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

Chronic Infection Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03684915
• Other study ID #: CEBD-CU-2018-08-26
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: October 2019

Study information

• Verified date: September 2018
• Source: Cairo University
• Contact: Basma Mohamed Zakaria, B.D.S
• Phone: 00201120006929
• Email: basma.mohamed[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Infection

Intervention

Device:
• Rotary files
using rotary files in cleaning root canals of infected primary molars

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of fistula	unit of measurement: Yes/No using visual examination	3 months
Secondary	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