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Manual and Rotatory Instrumentation Pulpectomy in Primary Mandibular Molars (RotaPulp)

Primary Purpose

Dental Pulp Disease

Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Rotatory technique pulpectomy
Manual pulpectomy
Sponsored by
Universidad de Guanajuato
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Pulp Disease focused on measuring Pulp therapy, Rotatory system, Primary mandibular molar, Dental pulp cavity

Eligibility Criteria

4 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients between 4 to 8 years old.
  2. Both genders.
  3. Patients with an indication for pulpectomy for mandibular molars, based on the of Kuo and colleagues criteria (2006).
  4. Patients requiring pulpectomy in posterior teeth.
  5. Adequate dental structure of the crown.
  6. Patients with a remnant structure of at least two-thirds of the root.
  7. Patients with a medical file at the Pediatric Dentistry Clinic, Universidad Latinoamericana, Campus Valle.
  8. Patients with signed informed consent.

Exclusion Criteria:

  1. Patients requiring pulpotomy, extraction, or pulp regeneration therapy.
  2. Patients who are older than 9 years.
  3. An unrestorable tooth.
  4. Internal resorption in the roots visible on radiographs.
  5. Teeth with mechanical or carious perforations of the floor of the pulp chamber.
  6. Excessive pathologic root resorption involving more than a third of the root.
  7. Excessive pathologic loss of bone support, with loss of the normal periodontal attachment.
  8. Presence of a dentigerous or follicular cyst.
  9. Periapical or interradicular lesion involving the crypt of the developing permanent successor.
  10. Patients with the diagnosis of molar incisor hypomineralization (MIH).
  11. Patient's whose legal guardian does not provide their informed consent to participate in this study.
  12. Uncooperative patients.

Elimination criteria

a. Patients who do not complete the treatment or radiographic follow-up at least at a cut-off point.

Sites / Locations

  • Clínica de OdontopediatríaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Adult manual instrumentation

Pediatric manual instrumentation

Adult rotatory instrumentation

Pediatric rotatory instrumentation

Arm Description

Primary mandibular molars who are treated with a manual pulpectomy and a K-file system.

Primary mandibular molars treated with a manual pulpectomy and a Kedo-SH system.

Primary mandibular molars treated with a rotatory technique pulpectomy and a K3 system.

Primary mandibular molars treated with a rotatory technique pulpectomy and a Kedo-S system

Outcomes

Primary Outcome Measures

Instrumentation time
The time needed to shape the root canal.
Obturation time
Time needed to obturate the root canals.
Filling quality
Radiographic evaluation of the root canal filling.
Postoperative pain
Pain resulting from the surgical procedure, evaluated with the visual analog pain scale (range, 1 to 10; the higher the score the worst the outcome).
Postoperative pain
Pain resulting from the surgical procedure, evaluated with the visual analog pain scale (range, 1 to 10; the higher the score the worst the outcome).

Secondary Outcome Measures

Complications secondary to procedure
Frequency of fistulas, thinning of the mesiodistal walls, periapical or furcation radiolucency, among other possible complications
Complications secondary to procedure
Frequency of fistulas, thinning of the mesiodistal walls, periapical or furcation radiolucency, among other possible complications
Complications secondary to procedure
Frequency of fistulas, thinning of the mesiodistal walls, periapical or furcation radiolucency, among other possible complications
Complications secondary to procedure
Frequency of fistulas, thinning of the mesiodistal walls, periapical or furcation radiolucency, among other possible complications

Full Information

First Posted
November 10, 2020
Last Updated
December 8, 2020
Sponsor
Universidad de Guanajuato
Collaborators
Universidad Latinoamericana, University Medical Center Groningen
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1. Study Identification

Unique Protocol Identification Number
NCT04636450
Brief Title
Manual and Rotatory Instrumentation Pulpectomy in Primary Mandibular Molars
Acronym
RotaPulp
Official Title
Comparison Between Manual and Rotatory Instrumentation Pulpectomy Treatments in Primary Mandibular Molars
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 8, 2020 (Actual)
Primary Completion Date
December 15, 2021 (Anticipated)
Study Completion Date
July 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Guanajuato
Collaborators
Universidad Latinoamericana, University Medical Center Groningen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this study, the aim is to compare manual and rotatory pulpectomy techniques on 100 primary mandibular molars on children between the ages of 4 and 8 years. The plan is to conduct a randomized controlled trial with a 1:1 ratio for group allocation at a teaching university pediatric dentistry clinic between January 2021 and December 2021. Two manual systems, as well as two rotary systems, will be randomly assigned. The adult manual system used will be K-file and the adult rotary system will be K3. The pediatric manual system used in this study will be Kedo-SH, while the pediatric rotary system will be Kedo-S. The observed outcome measures in this study are the following: 1) instrumentation and filling time; 2) filling quality by radiographic evaluation; 3) postoperative pain levels using the visual analog scale at 12 and 24 hours; and 4) frequency of complications (e.g. fistulas, thinning of the mesiodistal walls, periapical or furcation radiolucency) after a 3-, 6-, 9-, and 12-month follow-up.
Detailed Description
Introduction Dental caries is a prevalent chronic disease, affecting 60-90% of school-age children in industrialized countries; although in the last four decades the prevalence and severity of caries lesions have decreased, it is still a frequent disease for this age group. The American Dental Association (ADA) classifies dental caries by clinical presentation as initial, moderate, and severe; furthermore, the ADA classifies the disease using the international caries detection and diagnosis system (ICDAS II; International Caries Detection and Assessment System II) and by a radiographic presentation of the proximal faces based on the E0-E2, D1-D3 notation system. Within the non-vital pulp treatments, pulpectomy is indicated in temporary teeth; pulpectomy is a conventional endodontic treatment for teeth with exposed, infected, and/or necrotic tissue to eliminate pulp and periradicular infection. In a recent systematic review that compared three different strategies for the management of deep caries lesions (i.e. complete caries removal, selective caries removal, and step caries removal), Aïem and colleagues (2020) report an increased restoration failure risk when selective removal is used compared to complete removal of caries. In a study where French dentists were surveyed on the management of deep caries lesions in primary dentition, the majority of respondents mentioned performing deep caries removal in a single step. Endodontic procedures in the pediatric population can assist to keep temporary teeth until exfoliation, which is a key principle of pediatric dentistry. Vital pulp and non-vital pulp treatments are employed in the treatment of severe lesions and deep caries; meanwhile, pulpectomy is a treatment largely used in the primary dentition. In pulp therapy, a pulpotomy is performed by removing the pulp from the chamber, while in a pulpectomy, all the tissue from both the chamber and the root canals is removed. There are two parameters used to determine root canal treatment success: 1) the morphology and shaping of the canal; and 2) the duct cleanliness or the adequate level of disinfection provided by the type and quantity of intra-canal irrigation (e.g. chlorhexidine, sodium hypochlorite, citric acid, profuse irrigation). A pulpectomy is the technique of choice for primary dentition in deep carious lesions with pulp necrosis since pulpectomy has a higher success rate than pulpotomy. While the time for access to the root canal is less with the use of rotary instrumentation systems compared to a manual technique, manual techniques have the same efficacy as rotary systems in root canal cleaning procedures. Rotary systems have greater clinical success compared to manual techniques, in addition to having advantages in instrumentation time, canal shaping, reduction in working time, better cooperation and less patient fatigue, improvement in the conicity of the root canal, and promoting a higher quality of obturation. In a recent meta-analysis, Manchanda and colleagues (2020) conclude that rotary instrumentation has similar clinical and radiographic success rates to manual techniques in primary dentition; additionally, rotatory techniques show lower levels of postoperative pain and less instrumentation time. In the only study in the Mexican population that compared a rotary system (i.e. K3) against a manual technique (i.e. K-file) it was found that the instrumentation and obturation time was shorter, being a promising technique in children. Given the limited comparative literature about rotatory techniques used in pulpectomy treatment, it is necessary to conduct clinical trials that compare both manual and rotatory techniques in first dentition treatment. So far, studies have been carried out comparing rotary systems designed for adults in the pediatric population. Recently, interest to validate and implement safe and effective protocols for the management of rotary systems in primary dentition has emerged in pediatric dentistry. Below is a protocol designed to investigate the advantages and disadvantages associated with the use of rotary systems designed for our population of interest. Study design Population: patients with pulpectomy indication according to the criteria mentioned by Kuo and colleagues (2006). Place: Pediatric Dentistry Clinic, Universidad Latinoamericana, Campus Valle. Time frame: January 2021 - December 2021 Sampling technique: convenience sampling with group randomization. Study groups: 4 (n= 100 teeth) Patients who are treated with a manual pulpectomy and a K-file system. Patients who are treated with a manual pulpectomy and a Kedo-SH system. Patients who are treated with a rotatory technique pulpectomy and a K3 system. Patients who are treated with a rotatory technique pulpectomy and a Kedo-S system. PICOS framework P: pediatric population I: manual system pulpectomy C: rotary system pulpectomy O: instrumentation and obturation time, filling quality by radiographic evaluation, postoperative pain levels at 12hr and 24hr, frequency of complications (e.g. fistulas, thinning of the mesiodistal walls, periapical or furcation radiolucency) after a 3-, 6-, 9-, and 12-month follow-up. S: a randomized controlled trial Research question Are there differences between the use of a manual system compared to a rotary system in the pediatric population? Main objective Compare the performance between a manual technique and a rotatory technique during biomechanical work. Particular objectives Compare the instrumentation (i.e. during biomechanical work) and filling time between a manual technique and a rotatory technique. Compare the filling quality by radiographic evaluation between a manual technique and a rotatory technique at the end of the procedure. Compare postoperative pain levels using the visual analog scale at 12 and 24 hours. Compare the frequency of complications (e.g. fistulas, thinning of the mesiodistal walls, periapical or furcation radiolucency) after a 3-, 6-, 9-, and 12-month follow-up between the two techniques. Hypotheses H1: The rotatory techniques will take less instrumentation and obturation time than the manual techniques. H1: The quality of the obturation in the rotatory technique will be reported radiographically more frequently as optimal than the manual technique. H1: The pain levels reported by patients will be lower in the rotatory technique than in the manual technique. H1: The rotatory technique will have a lower frequency of complications such as fistulas, thinning of the mesiodistal walls, periapical or furcation radiolucency at each time point compared to the manual technique. Statistical analysis Descriptive statistics will be performed on all variables. Statistical analysis will be performed using SPSS 25 (SPSS Inc., Chicago, IL). All variables will be examined to determine the existence of outliers and whether or not they meet the Gaussian distribution assumption; furthermore, Gaussian distribution will be determined with the Shapiro-Wilk test and by visualizing the data through histograms and Q-Q graphs. The demographic and clinical variables will be summarized in proportions and percentages. Nominal variables will be evaluated with Chi-square tests to assess differences between groups. Categorical variables will be evaluated to determine statistical inferences with the Mann-Whitney test. Continuous variables will be assessed for statistical inferences using t-tests and Levene's test to assess variance equality. Statistical significance will be set at p= 0.05 and a Bonferroni correction will be made for multiple comparisons. Sample size The sample size necessary to detect statistically significant differences was calculated by taking the following parameters; α = 0.05 and statistical power of 0.8 (i.e. 1-β). For the calculation of the sample size, the time of instrumentation was used as a measure of clinical outcome. The sample was calculated based on the article by Ochoa-Romero and colleagues (2011) where instrumentation time was used as the primary outcome. The sample calculator used can be found on the website: https://clincalc.com/stats/samplesize.aspx. The calculator designed for two independent groups for continuous variables was selected, using the mean for each group (i.e. group 1: rotatory technique 1.7 minutes ± 0.5; group 2: manual technique 2.5 minutes ± 0.8) taking into account an enrollment 1:1 ratio for this study. The total sample size was 24 teeth (i.e. at least 6 teeth per group to find statistically significant differences in instrumentation time).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Pulp Disease
Keywords
Pulp therapy, Rotatory system, Primary mandibular molar, Dental pulp cavity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Outcomes Assessor
Masking Description
Only the outcome assessor will be blinded as the interventions can not be blinded to the participant and care provider.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adult manual instrumentation
Arm Type
Active Comparator
Arm Description
Primary mandibular molars who are treated with a manual pulpectomy and a K-file system.
Arm Title
Pediatric manual instrumentation
Arm Type
Experimental
Arm Description
Primary mandibular molars treated with a manual pulpectomy and a Kedo-SH system.
Arm Title
Adult rotatory instrumentation
Arm Type
Active Comparator
Arm Description
Primary mandibular molars treated with a rotatory technique pulpectomy and a K3 system.
Arm Title
Pediatric rotatory instrumentation
Arm Type
Experimental
Arm Description
Primary mandibular molars treated with a rotatory technique pulpectomy and a Kedo-S system
Intervention Type
Procedure
Intervention Name(s)
Rotatory technique pulpectomy
Intervention Description
Primary mandibular molars treated with a rotatory technique pulpectomy and a K3 system or a Kedo-S system.
Intervention Type
Procedure
Intervention Name(s)
Manual pulpectomy
Intervention Description
Primary mandibular molars treated with a manual pulpectomy and a K-file system or a Kedo-SH system.
Primary Outcome Measure Information:
Title
Instrumentation time
Description
The time needed to shape the root canal.
Time Frame
Minutes; intraoperative time.
Title
Obturation time
Description
Time needed to obturate the root canals.
Time Frame
Minutes, intraoperative time.
Title
Filling quality
Description
Radiographic evaluation of the root canal filling.
Time Frame
Immediately after surgical procedure.
Title
Postoperative pain
Description
Pain resulting from the surgical procedure, evaluated with the visual analog pain scale (range, 1 to 10; the higher the score the worst the outcome).
Time Frame
12 hours
Title
Postoperative pain
Description
Pain resulting from the surgical procedure, evaluated with the visual analog pain scale (range, 1 to 10; the higher the score the worst the outcome).
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Complications secondary to procedure
Description
Frequency of fistulas, thinning of the mesiodistal walls, periapical or furcation radiolucency, among other possible complications
Time Frame
3-months
Title
Complications secondary to procedure
Description
Frequency of fistulas, thinning of the mesiodistal walls, periapical or furcation radiolucency, among other possible complications
Time Frame
6-months
Title
Complications secondary to procedure
Description
Frequency of fistulas, thinning of the mesiodistal walls, periapical or furcation radiolucency, among other possible complications
Time Frame
9-months
Title
Complications secondary to procedure
Description
Frequency of fistulas, thinning of the mesiodistal walls, periapical or furcation radiolucency, among other possible complications
Time Frame
12-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients between 4 to 8 years old. Both genders. Patients with an indication for pulpectomy for mandibular molars, based on the of Kuo and colleagues criteria (2006). Patients requiring pulpectomy in posterior teeth. Adequate dental structure of the crown. Patients with a remnant structure of at least two-thirds of the root. Patients with a medical file at the Pediatric Dentistry Clinic, Universidad Latinoamericana, Campus Valle. Patients with signed informed consent. Exclusion Criteria: Patients requiring pulpotomy, extraction, or pulp regeneration therapy. Patients who are older than 9 years. An unrestorable tooth. Internal resorption in the roots visible on radiographs. Teeth with mechanical or carious perforations of the floor of the pulp chamber. Excessive pathologic root resorption involving more than a third of the root. Excessive pathologic loss of bone support, with loss of the normal periodontal attachment. Presence of a dentigerous or follicular cyst. Periapical or interradicular lesion involving the crypt of the developing permanent successor. Patients with the diagnosis of molar incisor hypomineralization (MIH). Patient's whose legal guardian does not provide their informed consent to participate in this study. Uncooperative patients. Elimination criteria a. Patients who do not complete the treatment or radiographic follow-up at least at a cut-off point.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marianela Hernández-Baños, DDS
Phone
+525545600120
Email
neladentist@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamín Franco Sánchez, DDS
Phone
+525526902586
Email
cdfranco@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamín Franco Sánchez, DDS
Organizational Affiliation
Universidad Latinoamericana
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marianela Hernández-Baños, DDS
Organizational Affiliation
Universidad Latinoamericana
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jaime D Mondragon, MD, MSc
Organizational Affiliation
University Medical Center Groningen, Universidad de Guanajuato
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clínica de Odontopediatría
City
Mexico City
ZIP/Postal Code
03100
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ismael Marin-Merchant, DDS
Phone
+5217224201733
Email
i-s-mael3@hotmail.com
First Name & Middle Initial & Last Name & Degree
Carla F Villasana-Escobedo, DDS
Phone
+525573735716
Email
cf.ve_1993@hotmail.com
First Name & Middle Initial & Last Name & Degree
Paola M Torres-Olivares, DDS
First Name & Middle Initial & Last Name & Degree
Nahiely Hernández-Espinoza, DDS
First Name & Middle Initial & Last Name & Degree
José A Almeida-Díaz, DDS
First Name & Middle Initial & Last Name & Degree
Thalia Palacios-Piedra, DDS
First Name & Middle Initial & Last Name & Degree
Matilde Z López-Rivera, DDS

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All anonymized patient data will be made available upon request.
IPD Sharing Time Frame
At the conclusion of the study.
IPD Sharing Access Criteria
Access granted by the principal investigators.
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Manual and Rotatory Instrumentation Pulpectomy in Primary Mandibular Molars

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