Iatrogenic Perforation of Primary MolarsNCT04137861
Evaluation of Furcal Perforation Repair in Primary Molars With MTA Versus Bioceramics (A Randomized Clinical Trial)
A study testing Bioceramics in people with Iatrogenic Perforation of Primary Molars, run by Ahmad Elheeny at 1 site in Egypt.
Trial summary
Furcal perforation is one of the most challenging procedural accidents during pulpotomy of primary molars and should be sealed as soon as possible to prevent bacterial invasion at perforation site and subsequent tooth extraction. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Iatrogenic Perforation of Primary Molars
- What is being tested?
- Bioceramics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Oct 2019to 25 Oct 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 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Apparently healthy children aged from 4 to 7 years
- No history of spontaneous pain or swelling
- No signs or symptoms of irreversible pulpits or loss of vitality
- Absence of radicular or priapical lesions.
- Accidental furcal perforation should be immediate or mediate (within two weeks) perforation in primary molars.
Who cannot join
- Children with systemic disease
- Presence of priapical lesions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Furcal Perforation Repair in Primary Molars With MTA Versus Bioceramics
Furcal perforation is one of the most challenging procedural accidents during pulpotomy of primary molars and should be sealed as soon as possible to prevent bacterial invasion at perforation site and subsequent tooth extraction. The aim of the study is to compare bioceramics versus MTA as root repair material for treatment of furcal perforation in primary molars
- Conditions
- Iatrogenic Perforation of Primary Molars
- Being tested
- Bioceramics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioceramicsOther
root repair material
| Study group | Role | What they receive |
|---|---|---|
| Mineral Trioxide Aggregate (MTA) | Active comparator | Root repair material Receives: Other: Bioceramics |
| bioceramics | Experimental | Root repair material Receives: Other: Bioceramics |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical success
Visual oral examination
Measured: 9 months
radiographic success
Radiolucency assessment (+/-)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start25 Oct 2019
- Primary completion25 Aug 2020
- Study completion25 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iatrogenic Perforation of Primary MolarsStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmad Elheeny
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmad Elheeny, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137861
- Sponsor's protocol ID
- 308
- Status last verified
- Feb 2021
- First submitted
- 20 Oct 2019
- Last updated
- 25 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abdelmotelb MA, Gomaa YF, Khattab NMA, Elheeny AAH. Premixed bioceramics versus mineral trioxide aggregate in furcal perforation repair of primary molars: in vitro and in vivo study. Clin Oral Investig. 2021 Aug;25(8):4915-4925. doi: 10.1007/s00784-021-03800-3. Epub 2021 Jan 22.
PubMed 33483869
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Furcal Perforation Repair in Primary Molars With MTA Versus Bioceramics
- ClinicalTrials.gov ID
- NCT04137861
- Acronym / sponsor ID
- 308
- Conditions
- Iatrogenic Perforation of Primary Molars
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Ahmad ElheenyUniversity, hospital or other
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 25 Aug 2020 (actual)
- Study completion
- 25 Oct 2020 (actual)
- First posted
- 24 Oct 2019 (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.
Furcal perforation is one of the most challenging procedural accidents during pulpotomy of primary molars and should be sealed as soon as possible to prevent bacterial invasion at perforation site and subsequent tooth extraction. The aim of the study is to compare bioceramics versus MTA as root repair material for treatment of furcal perforation in primary molars
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mineral Trioxide Aggregate (MTA) | Active comparator | Other: BioceramicsRoot repair material |
| bioceramics | Experimental | Other: BioceramicsRoot repair material |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Apparently healthy children aged from 4 to 7 years
- No history of spontaneous pain or swelling
- No signs or symptoms of irreversible pulpits or loss of vitality
- Absence of radicular or priapical lesions.
- Accidental furcal perforation should be immediate or mediate (within two weeks) perforation in primary molars.
Key exclusion criteria (2 listed)
- Children with systemic disease
- Presence of priapical lesions
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 |
|---|---|---|
| Bioceramicsroot repair material | Other | Mineral Trioxide Aggregate (MTA), bioceramics |
Primary outcome
clinical success
Time frame: 9 months
Visual oral examination
radiographic success
Time frame: 9 months
Radiolucency assessment (+/-)
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 25 Feb 2021.
- Derived from this study: PubMed 33483869Abdelmotelb MA, Gomaa YF, Khattab NMA, Elheeny AAH. Premixed bioceramics versus mineral trioxide aggregate in furcal perforation repair of primary molars: in vitro and in vivo study. Clin Oral Investig. 2021 Aug;25(8):4915-4925. doi: 10.1007/s00784-021-03800-3. Epub 2021 Jan 22.
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 Bioceramics in people with Iatrogenic Perforation of Primary Molars, run by Ahmad Elheeny 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 5 inclusion and 2 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 25 Feb 2021. 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?
clinical success (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04137861, which also lists 1 linked publication.
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 25 Feb 2021.