Pulpal NecrosisNCT04394702
Single-file Pulpectomy in Primary Molars
A study testing One Shape Single-file rotary system and manual stainless steel K-file in people with Pulpal Necrosis, run by Minia University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpal Necrosis
- What is being tested?
- One Shape Single-file rotary system and manual stainless steel K-file
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2017to 2 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of One-Shape Single-file System in Pulpectomy of Infected Primary Molars: In-vitro and In-vivo Randomized Controlled Trial.
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.
- Conditions
- Pulpal Necrosis
- Being tested
- One Shape Single-file rotary system, manual stainless steel K-file
- Keywords
- Pulpectomy, Pediatric Dentistry
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One Shape Single-file rotary systemOther
rotational single file system used for mechanical debridement of root canals
manual stainless steel K-fileOther
sequential manual filing with stainless steel K-files
| Study group | Role | What they receive |
|---|---|---|
| One Shape Single-file rotary system | Experimental | Not described Receives: Other: One Shape Single-file rotary system |
| Manual stainless steel K-file | Active comparator | Not described Receives: Other: manual stainless steel K-file |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain presence or absence
score 0 was applied for absence of pain and score 1 was applied for presence of pain
Measured: one year
swelling presence or absence
score 0 was applied for absence of swelling and score 1 was applied for presence of swelling
Measured: one year
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start15 Jun 2017
- Primary completion22 Dec 2019
- Study completion2 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulpal NecrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Seif El-Nasr Hussein Gad El-Hak, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394702
- Sponsor's protocol ID
- 42/183/11/2016
- Status last verified
- May 2020
- First submitted
- 10 May 2020
- Last updated
- 19 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of One-Shape Single-file System in Pulpectomy of Infected Primary Molars: In-vitro and In-vivo Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04394702
- Acronym / sponsor ID
- 42/183/11/2016
- Conditions
- Pulpal Necrosis
- Keywords
- Pulpectomy, Pediatric Dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 22 Dec 2019 (actual)
- Study completion
- 2 Mar 2020 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One Shape Single-file rotary system | Experimental | Other: One Shape Single-file rotary system |
| Manual stainless steel K-file | Active comparator | Other: manual stainless steel K-file |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One Shape Single-file rotary systemrotational single file system used for mechanical debridement of root canals | Other | One Shape Single-file rotary system |
| manual stainless steel K-filesequential manual filing with stainless steel K-files | Other | Manual stainless steel K-file |
Primary outcome
Pain presence or absence
Time frame: one year
score 0 was applied for absence of pain and score 1 was applied for presence of pain
swelling presence or absence
Time frame: one year
score 0 was applied for absence of swelling and score 1 was applied for presence of swelling
radiographic success or failure
Time frame: one year
it was done using periapical radiograph and score 0 was applied for absence of radiolucency and score 1 was applied for presence of radiolucency
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One Shape Single-file rotary system and manual stainless steel K-file in people with Pulpal Necrosis, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain presence or absence (time frame: one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020.