ClinicalTrials.gg
Status unknownNCT03684915Updated Sep 26, 2018

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

An interventional study of Rotary files in Chronic Infection, sponsored by Cairo University. Status unknown. Open to participants aged 4 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-26.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
4 Years to 12 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Infection

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Keywords

  • Rotary instrumentation
  • pulpectomy
  • primary teeth
03

In context

Persistent Infection

44 studies on the registry are indexed under Persistent Infection; 5 are open to participants now.

This study's planned enrollment of 50 is below the median of 104 across 28 interventional studies indexed under Persistent Infection.

Browse Persistent Infection studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • teeth with non-restorable crowns
  • expected shedding time within one year
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    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

    Device: Rotary files

  • Active comparator
    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

    Device: Rotary files

Interventions

  • DeviceRotary files

    using rotary files in cleaning root canals of infected primary molars

06

What researchers measure

Primary outcomes

  1. Resolution of fistula

    unit of measurement: Yes/No using visual examination

    Time frame: 3 months

Secondary outcomes

  1. 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

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2018; primary completion for Apr 2019, 6 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 10, 2018
First posted
Sep 26, 2018
StartEst.
Oct 1, 2018
Primary completionEst.
Apr 2019
CompletionEst.
Oct 2019
Last update
Sep 26, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03684915
Lead sponsor
Cairo University
Responsible party
Basma Mohamed Zakaria Ahmed Zain (Principal investigator (Master Degree Student), Cairo University) — Principal investigator
First posted
Sep 26, 2018
Start date
Oct 1, 2018 (estimated)
Primary completion
Apr 2019 (estimated)
Completion
Oct 2019 (estimated)
Last update
Sep 26, 2018

Study contacts

Basma Mohamed Zakaria, B.D.S
Contact
basma.mohamed@dentistry.cu.edu.eg
00201120006929
Rasha Adel Ragab, PHD
Contact
rashaadelragab@gmail.com
00201007505888

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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