Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
94 participants
INTERVENTIONAL
2017-06-15
2020-03-02
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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One Shape Single-file rotary system
One Shape Single-file rotary system
rotational single file system used for mechanical debridement of root canals
Manual stainless steel K-file
manual stainless steel K-file
sequential manual filing with stainless steel K-files
Interventions
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One Shape Single-file rotary system
rotational single file system used for mechanical debridement of root canals
manual stainless steel K-file
sequential manual filing with stainless steel K-files
Eligibility Criteria
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Inclusion Criteria
* 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
* Sever intellectual, behaviour or emotional problems
* Non-restorable tooth crowns
* Root canal obliteration
* Presence of underlying dentigerous or follicular cysts
4 Years
6 Years
ALL
Yes
Sponsors
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Minia University
OTHER
Responsible Party
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Osama Seif El-Nasr Hussein Gad El-Hak
assistant lecturer
Locations
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Minia University, Faculty of Dentistry.
Minya, , Egypt
Countries
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Other Identifiers
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42/183/11/2016
Identifier Type: -
Identifier Source: org_study_id
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