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 measure
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 (if study stopped)
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
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
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
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN16209990_PIS_Portuguese.pdf Uploaded 01/04/2019