participating?
Participants may benefit from having dental treatment and long term follow up. There are risks with the procedure failing and requiring a pulpectomy (a more invasive technique).

Where is the study run from?
Federal University of Alfenas School of Dentistry (Brazil)

When is the study starting and how long is it expected to run for?
January 2013 to July 2015

Who is funding the study?
Federal University of Alfenas (Brazil)

Who is the main contact?
Professor Ana Beatriz Silveira Moretti
ana.moretti@unifal-mg.edu.br

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ana Beatriz Silveira Moretti

ORCID ID

Contact details

Federal University of Alfenas
Rua Gabriel Monteiro da Silva 714
Alfenas
37130-000
Brazil
+55 35 3701 9410
ana.moretti@unifal-mg.edu.br

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Evaluation of pulpotomies in primary teeth with mineral trioxide aggregate and calcium hydroxide associated with different vehicles: Clinical and radiographic outcomes

Acronym

Study hypothesis

When calcium hydroxide (CH) is mixed with a viscous vehicle, it dissociates more slowly thus minimizing the dispersion of CH into the tissues and maintaining the paste in the desired area for longer periods. The CH mixed with aqueous promotes high solubility when in direct contact with tissues and fluids being quickly resorption by macrophages revealing an increase in failure rates over the follow-ups.

Null hypothesis:
There will be no difference in between treatment groups (CH mixed with vehicle aqueous X CH mixed with a viscous vehicle) compared to the MTA.

Ethics approval

Ethics Committee of School of Dentistry, Federal University of Alfenas, 03/06/2013. ref: 15304613.1.0000.5142

Study design

Prospective single-center randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Ideal capping agent for pulpotomy in primary teeth

Intervention

Participants are randomly allocated to one of three groups through a computer generated randomization list.

Group 1 (Control): After local anesthesia and rubber dam isolation, carries are removed (dental decay/cavities) with a hand piece with a round bur. The pulp chambers are opened with a round carbide bur. Full coronal pulp tissues are manually removed with a excavator and are irrigated with a saline solution in order to clear the debris. The wound is continuously irrigated with a saline solution until bleeding ceases. In this group, a paste made containing gray mineral trioxide aggregate (MTA) (Ângelus, Londrina, PR, Brazil) powder with a sterile saline at a ratio of 1:1 is placed in the pulp chamber.

Group 2 (Calcium hydroxide and saline): After local anesthesia and rubber dam isolation, carries are removed (dental decay/cavities) with a hand piece with a round bur. The pulp chambers are opened with a round carbide bur. Full coronal pulp tissues are manually removed with an excavator and are irrigated with a saline solution in order to clear the debris. The wound is continuously irrigated with a saline solution until bleeding ceases. In this group, a paste is made containing of calcium hydroxide P.A. calcium hydroxide P.A. (Biodinâmica Química e Farmacêutica Ltda., Ibiporã, PR, Brazil) with sterile saline at 1:1 powder/saline ratio and is placed in the pulp chamber.

Group 3 (Calcium hydroxide and polyethylene glycol (PEG)): After local anesthesia and rubber dam isolation, carries are removed (dental decay/cavities) with a hand piece with a round bur. The pulp chambers are opened with a round carbide bur. Full coronal pulp tissues are manually removed with an excavator and are irrigated with a saline solution in order to clear the debris. The wound is continuously irrigated with a saline solution until bleeding ceases. In this group, the pulp tissue was dressed with a paste obtained by mixing calcium hydroxide P.A. with PEG at 1:1 powder/solution ratio.

In all groups, a layer of cement-cured calcium hydroxide (Biodinâmica Química e Farmacêutica Ltda., Ibiporã, PR, Brazil) was placed prior to restoration with glass–ionomer cement (Vitremer; 3M ESPE, São Paulo, SP, Brazil). This study takes 24 months, with each intervention taking 12 months and the follow-up takes 12 months.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Clinical success and failures are measured using clinical evaluations at three, six and 12 months
2. Radiographic successes are measured using x-rays at three, six and 12 months

Secondary outcome measures

There are no secondary outcome measures.

Overall trial start date

10/01/2013

Overall trial end date

02/07/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Mandibular primary first or second molar of children between the ages of 5 and 8 years old
2. No more than two mandibular primary molar teeth with vital pulp and no history of pain
3. Clinical macroscopic appearance of the dental pulp (adequate consistency, bright red-colored pulp and cut resistance) thus requiring a pulpotomy therapy
4. No clinical or radiographic evidence of pulp degeneration, such as excessive bleeding, internal root resorption, inter-radicular and/or furcal bone destruction
5. No physiological root resorption of more than one-third, as observed in periapical radiographies
6. The possibility of proper restoration of the teeth

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Forty-five primary molars in children with mean age of 6 years and 5 months were allocated to the three treatment groups (15 teeth per group).

Participant exclusion criteria

1. Excessive pulp bleeding 5 minutes after removal
2. Dark red colored pulp
3. Little cut resistance
4. Presence of systemic pathology
5. Any history of allergic reaction to latex, local anaesthetics or the components of the test pulp dressing agents
6. Teeth with more than 2/3 of radicular resorption

Recruitment start date

20/07/2013

Recruitment end date

01/09/2013

Locations

Countries of recruitment

Brazil

Trial participating centre

Federal University of Alfenas School of Dentistry
Minas Gerais Rua Gabriel Monteiro da Silva 700
Alfenas - Minas Gerais
37.130-000
Brazil

Sponsor information

Organisation

Federal University of Alfenas

Sponsor details

Rua Gabriel Monteiro da Silva 714
Alfenas
37130-000
Brazil

Sponsor type

University/education

Website

www.unifal-mg.edu.br

Funders

Funder type

University/education

Funder name

Federal University of Alfenas

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from ana.moretti@unifal-mg.edu.br

Intention to publish date

10/03/2017

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes