Drug EffectNCT05300152
Pulpotomy Medications in Primary Teeth
A study testing pulpotomy procedure and Histological evaluation, Immunohistochemistry Protocol for Fibronectin Antibody and Immunohistochemistry Protocol for Osteopontin Antibody in people with Drug Effect, run by Suez Canal University at 1 site in Egypt.
Trial summary
this study is aimed to evaluate and compare the pulp response to ACTIVA BioACTIVE Base/Liner and MTA as pulpotomy medication in primary teeth. Read more about this study
- Who is it for?
- Ages 7 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Effect
- What is being tested?
- pulpotomy procedure and Histological evaluation, Immunohistochemistry Protocol for Fibronectin Antibody and Immunohistochemistry Protocol for Osteopontin Antibody
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Oct 2022to 5 Aug 2024
- 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 7 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy \& cooperative child
- No history of spontaneous pain
- No pathologic tooth mobility
- Normal gingival and periodontal condition
- Absence of furcal/periapical radiolucency
Who cannot join
- Uncooperativeness of child and/or parents
- Unrestorable tooth
- history of spontaneous pain
- Percussion sensitivity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Evaluation of Pulpal Response to ACTIVA BioACTIVE Versus Mineral Trioxide Aggregate (MTA) As a Vital Pulpotomy Medications in Primary Teeth: an in Vivo Study
this study is aimed to evaluate and compare the pulp response to ACTIVA BioACTIVE Base/Liner and MTA as pulpotomy medication in primary teeth.
Read the detailed description
Pulpotomy is an endodontic technique that involves amputating the coronal pulp and covering the residual root pulp with a clinically effective pulp medicament that is bactericidal, capable of forming a biological barrier and allows the physiological root resorption until primary tooth exfoliation. In primary dentition, pulpotomy therapy is divided into three types based on the treatment goals: devitalization (mummification), preservation, and regeneration. Formocresol is the benchmark for pulpotomy treatment in primary teeth. Buckley first used it to treat nonvital permanent teeth in 1904, and it later became a common pulpotomy medication for primary teeth primarily because of its superior clinical success and simplicity of use . However, toxicity, mutagenicity, and carcinogenicity issues posed by the possible systemic spreading of FC molecules via the root canals raised concerns on its use ; as a result, a more biocompatible, nontoxic medication was required.
Biocompatible and bioactive materials containing calcium silicate have become increasingly common in paediatric dentistry in recent years because of their properties, which include stimulation of pulp cell regeneration, re - routing of the inflammatory response, and improving the healing ability of the remaining vital pulp . Mineral trioxide aggregate (MTA) was developed and implemented as a root-end filling at Loma Linda University in California, USA, in 1993; its physical and chemical properties were identified by Torabinejad et al ., in 1995. MTA is a chemical compound composed of tricalcium silicate, dicalcium silicate, tricalcium aluminate, calcium sulphate dehydrate, gypsum, and bismuth oxide . It hydrates to form a colloidal gel with a pH of 12.5, equivalent to that of calcium hydroxide . Moreover, it takes 3 to 4 hours to set with a compressive strength of 70 Mpa after setting, which is comparable to Intermediate Restorative Material (IRM) . MTA is a biocompatible substance that seals better than amalgam or zinc oxide eugenol (ZOE) [30-32] also, it retains pulp vitality and induces repair as it comes into contact with dental pulp or peri-radicular tissues. MTA has been thoroughly examined clinically and radiologically, as well as compared to other pulpotomy medicaments, and it has been reported that MTA should be considered the new gold standard for pulp-capping therapy. On the other hand, MTA has some drawbacks, including difficulty in manipulation, a long setting duration, a high cost, poor mechanical properties, poor adhesion to dental tissue and tooth staining .
Several recent calcium silicate-based materials have been developed in order to alleviate MTA's drawbacks. ACTIVA BioACTIVE Base/Liner, a BioACTIVE glass-incorporated light-curable pulp capping material, was recently introduced in 2014 as a "light-cured resin-modified calcium silicate" (RMCS) claiming composite's resilience, aesthetics, and physical properties, as well as improved calcium, phosphate, and fluoride release when compared to glass ionomer . It comprised of a diurethane and methacrylate-based monomer with a modified polyacrylic acid and polybutadiene-modified diurethane dimethacrylate as well as BioACTIVE glass as a filler . ACTIVA has three setting reactions: it cures with low intensity light for 20 seconds per layer and has both glass-ionomer (acid-base reaction) and composite self-cure setting reactions. The bioactivity of ACTIVA BioACTIVE products is dependent on a process in which the material reacts to pH cycles and actively participates in the release and recharging of considerable amounts of calcium, phosphate, and fluoride . Theses mineral components are concerned with promoting the development of mineralized hard tissue also, they promote the creation of a connective apatite layer and the development of a seal at the material-tooth interface .
- Conditions
- Drug Effect
- Being tested
- pulpotomy procedure and Histological evaluation, Immunohistochemistry Protocol for Fibronectin Antibody, Immunohistochemistry Protocol for Osteopontin Antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulpotomy procedure and Histological evaluationProcedure or surgery
Sixty primary teeth in thirty children aged 7-9 years selected from Outpatient dental clinic Pedodontic and Endodontic Departments, Suez Canal University. divided into group I includes 30 teeth treated with ACTIVA BioACTIVE Base/Liner and group II includes 30 teeth treated by MTA with standard pulpotomy procedure Patients will be recalled after 15 and 30-days . 15 teeth from group I and 15 teeth from group II will be extracted after 15 days then subjected to decalcification then15 teeth from group I and 15 teeth from group II will be extracted after 30 days \& subjected to decalcification procedure in 20% EDTA at 4 °C for approximately 5 weeks then embedded in paraffin. Serial sections will be cut at 5 µm thickness. Deparaffinize the sections by 2 changes of xylene for 10 minutes each. Stain in Harris hematoxylin solution for 8 minutes. mount with xylene based mounting medium for conventional histological assessment using light microscope
Immunohistochemistry Protocol for Fibronectin AntibodyDiagnostic test
- Deparaffinization/Rehydration
- Slides heated in an oven at 65C for 1 hour.
- De-paraffinization
- Antigen Retrieval
- Immersion of slides into staining dish containing Antigen Retrieval Solution.
- Placing the staining dish into rice cooker.
- When turned to warm, unplug cooker
- Allow to cool down for 20 min
- Staining
- Wash slides with TBST for 5 min on a shaker.
- Inactivate endogenous peroxidase by 3% hydrogen peroxide for 10 min.
- Block slides with blocking solution for 1 hour.
- Dilute primary antibody in blocking buffer
- Apply primary antibody to each section and incubate overnight in humidified chamber
- Wash slides three times with TBST
Immunohistochemistry Protocol for Osteopontin AntibodyDiagnostic test
will be carried out via avidin-biotin-peroxidase complex method using a VECTASTAIN ABC Kit . Sections will be deparaffinized by xylene and graded ethanol then treated with 20 µg/ml Proteinase K for 10 min. to prevent endogenous peroxidase activity, sections is incubated for 30 min in 0.3% H2O2/methanol then treated with 0.1% blocking serum albumin and incubated with primary antibody for 30 min. Rabbit polyclonal anti-osteopontin and goat polyclonal anti-RANKL will be used. dilution of primary antibodies used will be osteopontin (1 : 6000-8000). After being washed with phosphate-buffered saline several times, sections will be incubated with biotinylated IgG for 30 min and subsequently with streptavidin-horseradish peroxidase for 30 min. Following several washes with phosphate-buffered saline, 3,3'-diaminobenzidine substrate will be applied. As a negative control, non-immune serum will be used instead of primary antibody.
| Study group | Role | What they receive |
|---|---|---|
| ACTIVA BioACTIVE Base/Liner | Experimental | is a BioACTIVE glass-incorporated light-curable pulp capping material also known as light-cured resin-modified calcium silicate Receives: Procedure: pulpotomy procedure and Histological evaluation; Diagnostic Test: Immunohistochemistry Protocol for Fibronectin Antibody; Diagnostic Test: Immunohistochemistry Protocol for Osteopontin Antibody |
| Mineral trioxide aggregate (MTA) | Active comparator | is a bioactive materials containing calcium silicate Receives: Procedure: pulpotomy procedure and Histological evaluation; Diagnostic Test: Immunohistochemistry Protocol for Fibronectin Antibody; Diagnostic Test: Immunohistochemistry Protocol for Osteopontin Antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
the regenerative effect of ACTIVA BioACTIVE Base/Liner and MTA as pulpotomy medication in primary teeth
by assessment of reparative dentin formation in the histological sections of the tested teeth by detection of the presence of odontoblast cells (dentin forming- cells) and mineralized tissue between the capping material and the remaining pulp tissue.
Measured: 12 months
Secondary outcomes (1)
the reparative dentinogenesis process after application of ACTIVA BioACTIVE Base/Liner and MTA as pulpotomy medication in primary teeth
by assessment the molecular signalling (production of fibronectin \& osteopontin antibody) involved in cell differentiation during reparative dentinogenesis process using Immunohistochemistry
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start2 Oct 2022
- Primary completion12 Jul 2024
- Study completion5 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Drug EffectStudies 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
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, shaimaa shaban mohamed el-desouky, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300152
- Sponsor's protocol ID
- 398/2021
- Status last verified
- Nov 2024
- First submitted
- 9 Mar 2022
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: protocol \& conclusion
Publications
Holan G, Eidelman E, Fuks AB. Long-term evaluation of pulpotomy in primary molars using mineral trioxide aggregate or formocresol. Pediatr Dent. 2005 Mar-Apr;27(2):129-36.
PubMed 15926290Gandolfi MG, Siboni F, Prati C. Chemical-physical properties of TheraCal, a novel light-curable MTA-like material for pulp capping. Int Endod J. 2012 Jun;45(6):571-9. doi: 10.1111/j.1365-2591.2012.02013.x. Epub 2012 Mar 31.
PubMed 22469093Anthoney D, Zahid S, Khalid H, Khurshid Z, Shah AT, Chaudhry AA, Khan AS. Effectiveness of Thymoquinone and Fluoridated Bioactive Glass/Nano-Oxide Contained Dentifrices on Abrasion and Dentine Tubules Occlusion: An Ex Vivo Study. Eur J Dent. 2020 Feb;14(1):45-54. doi: 10.1055/s-0040-1703418. Epub 2020 Mar 13.
PubMed 32168531Avram DC, Pulver F. Pulpotomy medicaments for vital primary teeth. Surveys to determine use and attitudes in pediatric dental practice and in dental schools throughout the world. ASDC J Dent Child. 1989 Nov-Dec;56(6):426-34.
PubMed 2530256Omer SMM, Elsaied HAF, Alghonemy WY, El-Desouky SS. Histopathological and immunohistochemical characterization of pulp tissue reaction to ACTIVA BioACTIVE base/liner in primary teeth pulpotomy: a randomized clinical trial. BMC Oral Health. 2025 Jun 3;25(1):885. doi: 10.1186/s12903-025-06177-x.
PubMed 40457274
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Evaluation of Pulpal Response to ACTIVA BioACTIVE Versus Mineral Trioxide Aggregate (MTA) As a Vital Pulpotomy Medications in Primary Teeth: an in Vivo Study
- ClinicalTrials.gov ID
- NCT05300152
- Acronym / sponsor ID
- 398/2021
- Conditions
- Drug Effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 2 Oct 2022 (actual)
- Primary completion
- 12 Jul 2024 (actual)
- Study completion
- 5 Aug 2024 (actual)
- First posted
- 29 Mar 2022 (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.
this study is aimed to evaluate and compare the pulp response to ACTIVA BioACTIVE Base/Liner and MTA as pulpotomy medication in primary teeth.
Detailed description
Pulpotomy is an endodontic technique that involves amputating the coronal pulp and covering the residual root pulp with a clinically effective pulp medicament that is bactericidal, capable of forming a biological barrier and allows the physiological root resorption until primary tooth exfoliation. In primary dentition, pulpotomy therapy is divided into three types based on the treatment goals: devitalization (mummification), preservation, and regeneration. Formocresol is the benchmark for pulpotomy treatment in primary teeth. Buckley first used it to treat nonvital permanent teeth in 1904, and it later became a common pulpotomy medication for primary teeth primarily because of its superior clinical success and simplicity of use . However, toxicity, mutagenicity, and carcinogenicity issues posed by the possible systemic spreading of FC molecules via the root canals raised concerns on its use ; as a result, a more biocompatible, nontoxic medication was required.
Biocompatible and bioactive materials containing calcium silicate have become increasingly common in paediatric dentistry in recent years because of their properties, which include stimulation of pulp cell regeneration, re - routing of the inflammatory response, and improving the healing ability of the remaining vital pulp . Mineral trioxide aggregate (MTA) was developed and implemented as a root-end filling at Loma Linda University in California, USA, in 1993; its physical and chemical properties were identified by Torabinejad et al ., in 1995. MTA is a chemical compound composed of tricalcium silicate, dicalcium silicate, tricalcium aluminate, calcium sulphate dehydrate, gypsum, and bismuth oxide . It hydrates to form a colloidal gel with a pH of 12.5, equivalent to that of calcium hydroxide . Moreover, it takes 3 to 4 hours to set with a compressive strength of 70 Mpa after setting, which is comparable to Intermediate Restorative Material (IRM) . MTA is a biocompatible substance that seals better than amalgam or zinc oxide eugenol (ZOE) [30-32] also, it retains pulp vitality and induces repair as it comes into contact with dental pulp or peri-radicular tissues. MTA has been thoroughly examined clinically and radiologically, as well as compared to other pulpotomy medicaments, and it has been reported that MTA should be considered the new gold standard for pulp-capping therapy. On the other hand, MTA has some drawbacks, including difficulty in manipulation, a long setting duration, a high cost, poor mechanical properties, poor adhesion to dental tissue and tooth staining .
Several recent calcium silicate-based materials have been developed in order to alleviate MTA's drawbacks. ACTIVA BioACTIVE Base/Liner, a BioACTIVE glass-incorporated light-curable pulp capping material, was recently introduced in 2014 as a "light-cured resin-modified calcium silicate" (RMCS) claiming composite's resilience, aesthetics, and physical properties, as well as improved calcium, phosphate, and fluoride release when compared to glass ionomer . It comprised of a diurethane and methacrylate-based monomer with a modified polyacrylic acid and polybutadiene-modified diurethane dimethacrylate as well as BioACTIVE glass as a filler . ACTIVA has three setting reactions: it cures with low intensity light for 20 seconds per layer and has both glass-ionomer (acid-base reaction) and composite self-cure setting reactions. The bioactivity of ACTIVA BioACTIVE products is dependent on a process in which the material reacts to pH cycles and actively participates in the release and recharging of considerable amounts of calcium, phosphate, and fluoride . Theses mineral components are concerned with promoting the development of mineralized hard tissue also, they promote the creation of a connective apatite layer and the development of a seal at the material-tooth interface .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACTIVA BioACTIVE Base/Liner | Experimental | Procedure: pulpotomy procedure and Histological evaluation, Diagnostic Test: Immunohistochemistry Protocol for Fibronectin Antibody, Diagnostic Test: Immunohistochemistry Protocol for Osteopontin Antibodyis a BioACTIVE glass-incorporated light-curable pulp capping material also known as light-cured resin-modified calcium silicate |
| Mineral trioxide aggregate (MTA) | Active comparator | Procedure: pulpotomy procedure and Histological evaluation, Diagnostic Test: Immunohistochemistry Protocol for Fibronectin Antibody, Diagnostic Test: Immunohistochemistry Protocol for Osteopontin Antibodyis a bioactive materials containing calcium silicate |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy \& cooperative child
- No history of spontaneous pain
- No pathologic tooth mobility
- Normal gingival and periodontal condition
- Absence of furcal/periapical radiolucency
Key exclusion criteria (4 listed)
- Uncooperativeness of child and/or parents
- Unrestorable tooth
- history of spontaneous pain
- Percussion sensitivity
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 |
|---|---|---|
| pulpotomy procedure and Histological evaluationSixty primary teeth in thirty children aged 7-9 years selected from Outpatient dental clinic Pedodontic and Endodontic Departments, Suez Canal University. divided into group I includes 30 teeth treated with ACTIVA BioACTIVE Base/Liner and group II includes 30 teeth treated by MTA with standard pulpotomy procedure Patients will be recalled after 15 and 30-days . 15 teeth from group I and 15 teeth from group II will be extracted after 15 days then subjected to decalcification then15 teeth from group I and 15 teeth from group II will be extracted after 30 days \& subjected to decalcification procedure in 20% EDTA at 4 °C for approximately 5 weeks then embedded in paraffin. Serial sections will be cut at 5 µm thickness. Deparaffinize the sections by 2 changes of xylene for 10 minutes each. Stain in Harris hematoxylin solution for 8 minutes. mount with xylene based mounting medium for conventional histological assessment using light microscope | Procedure or surgery | ACTIVA BioACTIVE Base/Liner, Mineral trioxide aggregate (MTA) |
| Immunohistochemistry Protocol for Fibronectin Antibody1. Deparaffinization/Rehydration * Slides heated in an oven at 65C for 1 hour. * De-paraffinization 2. Antigen Retrieval * Immersion of slides into staining dish containing Antigen Retrieval Solution. * Placing the staining dish into rice cooker. * When turned to warm, unplug cooker * Allow to cool down for 20 min 3. Staining * Wash slides with TBST for 5 min on a shaker. * Inactivate endogenous peroxidase by 3% hydrogen peroxide for 10 min. * Block slides with blocking solution for 1 hour. * Dilute primary antibody in blocking buffer * Apply primary antibody to each section and incubate overnight in humidified chamber * Wash slides three times with TBST | Diagnostic test | ACTIVA BioACTIVE Base/Liner, Mineral trioxide aggregate (MTA) |
| Immunohistochemistry Protocol for Osteopontin Antibodywill be carried out via avidin-biotin-peroxidase complex method using a VECTASTAIN ABC Kit . Sections will be deparaffinized by xylene and graded ethanol then treated with 20 µg/ml Proteinase K for 10 min. to prevent endogenous peroxidase activity, sections is incubated for 30 min in 0.3% H2O2/methanol then treated with 0.1% blocking serum albumin and incubated with primary antibody for 30 min. Rabbit polyclonal anti-osteopontin and goat polyclonal anti-RANKL will be used. dilution of primary antibodies used will be osteopontin (1 : 6000-8000). After being washed with phosphate-buffered saline several times, sections will be incubated with biotinylated IgG for 30 min and subsequently with streptavidin-horseradish peroxidase for 30 min. Following several washes with phosphate-buffered saline, 3,3'-diaminobenzidine substrate will be applied. As a negative control, non-immune serum will be used instead of primary antibody. | Diagnostic test | ACTIVA BioACTIVE Base/Liner, Mineral trioxide aggregate (MTA) |
Primary outcome
the regenerative effect of ACTIVA BioACTIVE Base/Liner and MTA as pulpotomy medication in primary teeth
Time frame: 12 months
by assessment of reparative dentin formation in the histological sections of the tested teeth by detection of the presence of odontoblast cells (dentin forming- cells) and mineralized tissue between the capping material and the remaining pulp tissue.
1 secondary outcome
the reparative dentinogenesis process after application of ACTIVA BioACTIVE Base/Liner and MTA as pulpotomy medication in primary teeth
Time frame: 12 months
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 29 Nov 2024.
- Background: PubMed 15926290Holan G, Eidelman E, Fuks AB. Long-term evaluation of pulpotomy in primary molars using mineral trioxide aggregate or formocresol. Pediatr Dent. 2005 Mar-Apr;27(2):129-36.
- Background: PubMed 22469093Gandolfi MG, Siboni F, Prati C. Chemical-physical properties of TheraCal, a novel light-curable MTA-like material for pulp capping. Int Endod J. 2012 Jun;45(6):571-9. doi: 10.1111/j.1365-2591.2012.02013.x. Epub 2012 Mar 31.
- Background: PubMed 32168531Anthoney D, Zahid S, Khalid H, Khurshid Z, Shah AT, Chaudhry AA, Khan AS. Effectiveness of Thymoquinone and Fluoridated Bioactive Glass/Nano-Oxide Contained Dentifrices on Abrasion and Dentine Tubules Occlusion: An Ex Vivo Study. Eur J Dent. 2020 Feb;14(1):45-54. doi: 10.1055/s-0040-1703418. Epub 2020 Mar 13.
- Background: PubMed 2530256Avram DC, Pulver F. Pulpotomy medicaments for vital primary teeth. Surveys to determine use and attitudes in pediatric dental practice and in dental schools throughout the world. ASDC J Dent Child. 1989 Nov-Dec;56(6):426-34.
- Derived from this study: PubMed 40457274Omer SMM, Elsaied HAF, Alghonemy WY, El-Desouky SS. Histopathological and immunohistochemical characterization of pulp tissue reaction to ACTIVA BioACTIVE base/liner in primary teeth pulpotomy: a randomized clinical trial. BMC Oral Health. 2025 Jun 3;25(1):885. doi: 10.1186/s12903-025-06177-x.
- Individual participant dataSharing planned: Yes. protocol \& conclusion
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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 pulpotomy procedure and Histological evaluation, Immunohistochemistry Protocol for Fibronectin Antibody and Immunohistochemistry Protocol for Osteopontin Antibody in people with Drug Effect, run by Suez Canal 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 5 inclusion and 4 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 29 Nov 2024. 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?
the regenerative effect of ACTIVA BioACTIVE Base/Liner and MTA as pulpotomy medication in primary teeth (time frame: 12 months). 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 NCT05300152, which also lists 5 linked publications.
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 29 Nov 2024.