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Single-file Pulpectomy in Primary Molars

Efficacy of One-Shape Single-file System in Pulpectomy of Infected Primary Molars: In-vitro and In-vivo Randomized Controlled Trial.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04394702
Enrollment
94
Registered
2020-05-19
Start date
2017-06-15
Completion date
2020-03-02
Last updated
2020-05-19

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

Conditions

Pulpal Necrosis

Keywords

Pulpectomy, Pediatric Dentistry

Brief summary

The current study evaluates the rotational One Shape single-file system regarding clinical and radiographic outcomes in root canal treatment of infected primary molars. This randomized clinical trial was carried out on 94 primary molars on children in the age group from 4 to 6 years. The teeth selected for this study were randomly assigned into 2 groups according to the used endodontic preparation system. Group I: 47 primary molars were instrumented with One Shape rotational single-file system. Group II: 47 primary molars were instrumented with stainless steel K-files. All teeth were evaluated clinically and radigraphically for 12 months with periodic recall at 3, 6 and 12 months.

Interventions

OTHEROne Shape Single-file rotary system

rotational single file system used for mechanical debridement of root canals

OTHERmanual stainless steel K-file

sequential manual filing with stainless steel K-files

Sponsors

Minia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
Yes

Inclusion criteria

* Children categorized as class I or II according to American Society of Anesthesiologists (ASA). * Children aged between 4 and 6 years with at least one necrotic primary second mandibular molar. * History of dull toothache over an extended period of time * History of spontaneous pain or pain at night * Swelling adjacent to tooth with or without a sinus tract * Abnormal tooth mobility * Presence of necrotic pulp tissue or purulent discharge when the pulp chamber was accessed * Interruption of lamina dura or thickening of periodontal ligament space * Furcational radiolucency did not surpass half of the distance between the furcation and permanent successor * Negative findings of internal root resorption * External root resorption confined to the apical third and with at least two-thirds of the root length was intact

Exclusion criteria

* Uncoperative children or parents/legal guardians * Sever intellectual, behaviour or emotional problems * Non-restorable tooth crowns * Root canal obliteration * Presence of underlying dentigerous or follicular cysts

Design outcomes

Primary

MeasureTime frameDescription
Pain presence or absenceone yearscore 0 was applied for absence of pain and score 1 was applied for presence of pain
swelling presence or absenceone yearscore 0 was applied for absence of swelling and score 1 was applied for presence of swelling
radiographic success or failureone yearit was done using periapical radiograph and score 0 was applied for absence of radiolucency and score 1 was applied for presence of radiolucency

Countries

Egypt

Outcome results

None listed

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