Pulpectomy of Primary Molars With Rotary Instrumentation Versus Manual Instrumentation

Postoperative Pain Following Pulpectomy of Primary Molars With Rotary Instrumentation Versus Manual Instrumentation: A Randomized Clinical Trial

One of the major concerns in pediatric dentistry is premature loss of necrotic primary teeth which may cause a deleterious effect on the growth of the facial skeletal complex. In order to sustain the primary tooth as a natural space maintainer, pulpectomy is considered the treatment of choice.

The essential part of endodontic treatment is to shape and clean the root canal effectively from infected tissue with microbial reduction, whilst maintaining the original configuration without creating any procedural errors . Even though, manual instrumentation as used for that purpose in deciduous teeth, presents some limitation concerning root canal cleaning, anatomical fidelity and chair-side time.

To achieve successful pulpectomy technique for the primary dentition in a fast and simple procedure, with short chair time as well as effective debridement of the root canals, rotary instrumentation is one of the methods recommended over the manual.

Study Overview

• Status: Unknown
• Conditions: Infection; Chronic
• Intervention / Treatment: Device: Rotary instrumentation; Device: Hand instrumentation

Detailed Description

1. Trial design:

   Randomized clinical trial, parallel groups design with 1:1 allocation ratio.

2. Method:

   Interventions

   A. Diagnostic procedure:

   • Clinical examination will be done on the dental clinic using mirror and probe to assess the eligibility.
   • Diagnosis of the cases will be performed according to guidelines of AAPD 2017 for treatment of vital pulp therapy in primary teeth.
   • An individual XCP (Extension Cone Paralleling) index will be prepared for each patient by registering the bite to allow consistent comparisons of the radiographs.
   • Preoperative periapical radiograph and photographs will be taken a baseline record.

   B. Intra operative procedure:

   • Local anesthesia administration using articaine 4% with epinephrine 1:100000.
   • Rubber dam application and access cavity preparation will be established using a sterile bur.
   • Coronal pulp tissue will be removed using sharp large spoon excavator.
   • Working length will be determined using no 15 hand K-file that will be kept 2mm short of radiographic apex.

   • Then, the root canal preparation will be done

     • In control group, hand instrumentation will be carried out using hand K-file up to no. 30 K-file using quarter turn and pull motion.
     • In intervention group, rotary instrumentation will be preceded by initial hand instrumentation using no. 15 K-file to check the patency. Then, the rotary instrumentation will be done using the Kedo-S rotary files for primary teeth with D1 and E1.
   • Using EDTA gel as a lubricating paste during canal preparation with rotary files.
   • Saline irrigation for removal of debris after each file.
   • Dryness will be done using paper points size 35 and 40.
   • Root canals will be obturated using calcium hydroxide iodoform paste (Metapex). The Metapex syringe willbe inserted into the root canal space, near the apex. The paste will be pressed down into the canals and the syringe will be slowly withdrawn.
   • The access cavity will be sealed using GC Fuji IX capsule.
   • The immediate postoperative radiograph will be done to reveal optimal filling with metapex.
   • After that, stainless steel crowns will be cemented by Ketac Cem.

   C. Follow up:

   Clinical and radiographic evaluation will be performed at 1week, 3, 6, 9 and 12 months.

   D. Criteria for discontinuing or modifying intervention:

   In case of unsuccessful outcomes of the intervention technique, the case will be managed .

3. Recruitment:

   Recruitment of the patients will be from the outpatient clinic of Pediatric Dentistry and Dental Public Health Department, Cairo University. Screening of patients will continue until the target population is achieved.

4. Implementation Co-supervisor; Fatma Korany will assign which participant tooth will be included to either control or intervention groups according to the generated random sequence.
5. Masking/blinding:

The radiographic outcomes assessor will be blinded in this study. 8- Data collection, management, and analysis: 9- Data collection methods

Baseline data will be collected by the operator through a paper-based Case Report custom made form (CRF) which will be developed by the research team. It will include the following items:

1. Patient serial number.
2. Demographic data.

3. Patients medical history:

   • Past medical history.
   • Any present disease or illness.
   • Current medication.
   • Any specific pre-treatment medication.
4. Past dental history.
5. Records for current dental condition (intra-oral examination and caries index). The custom made CRF will be developed before online registration of the study protocol. CRF will be anonymous where patients will be identified by their serial number. The full detailed personal data of the patient will be written in a separate sheet having the patient's serial number for further contact with patient, this sheet can be only seen by the operator and the supervisors. The Co-supervisor; Dr.Fatma Korany, will have the role to monitor the process of data collection and check if there is any incomplete CRF.

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 6 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Primary posterior teeth requiring pulpectomy.
• Cooperative patient in age range from 4 to 6 years
• Absence of internal or external pathologic root resorption.
• Presence of adequate coronal tooth structure.
• Two-thirds of each root remaining.
• Parent or guardian agree for participant in the study

Exclusion Criteria:

• Excessive mobility.
• Children lacking cooperative ability.
• Children with underlying systemic disease.
• Children with special health care needs.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rotary instrumentation; endodontic treatment will be performed with the use of pedo rotary files that will be activated by engine	Device: Rotary instrumentation; using pedo rotary files in cleaning and shaping the root canals of infected primary molars
Active Comparator: hand istrumentation; endodontic treatment will be performed with the use of conventional hand files	Device: Hand instrumentation; using conventional hand files in cleaning and shaping the root canals of infected primary molars

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain: modified wong-baker pain rating scale	pain will be assessed using modified wong-baker pain rating scale (0-3),(zero)-no pain; ( one)-slight pain; (two)-moderate pain; and (three)-severe pain.	12 hours
postoperative pain: modified wong-baker pain rating scale	pain will be assessed using modified wong-baker pain rating scale (0-3),(zero)-no pain; ( one)-slight pain; (two)-moderate pain; and (three)-severe pain.	24 hours
postoperative pain: modified wong-baker pain rating scale	pain will be assessed using modified wong-baker pain rating scale (0-3),(zero)-no pain; ( one)-slight pain; (two)-moderate pain; and (three)-severe pain.	48 hours
Postoperative pain: modified wong-baker pain rating scale	pain will be assessed using modified wong-baker pain rating scale (0-3),(zero)-no pain; ( one)-slight pain; (two)-moderate pain; and (three)-severe pain.	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tenderness to percussion	Percussion test ,Binary (+/-)	Up to 1 year
Fistula	Visual examination by operator,Binary (+/-)	Up to 1 year
Instrumentation time	The time spent using both techniques will be measured and compared between the groups. The time will be recorded in minutes using a stopwatch since the beginning of instrumentation until the beginning of restorative procedure.	15 Minutes
Furcation or periapical radiolucency	Digital Radiograph ,Binary (+/-)	6 month
Furcation or periapical radiolucency	Digital Radiograph ,Binary (+/-)	12 month

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Fatma Abdelgawad, PhD, Lecturer of Pediatric Dentistry; Study Chair: Kamal El Motayam, PhD, Professor of Pediatric Dentistry

Publications and helpful links

General Publications

• Panchal V, Jeevanandan G, Subramanian E. Comparison of instrumentation time and obturation quality between hand K-file, H-files, and rotary Kedo-S in root canal treatment of primary teeth: A randomized controlled trial. J Indian Soc Pedod Prev Dent. 2019 Jan-Mar;37(1):75-79. doi: 10.4103/JISPPD.JISPPD_72_18.
• Makarem A, Ravandeh N, Ebrahimi M. Radiographic assessment and chair time of rotary instruments in the pulpectomy of primary second molar teeth: a randomized controlled clinical trial. J Dent Res Dent Clin Dent Prospects. 2014 Spring;8(2):84-9. doi: 10.5681/joddd.2014.015. Epub 2014 Jun 11.
• Panchal V, Jeevanandan G, Subramanian EMG. Comparison of post-operative pain after root canal instrumentation with hand K-files, H-files and rotary Kedo-S files in primary teeth: a randomised clinical trial. Eur Arch Paediatr Dent. 2019 Oct;20(5):467-472. doi: 10.1007/s40368-019-00429-5. Epub 2019 Mar 12.

Helpful Links

• Pinheiro, S., Santos, N. & Imparato, J. (2012) Analysis of the instrumentation time and cleaning between manual and rotary techniques in deciduous molars. Rsbo, 9 (3), pp.238-244.
• Ochoa-Romero, T., Veronica Mendez-Gonzalez, H.F.-R. & Pozos-Guillen, A.J. (2011) Comparison Between Rotary and Manual Techniques on Duration of Instrumentation and Obturation Times in Primary Teeth.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2019
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: May 16, 2019
• First Submitted That Met QC Criteria: May 24, 2019
• First Posted (Actual): May 28, 2019

Study Record Updates

• Last Update Posted (Actual): July 19, 2019
• Last Update Submitted That Met QC Criteria: July 17, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Pulpectomy; Primary molar; rotary files
• Other Study ID Numbers: 200277

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: after thesis defense. the study will be published internationally to be available for everyone
• IPD Sharing Time Frame: study will be available within 2 year.
• IPD Sharing Access Criteria: Not yet
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No