Endodontic Treatment of Primary TeethNCT03453658
Mechanized Instrumentation for Endodontic Treatment of Primary Teeth
A study testing Manual instrumentation and Reciprocating Instrumentation in people with Endodontic Treatment of Primary Teeth, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Mechanized instrumentation systems stand out amongst various devices used in modern Endodontics. Its use in Pediatric Dentistry, its action in primary teeth, has been in the center of many discussions and laboratory studies. Nevertheless, up to now, a lack of clinical studies on this issue can be found. Read more about this study
- Who is it for?
- Ages 3 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontic Treatment of Primary Teeth
- What is being tested?
- Manual instrumentation and Reciprocating Instrumentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Nov 2017to 28 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Primary molar teeth with necessity of endodontic treatment.
- Patients whose parents or guardians consent to their participation in the study
Who cannot join
- Teeth presenting one of the following:
- Resorption of more than 2/3 of the root
- Destruction of the crypt of the permanent successor
- Pulp chamber floor drilling.
- Presence of internal resorption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Mechanized Instrumentation for Endodontic Treatment of Primary Teeth - Randomized Clinical Trial
Mechanized instrumentation systems stand out amongst various devices used in modern Endodontics. Its use in Pediatric Dentistry, its action in primary teeth, has been in the center of many discussions and laboratory studies. Nevertheless, up to now, a lack of clinical studies on this issue can be found. Our objective is to conduct a double blinded, 2 years follow up clinical trial to compare the success of endodontic treatment in primary teeth using mechanized reciprocating instrumentation to the use of manual instrumentation.
Read the detailed description
With the approval of the Ethics Committee of University of São Paulo, after clinical and radiographic examination, patients in search for endodontic treatment in primary teeth will be invited to take part in the study. The participants of the study will be randomized to one of two groups (manual or reciprocating instrumentation). Endodontic treatment will be held by a specialist according to the randomized group. A blinded examiner will proceed one week, 3 months, 6 months, 12 months and 24 months follow ups. Clinical and radiographic conditions of endodontic treatments will be analyzed to classify them as Success or Failure. The unit of analysis will be the teeth; hence, each participant may have more than one tooth included in the study. The randomization will be performed considering the tooth. Data analysis will consider the cluster nature of the sample.
The primary outcome of the study will be the success rates according to the groups. The longevity of treatments will be evaluated by estimating survival rates by Kaplan-Meier and Cox regression. The differences between survival rates of both groups will be through Cox regression adjusted for the cluster nature of the sample (more than one tooth per participant), considering a level of significance of 5%.
- Conditions
- Endodontic Treatment of Primary Teeth
- Being tested
- Manual instrumentation, Reciprocating Instrumentation
- Keywords
- Endodontics, Primary Teeth, Reciprocating instrumentation, Mechanized instrumentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual instrumentationProcedure or surgery
Manual conventional files will be used in endodontic treatment of primary teeth
Reciprocating InstrumentationProcedure or surgery
Reciprocating files system will be used in endodontic treatment of primary teeth.
| Study group | Role | What they receive |
|---|---|---|
| Manual instrumentation | Active comparator | Manual instrumentation: Endodontic treatment will be performed with the use of conventional endodontic manual files. Receives: Procedure: Manual instrumentation |
| Reciprocating instrumentation | Experimental | Mechanized instrumentation: Endodontic treatment will be performed with the use of reciprocating mechanized files. The files are activated by an engine that produces reciprocating movements. Receives: Procedure: Reciprocating Instrumentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success or failure of endodontic treatment
The success or failure of endodontic treatments evaluated by the time spent in the tooth arch in clinical conditions of normality. Clinical criteria for determining success are: absence of fistula, absence of painful symptoms and pathological absence of adequate mobility and gingival contour. Radiographically, the success criteria are: absence / reduction of periapical bone rarefaction in anterior and absence / bone rarefaction in the furcation area of later, maintaining the periradicular space, root resorption compatible with the eruptive phase and absence of pathological bone resorption. To evaluate the reduction of lesions or appearance of new lesions will be between the initial and follow-up radiographs. Radiographs will be scanned and the end of the bone rarefactions starting area and will be measured on a software image analysis.
Measured: Two years
Secondary outcomes (4)
Appointment duration
The time spent using both techniques will be measured and compared between the groups. The time will be recorded in minutes since the end of anesthesia and rubber-dam placement until the beginning of restorative procedure.
Measured: After treatment
Quality of obturation provided by two different instrumentation techniques
After root canal obturation, a final periapical radiograph will be digitalized and analyzed, obtaining the percentage of root canal filling provided by each instrumentation technique.
Measured: After treatment
Discomfort related to each instrumentation technique
Discomfort provided by each technique will be analyzed and compared between the groups using a validated facial scale, named Wong-Baker facial scale. This is a scale of 6 drawn faces ranging from a smiling representing no hurt face to as crying hurts worst face. Therefore, the scale has been used to evaluate pain and/or discomfort after several procedures, including dental procedures. The answers can be measured as a qualitative ordinal variable varying from 0 (no hurt) to 5 (Hurts worst). This scale has been used previously in pediatric dentistry context (Tomlinson et al., 2010).
Measured: After treatment.
Cost-Efficacy of each instrumentation technique
The cost-efficacy of each procedure will be analyzed according to the success rate of each technique, and the results obtained will be compared.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start8 Nov 2017
- Primary completion31 Aug 2018
- Study completion28 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Endodontic Treatment of Primary TeethStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, single-blind, controlled clinical trial with two parallel arms.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fausto Medeiros Mendes, University of Sao Paulo
- Investigators
- Renata Marques, PhD Student, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453658
- Sponsor's protocol ID
- FOUSP2912
- Status last verified
- Mar 2021
- First submitted
- 27 Feb 2018
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are planning to share the individual data upon request, since the participants and their legal guardians consent.
Publications
Ahmad IA, Pani SC. Accuracy of electronic apex locators in primary teeth: a meta-analysis. Int Endod J. 2015 Mar;48(3):298-307. doi: 10.1111/iej.12315. Epub 2014 Jun 28.
PubMed 24863852Ahmed HM. Anatomical challenges, electronic working length determination and current developments in root canal preparation of primary molar teeth. Int Endod J. 2013 Nov;46(11):1011-22. doi: 10.1111/iej.12134. Epub 2013 May 25.
PubMed 23711096Canoglu H, Tekcicek MU, Cehreli ZC. Comparison of conventional, rotary, and ultrasonic preparation, different final irrigation regimens, and 2 sealers in primary molar root canal therapy. Pediatr Dent. 2006 Nov-Dec;28(6):518-23.
PubMed 17249433Fumes AC, Sousa-Neto MD, Leoni GB, Versiani MA, da Silva LA, da Silva RA, Consolaro A. Root canal morphology of primary molars: a micro-computed tomography study. Eur Arch Paediatr Dent. 2014 Oct;15(5):317-26. doi: 10.1007/s40368-014-0117-0. Epub 2014 Feb 22.
PubMed 24563173Kummer TR, Calvo MC, Cordeiro MM, de Sousa Vieira R, de Carvalho Rocha MJ. Ex vivo study of manual and rotary instrumentation techniques in human primary teeth. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2008 Apr;105(4):e84-92. doi: 10.1016/j.tripleo.2007.12.008.
PubMed 18329573Fuks AB. Pulp therapy for the primary and young permanent dentitions. Dent Clin North Am. 2000 Jul;44(3):571-96, vii.
PubMed 10925773Lee GH, McGrath C, Yiu CK. Developing clinical practice guidelines for caries prevention and management for pre-school children through the ADAPTE process and Delphi consensus. Health Res Policy Syst. 2016 Jun 14;14(1):44. doi: 10.1186/s12961-016-0117-0.
PubMed 27301382Moura-Netto C, Palo RM, Pinto LF, Mello-Moura AC, Daltoe G, Wilhelmsen NS. CT study of the performance of reciprocating and oscillatory motions in flattened root canal areas. Braz Oral Res. 2015;29:1-6. doi: 10.1590/1807-3107bor-2015.vol29.0006. Epub 2014 Dec 2.
PubMed 25466329Nagaratna PJ, Shashikiran ND, Subbareddy VV. In vitro comparison of NiTi rotary instruments and stainless steel hand instruments in root canal preparations of primary and permanent molar. J Indian Soc Pedod Prev Dent. 2006 Dec;24(4):186-91. doi: 10.4103/0970-4388.28075.
PubMed 17183182Neena IE, Ananthraj A, Praveen P, Karthik V, Rani P. Comparison of digital radiography and apex locator with the conventional method in root length determination of primary teeth. J Indian Soc Pedod Prev Dent. 2011 Oct-Dec;29(4):300-4. doi: 10.4103/0970-4388.86371.
PubMed 22016313Nobrega DF, Fernandez CE, Del Bel Cury AA, Tenuta LM, Cury JA. Frequency of Fluoride Dentifrice Use and Caries Lesions Inhibition and Repair. Caries Res. 2016;50(2):133-40. doi: 10.1159/000444223. Epub 2016 Mar 19.
PubMed 26992247Pinheiro SL, Araujo G, Bincelli I, Cunha R, Bueno C. Evaluation of cleaning capacity and instrumentation time of manual, hybrid and rotary instrumentation techniques in primary molars. Int Endod J. 2012 Apr;45(4):379-85. doi: 10.1111/j.1365-2591.2011.01987.x. Epub 2011 Dec 22.
PubMed 22188162Piovesan C, Mendes FM, Ferreira FV, Guedes RS, Ardenghi TM. Socioeconomic inequalities in the distribution of dental caries in Brazilian preschool children. J Public Health Dent. 2010 Fall;70(4):319-26. doi: 10.1111/j.1752-7325.2010.00191.x.
PubMed 20735719Prabhakar AR, Yavagal C, Dixit K, Naik SV. Reciprocating vs Rotary Instrumentation in Pediatric Endodontics: Cone Beam Computed Tomographic Analysis of Deciduous Root Canals using Two Single-file Systems. Int J Clin Pediatr Dent. 2016 Jan-Mar;9(1):45-9. doi: 10.5005/jp-journals-10005-1332. Epub 2016 Apr 22.
PubMed 27274155Rasquin LC, de Carvalho FB, Lima RK. In vitro evaluation of root canal preparation using oscillatory and rotary systems in flattened root canals. J Appl Oral Sci. 2007 Feb;15(1):65-9. doi: 10.1590/s1678-77572007000100014.
PubMed 19089103
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mechanized Instrumentation for Endodontic Treatment of Primary Teeth - Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03453658
- Acronym / sponsor ID
- FOUSP2912
- Conditions
- Endodontic Treatment of Primary Teeth
- Keywords
- Endodontics, Primary Teeth, Reciprocating instrumentation, Mechanized instrumentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 28 Jan 2021 (actual)
- First posted
- 5 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mechanized instrumentation systems stand out amongst various devices used in modern Endodontics. Its use in Pediatric Dentistry, its action in primary teeth, has been in the center of many discussions and laboratory studies. Nevertheless, up to now, a lack of clinical studies on this issue can be found. Our objective is to conduct a double blinded, 2 years follow up clinical trial to compare the success of endodontic treatment in primary teeth using mechanized reciprocating instrumentation to the use of manual instrumentation.
Detailed description
With the approval of the Ethics Committee of University of São Paulo, after clinical and radiographic examination, patients in search for endodontic treatment in primary teeth will be invited to take part in the study. The participants of the study will be randomized to one of two groups (manual or reciprocating instrumentation). Endodontic treatment will be held by a specialist according to the randomized group. A blinded examiner will proceed one week, 3 months, 6 months, 12 months and 24 months follow ups. Clinical and radiographic conditions of endodontic treatments will be analyzed to classify them as Success or Failure. The unit of analysis will be the teeth; hence, each participant may have more than one tooth included in the study. The randomization will be performed considering the tooth. Data analysis will consider the cluster nature of the sample.
The primary outcome of the study will be the success rates according to the groups. The longevity of treatments will be evaluated by estimating survival rates by Kaplan-Meier and Cox regression. The differences between survival rates of both groups will be through Cox regression adjusted for the cluster nature of the sample (more than one tooth per participant), considering a level of significance of 5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, single-blind, controlled clinical trial with two parallel arms.
| Arm | Type | Receives |
|---|---|---|
| Manual instrumentation | Active comparator | Procedure: Manual instrumentationManual instrumentation: Endodontic treatment will be performed with the use of conventional endodontic manual files. |
| Reciprocating instrumentation | Experimental | Procedure: Reciprocating InstrumentationMechanized instrumentation: Endodontic treatment will be performed with the use of reciprocating mechanized files. The files are activated by an engine that produces reciprocating movements. |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Primary molar teeth with necessity of endodontic treatment.
- Patients whose parents or guardians consent to their participation in the study
Key exclusion criteria (5 listed)
- Resorption of more than 2/3 of the root
- Destruction of the crypt of the permanent successor
- Pulp chamber floor drilling.
- Presence of internal resorption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual instrumentationManual conventional files will be used in endodontic treatment of primary teeth | Procedure or surgery | Manual instrumentation |
| Reciprocating InstrumentationReciprocating files system will be used in endodontic treatment of primary teeth. | Procedure or surgery | Reciprocating instrumentation |
Primary outcome
Success or failure of endodontic treatment
Time frame: Two years
The success or failure of endodontic treatments evaluated by the time spent in the tooth arch in clinical conditions of normality. Clinical criteria for determining success are: absence of fistula, absence of painful symptoms and pathological absence of adequate mobility and gingival contour. Radiographically, the success criteria are: absence / reduction of periapical bone rarefaction in anterior and absence / bone rarefaction in the furcation area of later, maintaining the periradicular space, root resorption compatible with the eruptive phase and absence of pathological bone resorption. To evaluate the reduction of lesions or appearance of new lesions will be between the initial and follow-up radiographs. Radiographs will be scanned and the end of the bone rarefactions starting area and will be measured on a software image analysis.
4 secondary outcomes
Appointment duration
Time frame: After treatment
Quality of obturation provided by two different instrumentation techniques
Time frame: After treatment
Discomfort related to each instrumentation technique
Time frame: After treatment.
Cost-Efficacy of each instrumentation technique
Time frame: Two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Background: PubMed 24863852Ahmad IA, Pani SC. Accuracy of electronic apex locators in primary teeth: a meta-analysis. Int Endod J. 2015 Mar;48(3):298-307. doi: 10.1111/iej.12315. Epub 2014 Jun 28.
- Background: PubMed 23711096Ahmed HM. Anatomical challenges, electronic working length determination and current developments in root canal preparation of primary molar teeth. Int Endod J. 2013 Nov;46(11):1011-22. doi: 10.1111/iej.12134. Epub 2013 May 25.
- Background: PubMed 17249433Canoglu H, Tekcicek MU, Cehreli ZC. Comparison of conventional, rotary, and ultrasonic preparation, different final irrigation regimens, and 2 sealers in primary molar root canal therapy. Pediatr Dent. 2006 Nov-Dec;28(6):518-23.
- Background: PubMed 24563173Fumes AC, Sousa-Neto MD, Leoni GB, Versiani MA, da Silva LA, da Silva RA, Consolaro A. Root canal morphology of primary molars: a micro-computed tomography study. Eur Arch Paediatr Dent. 2014 Oct;15(5):317-26. doi: 10.1007/s40368-014-0117-0. Epub 2014 Feb 22.
- Background: PubMed 18329573Kummer TR, Calvo MC, Cordeiro MM, de Sousa Vieira R, de Carvalho Rocha MJ. Ex vivo study of manual and rotary instrumentation techniques in human primary teeth. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2008 Apr;105(4):e84-92. doi: 10.1016/j.tripleo.2007.12.008.
- Background: PubMed 10925773Fuks AB. Pulp therapy for the primary and young permanent dentitions. Dent Clin North Am. 2000 Jul;44(3):571-96, vii.
- Background: PubMed 27301382Lee GH, McGrath C, Yiu CK. Developing clinical practice guidelines for caries prevention and management for pre-school children through the ADAPTE process and Delphi consensus. Health Res Policy Syst. 2016 Jun 14;14(1):44. doi: 10.1186/s12961-016-0117-0.
- Background: PubMed 25466329Moura-Netto C, Palo RM, Pinto LF, Mello-Moura AC, Daltoe G, Wilhelmsen NS. CT study of the performance of reciprocating and oscillatory motions in flattened root canal areas. Braz Oral Res. 2015;29:1-6. doi: 10.1590/1807-3107bor-2015.vol29.0006. Epub 2014 Dec 2.
- Background: PubMed 17183182Nagaratna PJ, Shashikiran ND, Subbareddy VV. In vitro comparison of NiTi rotary instruments and stainless steel hand instruments in root canal preparations of primary and permanent molar. J Indian Soc Pedod Prev Dent. 2006 Dec;24(4):186-91. doi: 10.4103/0970-4388.28075.
- Background: PubMed 22016313Neena IE, Ananthraj A, Praveen P, Karthik V, Rani P. Comparison of digital radiography and apex locator with the conventional method in root length determination of primary teeth. J Indian Soc Pedod Prev Dent. 2011 Oct-Dec;29(4):300-4. doi: 10.4103/0970-4388.86371.
- Background: PubMed 26992247Nobrega DF, Fernandez CE, Del Bel Cury AA, Tenuta LM, Cury JA. Frequency of Fluoride Dentifrice Use and Caries Lesions Inhibition and Repair. Caries Res. 2016;50(2):133-40. doi: 10.1159/000444223. Epub 2016 Mar 19.
- Background: PubMed 22188162Pinheiro SL, Araujo G, Bincelli I, Cunha R, Bueno C. Evaluation of cleaning capacity and instrumentation time of manual, hybrid and rotary instrumentation techniques in primary molars. Int Endod J. 2012 Apr;45(4):379-85. doi: 10.1111/j.1365-2591.2011.01987.x. Epub 2011 Dec 22.
- Individual participant dataSharing planned: Undecided. We are planning to share the individual data upon request, since the participants and their legal guardians consent.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renata Marques, PhD Student principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual instrumentation and Reciprocating Instrumentation in people with Endodontic Treatment of Primary Teeth, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success or failure of endodontic treatment (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03453658, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.