Back to resultsSingle-file Pulpectomy in Primary Molars
Primary Purpose
Pulpal Necrosis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
One Shape Single-file rotary system
manual stainless steel K-file
Sponsored by
About this trial
This is an interventional treatment trial for Pulpal Necrosis focused on measuring Pulpectomy, Pediatric Dentistry
Eligibility Criteria
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
Sites / Locations
- Minia University, Faculty of Dentistry.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
One Shape Single-file rotary system
Manual stainless steel K-file
Arm Description
Outcomes
Primary Outcome Measures
Pain presence or absence
score 0 was applied for absence of pain and score 1 was applied for presence of pain
swelling presence or absence
score 0 was applied for absence of swelling and score 1 was applied for presence of swelling
radiographic success or failure
it was done using periapical radiograph and score 0 was applied for absence of radiolucency and score 1 was applied for presence of radiolucency
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04394702
Brief Title
Single-file Pulpectomy in Primary Molars
Official Title
Efficacy of One-Shape Single-file System in Pulpectomy of Infected Primary Molars: In-vitro and In-vivo Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
December 22, 2019 (Actual)
Study Completion Date
March 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulpal Necrosis
Keywords
Pulpectomy, Pediatric Dentistry
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
One Shape Single-file rotary system
Arm Type
Experimental
Arm Title
Manual stainless steel K-file
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
One Shape Single-file rotary system
Intervention Description
rotational single file system used for mechanical debridement of root canals
Intervention Type
Other
Intervention Name(s)
manual stainless steel K-file
Intervention Description
sequential manual filing with stainless steel K-files
Primary Outcome Measure Information:
Title
Pain presence or absence
Description
score 0 was applied for absence of pain and score 1 was applied for presence of pain
Time Frame
one year
Title
swelling presence or absence
Description
score 0 was applied for absence of swelling and score 1 was applied for presence of swelling
Time Frame
one year
Title
radiographic success or failure
Description
it was done using periapical radiograph and score 0 was applied for absence of radiolucency and score 1 was applied for presence of radiolucency
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Minia University, Faculty of Dentistry.
City
Minya
ZIP/Postal Code
61517
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Single-file Pulpectomy in Primary Molars
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