Endodontic treatment of anterior primary teeth in different sessions

ISRCTN ISRCTN16209990
DOI https://doi.org/10.1186/ISRCTN16209990
Secondary identifying numbers U1111-1194-1105
Submission date
25/07/2017
Registration date
22/09/2017
Last edited
01/04/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Mrs Lisara Tosatto Pinto
Public

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

ORCiD logoORCID ID 0000-0003-0234-5734

Study information

Study designDouble blind two armed randomised parallel controlled trial
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Other
Study typeTreatment
Participant information sheet ISRCTN16209990_PIS_Portuguese.pdf
Scientific titleSingle-visit versus multiple-visit endodontic treatment of anterior upper primary teeth with calcium hydroxide as intracanal dressing: Randomized clinical trial
Study objectivesNull hypothesis:
There is no difference between the two groups.
Ethics approval(s)Ethics Committee of Federal University of Santa Maria, 03/08/2016, ref: CAAE: 57327516.7.000.5346
Health condition(s) or problem(s) studiedEndodontic treatment of anterior primary teeth.
InterventionParticipants 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 typeProcedure/Surgery
Primary outcome measureRadiographic lesions are measured using the periapical radiography at the beginning and the end of the study.
Secondary outcome measuresFistula is measured using visual scale at the beginning and the end of the study.
Overall study start date15/08/2016
Completion date29/05/2017

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit2 Years
Upper age limit6 Years
SexBoth
Target number of participants120
Key inclusion criteria1. 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
Key exclusion criteria1. Root resorption with more than 2/3
2. Radiographic rupture of the pericoronary sac of the permanent successor
3. Syndromes
4. Systemic changes
Date of first enrolment07/03/2016
Date of final enrolment06/03/2017

Locations

Countries of recruitment

  • Brazil

Study participating centre

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

Sponsor information

CAPES
Government

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

Website http://www.capes.gov.br/
ROR logo "ROR" https://ror.org/00x0ma614

Funders

Funder type

Government

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior
Government organisation / National government
Alternative name(s)
Brazilian Federal Agency for the Support and Evaluation of Graduate Education, Coordination for the Improvement of Higher Education Personnel, CAPES Foundation, Capes - Ministério da Educação, Coordinación de la formación del personal de nivel superior (Brasil), CAPES
Location
Brazil

Results and Publications

Intention to publish date02/10/2017
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryStored in repository
Publication and dissemination planThe plan for publication in a high-impact peer reviewed jornal, is as soon as possible.
IPD sharing planThe 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.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet 01/04/2019 No Yes

Additional files

ISRCTN16209990_PIS_Portuguese.pdf
Uploaded 01/04/2019

Editorial Notes

01/04/2019: The participant information sheet has been uploaded