Tooth InjuriesNCT05006755
Comparison of Sealing Ability of MTA and Biodentine for Repairing of Furcal Perforation in Primary Molars
A study testing Mineral Trioxide Aggregate and Biodentine in people with Tooth Injuries, run by Amany hasanean Abd El sadek.
Trial summary
Preservation of the primary teeth is a mandatory issue for maintaining the integrity of the normal dentition and functioning till the eruption of the successors. furcal perforations may occur due to iatrogenic and non-iatrogenic causes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tooth Injuries
- What is being tested?
- Mineral Trioxide Aggregate and Biodentine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2021to 10 Sep 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Freshly extracted discarded primary molars
- Primary molars with intact furcation ( no caries, no perforation, no resorption )
- Physiologic root resorption not more than two-third of root length
Who cannot join
- Exfoliated primary molars
- Primary molars with internal resorption
- Primary molars with extensive tooth decay of the crown
- Primary molars with discoloration
- Cracked tooth
About this study
Official title: Comparison of Sealing Ability of Mineral Trioxide Aggregate and Biodentine for Reparing of Furcal Perforation in Primary Molars Using Scanning Electron Microscope: In Vitro Study
- Preservation of the primary teeth is a mandatory issue for maintaining the integrity of the normal dentition and functioning till the eruption of the successors.
- furcal perforations may occur due to iatrogenic and non-iatrogenic causes.
- Despite the high successful outcomes in perforation repair with MTA, there are some issues which prevent the clinicians from using it for many cases such as its very long setting time and its difficult manipulation.
- Biodentin could be used as an alternative to MTA in reparative treatment procedures due to its ability to provide a hermetic seal and durable restoration and thus an optimal sealing is expected.
- The importance of the trial lies in testing the sealing ability of Biodentine using scanning electron microscope. Biodentine has short setting time and is easier in manipulation than MTA which are major needs when dealing with pediatric patients to be able to give best results in short time.
Read the detailed description
- By immediate diagnosis and sealing of furcal perforations in primary molar teeth with a biocompatible material, the prognosis is usually favorable.
- MTA has high clinical efficacy, but there were some drawbacks which made it difficult for the clinicians to use it in many cases. The major ones being very long setting time and difficult manipulation.
- Biodentine has a good sealing ability, high compressive strengths, short setting time, biocompatibility, bioactivity and biomineralization properties that make it available to be used in endodontic repair procedures.
- 42 extracted primary molar teeth will be collected, sterilized and stored according to the Occupational Safety and Health Administration guidelines and regulations.
- A standard access cavity will be prepared in each tooth using a diamond bur and non-end cutting bur in high-speed handpiece with water spray. A 0.5 mm round bur will be used to standardize the size of furcal perforation, and the furcal involvement will be made on the center of the pulpal floor.
- After the furcal perforation, the blocks will randomly be divided into two groups
- Control group: MTA Group, Using amalgam applicator the material will be carried and sealed in the furcation site.
- Intervention group: Biodentin Group,The material will be scooped and applied on the perforation site.
- Outcome : sealing ability measurement method : scanning electron microscope unit of measurement : µm
- Conditions
- Tooth Injuries
- Being tested
- Mineral Trioxide Aggregate, Biodentine
- Medical subject headings
- Tooth Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mineral Trioxide AggregateCombination product
Also called MTA
Mineral Trioxide Aggregate stimulates cementoblasts to produce matrix for cementum formation and is biocompatible with the periradicular tissues thus shows a superior sealing ability when used in perforation repair
BiodentineCombination product
Biodentine has a good sealing ability, high compressive strengths, short setting time, biocompatibility, bioactivity and biomineralization properties that make it available to be used in endodontic repair procedures
| Study group | Role | What they receive |
|---|---|---|
| control group | Experimental | the group of primary molar teeth that will be treated in furcal perforation with Mineral Trioxide Aggregate Receives: Combination Product: Mineral Trioxide Aggregate |
| experimental group | Experimental | the group of primary molar teeth that will be treated in furcal perforation with Biodentine Receives: Combination Product: Biodentine |
What is being measured
The primary outcome is the main question the study is designed to answer.
sealing ability
- measured by scanning electron microscope
- Unit of measurement : µm
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start10 Sep 2021 (estimated)
- Primary completion10 Sep 2021 (estimated)
- Study completion10 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth InjuriesStudies 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
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amany hasanean Abd El sadek
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amany hasanean Abd El sadek, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006755
- Sponsor's protocol ID
- 1692
- Status last verified
- Aug 2021
- First submitted
- 9 Aug 2021
- Last updated
- 25 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sealing Ability of Mineral Trioxide Aggregate and Biodentine for Reparing of Furcal Perforation in Primary Molars Using Scanning Electron Microscope: In Vitro Study
- ClinicalTrials.gov ID
- NCT05006755
- Acronym / sponsor ID
- 1692
- Conditions
- Tooth Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Amany hasanean Abd El sadekUniversity, hospital or other
- Study start
- 10 Sep 2021 (estimated)
- Primary completion
- 10 Sep 2021 (estimated)
- Study completion
- 10 Sep 2022 (estimated)
- First posted
- 16 Aug 2021 (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.
- Preservation of the primary teeth is a mandatory issue for maintaining the integrity of the normal dentition and functioning till the eruption of the successors.
- furcal perforations may occur due to iatrogenic and non-iatrogenic causes.
- Despite the high successful outcomes in perforation repair with MTA, there are some issues which prevent the clinicians from using it for many cases such as its very long setting time and its difficult manipulation.
- Biodentin could be used as an alternative to MTA in reparative treatment procedures due to its ability to provide a hermetic seal and durable restoration and thus an optimal sealing is expected.
- The importance of the trial lies in testing the sealing ability of Biodentine using scanning electron microscope. Biodentine has short setting time and is easier in manipulation than MTA which are major needs when dealing with pediatric patients to be able to give best results in short time.
Detailed description
- By immediate diagnosis and sealing of furcal perforations in primary molar teeth with a biocompatible material, the prognosis is usually favorable.
- MTA has high clinical efficacy, but there were some drawbacks which made it difficult for the clinicians to use it in many cases. The major ones being very long setting time and difficult manipulation.
- Biodentine has a good sealing ability, high compressive strengths, short setting time, biocompatibility, bioactivity and biomineralization properties that make it available to be used in endodontic repair procedures.
- 42 extracted primary molar teeth will be collected, sterilized and stored according to the Occupational Safety and Health Administration guidelines and regulations.
- A standard access cavity will be prepared in each tooth using a diamond bur and non-end cutting bur in high-speed handpiece with water spray. A 0.5 mm round bur will be used to standardize the size of furcal perforation, and the furcal involvement will be made on the center of the pulpal floor.
- After the furcal perforation, the blocks will randomly be divided into two groups
- Control group: MTA Group, Using amalgam applicator the material will be carried and sealed in the furcation site.
- Intervention group: Biodentin Group,The material will be scooped and applied on the perforation site.
- Outcome : sealing ability measurement method : scanning electron microscope unit of measurement : µm
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Experimental | Combination Product: Mineral Trioxide Aggregatethe group of primary molar teeth that will be treated in furcal perforation with Mineral Trioxide Aggregate |
| experimental group | Experimental | Combination Product: Biodentinethe group of primary molar teeth that will be treated in furcal perforation with Biodentine |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Freshly extracted discarded primary molars
- Primary molars with intact furcation ( no caries, no perforation, no resorption )
- Physiologic root resorption not more than two-third of root length
Key exclusion criteria (5 listed)
- Exfoliated primary molars
- Primary molars with internal resorption
- Primary molars with extensive tooth decay of the crown
- Primary molars with discoloration
- Cracked tooth
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 |
|---|---|---|
| Mineral Trioxide AggregateAlso: MTAMineral Trioxide Aggregate stimulates cementoblasts to produce matrix for cementum formation and is biocompatible with the periradicular tissues thus shows a superior sealing ability when used in perforation repair | Combination product | control group |
| BiodentineBiodentine has a good sealing ability, high compressive strengths, short setting time, biocompatibility, bioactivity and biomineralization properties that make it available to be used in endodontic repair procedures | Combination product | experimental group |
Primary outcome
sealing ability
Time frame: 24 hours
* measured by scanning electron microscope * Unit of measurement : µm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Tooth Injuries
RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
Alcohol Use Disorder
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
Not yet recruitingObservational study
Blood NfL and Functional Outcomes After Moderate-to-Severe TBI
Traumatic Brain Injury
Recruiting
Effect of Curcumin Topical Spray on Wound Healing After Tooth Extraction
Wound Healing, Alveolitis of Jaw
Active, not recruiting
Luting Cements for Prefabricated Zirconia Crown Retention in Primary Anterior Teeth in Children
Dental Caries, Tooth Injuries
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.
Questions about this trial
What is this clinical trial studying?
A study testing Mineral Trioxide Aggregate and Biodentine in people with Tooth Injuries, run by Amany hasanean Abd El sadek.
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 3 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: status not confirmed, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
sealing ability (time frame: 24 hours). 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 25 Aug 2021.