deltatrials
Completed NA INTERVENTIONAL 3-arm NCT05619796

Assessment of Clinical & Radiographic Efficiency of Manual & Pediatric Rotary Systems in Primary Root Canal Preparation

Assessment of Clinical and Radiographic Efficiency of Manual and Pediatric Rotary File Systems in Primary Root Canal Preparation

Sponsor: Tanta University

Updated 7 times since 2022 Last updated: Dec 5, 2023 Started: Sep 4, 2022 Primary completion: Mar 4, 2023 Completion: Jul 30, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A NA clinical study on Manual; Rotation and Obturation, this trial is completed. The trial is conducted by Tanta University and has accumulated 7 data snapshots since 2022. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

Biomechanical preparation is one of the most important steps of primary teeth pulpectomy, which are primarily targeted during canal debridement . Conventionally, hand files were used for cleaning and shaping in primary teeth with some disadvantages such as time wastage and the occurrence of iatrogenic errors such as zipping, lateral perforations, apical obstruction, and canal transportation. The use of rotary instruments for primary tooth instrumentation is faster, affordable, and yields consistent, reliable results. Numerous rotary endodontic systems designed primarily for application in permanent teeth, have been suggested for primary teeth root canal preparation. Since the primary teeth have a ribbon-shaped anatomy and shorter, thinner curved roots than permanent teeth, the use of these files in pulpectomy of primary teeth could produce lateral perforations. As a result, there was a great need for the development of a unique pediatric rotary file system. The Kedo-S Square rotary system is a single file system specifically designed for paediatric use. It consists of two files, one for anterior primary teeth (A1) and one for posterior primary teeth (P1) also, Fanta AF™-Baby rotary system, another specifically generated paediatric rotary file, was produced using Ni-Ti controlled memory (CM)-Wire technology. A good root canal treatment in primary...

Biomechanical preparation is one of the most important steps of primary teeth pulpectomy, which are primarily targeted during canal debridement . Conventionally, hand files were used for cleaning and shaping in primary teeth with some disadvantages such as time wastage and the occurrence of iatrogenic errors such as zipping, lateral perforations, apical obstruction, and canal transportation.

The use of rotary instruments for primary tooth instrumentation is faster, affordable, and yields consistent, reliable results. Numerous rotary endodontic systems designed primarily for application in permanent teeth, have been suggested for primary teeth root canal preparation. Since the primary teeth have a ribbon-shaped anatomy and shorter, thinner curved roots than permanent teeth, the use of these files in pulpectomy of primary teeth could produce lateral perforations. As a result, there was a great need for the development of a unique pediatric rotary file system.

The Kedo-S Square rotary system is a single file system specifically designed for paediatric use. It consists of two files, one for anterior primary teeth (A1) and one for posterior primary teeth (P1) also, Fanta AF™-Baby rotary system, another specifically generated paediatric rotary file, was produced using Ni-Ti controlled memory (CM)-Wire technology.

A good root canal treatment in primary teeth is dependent on the quality of biomechanical preparation, the type of obturating material used with as few voids as possible, and the achievement of a good hermetic seal. Also, treatment time is an important aspect as reduced chairside time increases children's cooperation for dental treatment, reduces anxiety, and making the treatment protocol optimal. Another factor affecting the success of primary teeth pulpectomy is the postoperative pain which may be due to extrusion of foreign particles into peri-radicular tissues accordingly, causing inflammation and releasing inflammatory mediators.

Status Flow

~Dec 2022 – ~May 2023 · 5 months · monthly snapshotRecruiting~May 2023 – ~Aug 2023 · 3 months · monthly snapshot~Aug 2023 – ~Jan 2024 · 5 months · monthly snapshotRecruiting~Jan 2024 – ~Jul 2024 · 6 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshot

Change History

7 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed NA

  2. Sep 2024 — Present [monthly]

    Completed NA

  3. Jul 2024 — Sep 2024 [monthly]

    Completed NA

  4. Jan 2024 — Jul 2024 [monthly]

    Completed NA

    Status: RecruitingCompleted

  5. Aug 2023 — Jan 2024 [monthly]

    Recruiting NA

Show 2 earlier versions
  1. May 2023 — Aug 2023 [monthly]

    Recruiting NA

  2. Dec 2022 — May 2023 [monthly]

    Recruiting NA

    First recorded

Sep 2022

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Tanta University
Data source: Tanta University

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations