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

NCT ID: NCT03684915

Last Updated: 2018-09-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2019-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

rotary files

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

Group Type: EXPERIMENTAL

Rotary files

Intervention Type: DEVICE

using rotary files in cleaning root canals of infected primary molars

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

Group Type: ACTIVE_COMPARATOR

Rotary files

Intervention Type: DEVICE

using rotary files in cleaning root canals of infected primary molars

Interventions

Rotary files

using rotary files in cleaning root canals of infected primary molars

Intervention Type: DEVICE

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Basma Mohamed Zakaria Ahmed Zain

Principal investigator (Master Degree Student)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Basma Mohamed Zakaria, B.D.S

Role: CONTACT

basma.mohamed@dentistry.cu.edu.eg

00201120006929

Rasha Adel Ragab, PHD

Role: CONTACT

rashaadelragab@gmail.com

00201007505888

Other Identifiers

CEBD-CU-2018-08-26

Identifier Type: -

Identifier Source: org_study_id