Condition category
Oral Health
Date applied
25/07/2017
Date assigned
22/09/2017
Last edited
22/09/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A pulpectomy is a procedure that removes infected or diseased pulp (the inside material in a tooth) in order to save the tooth from being pulled. After the pulp is removed, the area inside the tooth is disinfected and then filled with a material. When doing this in young children with their primary (also known as baby) teeth, it is important to do this as quickly as possible in order to not interfere with the child’s development. The pulpectomy treatment could be done in one or two sessions. In a two session procedure, the filling amterial is put in the tooth later. The aim of this study is to see is the procedure will have good results when done in one session as it does in two sessions.

Who can participate?
Children aged two to six years old who require dental treatment in the upper front teeth.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive the treatment in only one session. Those in the second group receive the treatment over two sessions, as they return 30 days after the initial treatment for it to be finalised. Participants are followed up one, two, three, six and 12 months after their treatment to measure the success rates of their treatments.

What are the possible benefits and risks of participating?
Participants may benefit from having their primary teeth treated which allows them to stay in the mouth longer until they naturally fall out. In addition, participants may benefit from free assistance at the pediatric dentistry clinic, with periodic oral health guidelines, which will contribute to the quality of life of their entire family. There may be some risks such as some discomforts related to endodontic techniques may occur, such as sensitivity at the time of anesthesia, discomfort due to anesthetic sensation, adverse reaction causing crying according to the patient, not knowing the procedures used, relative fatigue as a result of the procedure being complex and of greater duration.

Where is the study run from?
Federal University of Santa Maria (Brazil)

When is the study starting and how long is it expected to run for?
August 2016 to May 2017

Who is funding the study?
Brazilian Federal Agency for the Support and Evaluation of Graduate Education, Coordination for the Improvement of Higher Education Personnel, CAPES (Brazil)

Who is the main contact?
Mrs Lisara Tosatto Pinto
lisaratp@smail.ufsm.br

Trial website

Contact information

Type

Public

Primary contact

Mrs Lisara Tosatto Pinto

ORCID ID

http://orcid.org/0000-0003-0234-5734

Contact details

Federal University of Santa Maria
Floriano Peixoto
1184
Departament of Stomatology
Santa Maria
97500-124
Brazil

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

U1111-1194-1105

Study information

Scientific title

Single-visit versus multiple-visit endodontic treatment of anterior upper primary teeth with calcium hydroxide as intracanal dressing: Randomized clinical trial

Acronym

Study hypothesis

Null hypothesis:
There is no difference between the two groups.

Ethics approval

Ethics Committee of Federal University of Santa Maria, 03/08/2016, ref: CAAE: 57327516.7.000.5346

Study design

Double blind two armed randomised parallel controlled trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

See additional files

Condition

Endodontic treatment of anterior primary teeth.

Intervention

Participants are allocated to one of two groups after opening of brown envelopes, previously organized within a randomised sequence.

The intervention group receive local anesthesia (Lidocaine 2%), absolute isolation, chemical-mechanical preparation of the root canals with Milton's solution, second-series endodontic files, final irrigation with saline solution 0.9%, paste filling (Calcium Hydroxide PA + zinc oxide powder and propylene glycol), gutta percha blade and final restoration with composite resin.

The control group also receive local anesthesia (Lidocaine 2%), absolute isolation, chemical-mechanical preparation of the root canals with Milton's solution, second-series endodontic files, final irrigation with saline solution 0.9% and paste filling (Calcium Hydroxide PA + zinc oxide powder and propylene glycol), but the restoration is temporary with glass ionomer cement. After 30 days, there is a reintervention in the control group with the exchange of the obturator material, and then the final restoration is done with composite resin.

The operator performs blindly during the procedure, since only the group becomes aware of the final moment of use of the sealing paste. The cases have their performances evaluated at 30, 60, 90 days, six months and one year through clinical and radiographic exams.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Radiographic lesions are measured using the periapical radiography at the beginning and the end of the study.

Secondary outcome measures

Fistula is measured using visual scale at the beginning and the end of the study.

Overall trial start date

15/08/2016

Overall trial end date

29/05/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Upper anterior primary teeth
2. Radiographic alteration suggestive of periapical lesion
3. Cavity that allows restorative recovery
4. Without any previous pulp treatment
5. Good systemic health
6. Between 2 and 6 years of age

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. Root resorption with more than 2/3
2. Radiographic rupture of the pericoronary sac of the permanent successor
3. Syndromes
4. Systemic changes

Recruitment start date

07/03/2016

Recruitment end date

06/03/2017

Locations

Countries of recruitment

Brazil

Trial participating centre

Federal University of Santa Maria
Floriano Peixoto 1184 Departament of Stomatology
Santa Maria
97500-124
Brazil

Sponsor information

Organisation

CAPES

Sponsor details

Setor Bancário Norte (SBN)
Quadra 2
Bloco L
Lote 06
Edifício CAPES – CEP: 70.040-031
Brazília
70.040-031
Brazil

Sponsor type

Government

Website

http://www.capes.gov.br/

Funders

Funder type

Government

Funder name

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior

Alternative name(s)

Brazilian Federal Agency for the Support and Evaluation of Graduate Education, Coordination for the Improvement of Higher Education Personnel, CAPES

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Brazil

Results and Publications

Publication and dissemination plan

The plan for publication in a high-impact peer reviewed jornal, is as soon as possible.

IPD sharing statement:
The type of data and participant level are stored. Among them, there are the clinical sheet, the free and informed consent term, the confidentiality term and the institutional authorization term.

Intention to publish date

02/10/2017

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes