Clinical Post-operative Assessment of Chronic Signs & Symptoms Related to Infected Primary Molars After Using Rotary Versus Manual Systems in Cleaning the Root Canals

Clinical Post-operative Assessment of Chronic Signs & Symptoms Related to Infected Primary Molars After Using Rotary Versus Manual Systems in Cleaning the Root Canals: A Randomized Clinical Trial

One of the most important concerns in pediatric dentistry is the loss of necrotic primary molars leading to space loss. pulpectomies for primary teeth with severe pulpal involvement should be considered as the treatment of choice.

Bacteria plays an essential role in the initiation and perpetuation of pulpal and periapical disease. The investigator's target when cleaning and shaping the root canal system is to remove bacteria-containing tissue.

The removal of organic debris is the main purpose of instrumentation in pulpectomy procedures in primary teeth, this could be achieved using manual or rotary Ni-Ti files. A practical pulpectomy technique for the primary teeth should include the following:1) Fast procedure with short treatment time and minimal number of appointments.2) Effective debridement of the root canal without weakening the tooth structure or endangering the underlining permanent teeth.3) Minimal procedural complications. 4) Maintaining tooth function until it is naturally exfoliated.

Manufacturers using rotary files highlight their cleaning efficiency for root canal preparations, simple procedures, and decreased procedure time, which is especially important in children.

Considering that preparation time is an important clinical factor in pediatric patient management, the use of rotary instruments for pulpectomies in primary teeth is recommended.

Study Overview

• Status: Unknown
• Conditions: Chronic Infection
• Intervention / Treatment: Device: Rotary files

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• primary molars with fistula / chronic abscess
• teeth which if lost possibility of space maintainer construction exists
• pre-operative radiograph showing absence of severe root resorption

Exclusion Criteria:

• teeth with non-restorable crowns
• expected shedding time within one year

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rotary files; Pre-operative radiograph showing all roots and their apices.; Local anaesthetic (to enable use of rubber dam clamp).; Rubber dam isolation.; Removal of caries.; Removal of roof of pulp chamber.; Removal of any remains of coronal pulp tissue with sharp sterile excavator or large bur in slow hand piece.; Identify root canals.; Irrigate with normal saline (0.9%); Estimate working lengths of root canals keeping 2 mm short of the radiographic apex.; Insert rotary files into canals and debride the canals lightly and gently.; Irrigate the root canals.; Dry canals with pre-measured paper points, keeping 2 mm from root apices.; Canals will be dried with paper points, obturated by injecting Metapex. (Meta Biomed - Metapex Root Canal Filling Material); Stainless steel crown will be performed	Device: Rotary files; using rotary files in cleaning root canals of infected primary molars
Active Comparator: manual files; All steps as that of intervention group are to be followed except step (j) instead of it; a manual files will be inserted into the canals for debridement lightly and gently	Device: Rotary files; using rotary files in cleaning root canals of infected primary molars

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resolution of fistula	unit of measurement: Yes/No using visual examination	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of tooth mobility	unit of measurements : grades from 0-3 ,assessed by moving the tooth using two instruments ,one on the facial & the other on the lingual surfaces of the tooth	3 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2018
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: September 10, 2018
• First Submitted That Met QC Criteria: September 24, 2018
• First Posted (Actual): September 26, 2018

Study Record Updates

• Last Update Posted (Actual): September 26, 2018
• Last Update Submitted That Met QC Criteria: September 24, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: primary teeth; pulpectomy; Rotary instrumentation
• Other Study ID Numbers: CEBD-CU-2018-08-26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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