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

NCT03684915 | Unknown DMC

• 1 other identifier: CEBD-CU-2018-08-26
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Infection

Keywords

Rotary instrumentation; pulpectomy; primary teeth

Outcome Measures

Primary Outcomes (1)

• Resolution of fistula

  unit of measurement: Yes/No using visual examination

  3 months

Secondary Outcomes (1)

• assessment of tooth mobility

  3 months

Study Arms (2)

rotary files

EXPERIMENTAL

1. Pre-operative radiograph showing all roots and their apices. 2. Local anaesthetic (to enable use of rubber dam clamp). 3. Rubber dam isolation. 4. Removal of caries. 5. Removal of roof of pulp chamber. 6. Removal of any remains of coronal pulp tissue with sharp sterile excavator or large bur in slow hand piece. 7. Identify root canals. 8. Irrigate with normal saline (0.9%) 9. Estimate working lengths of root canals keeping 2 mm short of the radiographic apex. 10. Insert rotary files into canals and debride the canals lightly and gently. 11. Irrigate the root canals. 12. Dry canals with pre-measured paper points, keeping 2 mm from root apices. 13. Canals will be dried with paper points, obturated by injecting Metapex. (Meta Biomed - Metapex Root Canal Filling Material) 14. Stainless steel crown will be performed

Device: Rotary files

manual files

ACTIVE COMPARATOR

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

Interventions

Rotary files DEVICE

using rotary files in cleaning root canals of infected primary molars

manual files; rotary files

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Persistent Infection

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Basma Mohamed Zakaria, B.D.S

CONTACT

00201120006929; basma.mohamed@dentistry.cu.edu.eg

Rasha Adel Ragab, PHD

CONTACT

00201007505888; rashaadelragab@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator (Master Degree Student)

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 26, 2018
• Study Start: October 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: October 1, 2019
• Last Updated: September 26, 2018

Record last verified: 2018-09