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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Chronic Infection

Intervention / Treatment
-----------------
* Device: Rotary files


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rotary files<br>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<br>* using rotary files in cleaning root canals of infected primary molars<br>|
| Active Comparator: manual files<br>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<br>* using rotary files in cleaning root canals of infected primary molars<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rotary instrumentation, pulpectomy, primary teeth