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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03684915
Enrollment
50
Registered
2018-09-26
Start date
2018-10-01
Completion date
2019-10-31
Last updated
2018-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Infection

Keywords

Rotary instrumentation, pulpectomy, primary teeth

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.

Interventions

DEVICERotary files

using rotary files in cleaning root canals of infected primary molars

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Resolution of fistula3 monthsunit of measurement: Yes/No using visual examination

Secondary

MeasureTime frameDescription
assessment of tooth mobility3 monthsunit 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

Contacts

Primary ContactBasma Mohamed Zakaria, B.D.S
basma.mohamed@dentistry.cu.edu.eg00201120006929
Backup ContactRasha Adel Ragab, PHD
rashaadelragab@gmail.com00201007505888

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026