Pulp Disease, DentalNCT05981352
Evaluation of Different Materials in Pulpotomy of Primary Molars
A study testing mineral trioxide aggregate pulpotomy, Dehydrated amniotic membrane pulpotomy and Hyaluronic acid pulpotomy in people with Pulp Disease, Dental, run by Ain Shams University.
Trial summary
The aim of the current study is to evaluate and compare clinical and radiographic success and antibacterial effect of Hyaluronic Acid and Amniotic membrane pulpotomy in primary molars in comparison with MTA pulpotomy (Randomized Clinical Trial and In Vitro Study). Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Pulp Disease, Dental
- What is being tested?
- mineral trioxide aggregate pulpotomy, Dehydrated amniotic membrane pulpotomy and Hyaluronic acid pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to 1 Oct 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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients aged from 4 to 8 years old.
- Patients who are free from ant medical condition.
- Patients who have a vital deep carious Mandibular primary molar which is indicated for pulpotomy .
- No clinical signs or symptoms of irreversible pulpitis as pain on percussion, tooth mobility, presence of sinus or fistula, history of swelling , Spontaneous pain.
- No radiographic evidence of any periapical pathosis , Internal or external root resorption , Absence of discontinuity of lamina dura .
- Physiological root resorption not more than 1/3 of crown
Who cannot join
- Teeth that are badly broken down, that cannot be restored.
- Presence of uncontrolled bleeding after pulpotomy
- Patients/ parent guardians that refuse to sign informed consent.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical, Radiographic and Microbiological Evaluation of Hyaluronic Acid and Amniotic Membrane Allograft in Comparison to Mineral Trioxide Aggregate in Pulpotomy of Primary Molars (Randomized Clinical Trial and In Vitro Study)
The aim of the current study is to evaluate and compare clinical and radiographic success and antibacterial effect of Hyaluronic Acid and Amniotic membrane pulpotomy in primary molars in comparison with MTA pulpotomy (Randomized Clinical Trial and In Vitro Study).
Read the detailed description
Pulpotomy is one of the most used frequently treatment for pulp involved in primary teeth. Pulpotomy is performed in a primary tooth with extensive caries but without evidence of radicular pathology when caries removal results in a carious or mechanical pulp exposure. It is a conservative therapy performed to remove the inflamed coronal pulp tissues followed by application of an effective and compatible bactericidal medicament.
Many different compounds have been suggested include glutaraldehyde, electrosurgery, calcium hydroxide, ferric sulfate, freeze-dried bone, bone morphogenic proteins (BMP), mineral trioxide aggregate (MTA) and Bio dentine (Tricalcium Silicate Cement) as replacement for Form cresol in pulpotomy procedure however.
Pulpotomy has been broadly classified as devitalization, preservation, and regeneration of the remaining pulp tissue. Other materials that has shown immense potential for regeneration like mineral trioxide aggregate (MTA). It is a biocompatible and bio inductive material that has been investigated for endodontic.
Hyaluronic acid (HA) has recently emerged as a material of choice in preserving the vitality of the pulp. It is a natural mucopolysaccharide, carbohydrate polymer from the group of glycosaminoglycans. HA is synthetized on the cytoplasmic surface of plasma membranes and is common in humans and other vertebrates. It is the major component of the inner-cell cement of the capillary wall, and of the extracellular matrix of the connective tissue. Deposition of HA significantly increases during development, morphogenesis, wound repair and regeneration, malignancy, and inflammation.
Hyaluronic acid (HA) or hyaluronan is a hydrated anionic polysaccharide plentiful in the extracellular matrix with a molecular weight of 4000-20,000,000 Da that is found in a variety of tissues including skin, synovial fluid, cartilage, tendons, eyes and embryonic mesenchyme . It is comprised of repeating disaccharides d-glucuronic acid and N-acetyl-d-glucosamine, which are joined together by alternating β-1,4 and β-1,3 glycoside bonding. During bone repair, it encourages the undifferentiated mesenchymal cells to migrate, adhere, and proliferate into osteoblastic cells. Due to its non-toxicity, biocompatibility, biodegradability and non-immunogenicity, and used in ophthalmology and orthopedics as an anti-inflammatory agent and anti bacterial agent.
The use of a hyaluronic acid to cover a dentin defect, stimulated a cell-rich rearrangement of pulp tissue with few inflammatory cells, as well as being an acceptable and biocompatible scaffold for regenerating the dental pulp. Because of its high molecular weight when dissolved in water, hyaluronic acid's viscoelasticity increases, making it simpler to use as an injectable scaffold. Moreover, advantageous characteristics are related to the hyaluronic acid scaffolds as bioactivity, biocompatibility, biodegradability, in addition to serving as a reservoir for growth factors..
It is important to propose new biologically based therapeutics directed at preserving pulp vitality , forming biological tissue and neutralizing the side effects of previously used synthetically based biomaterials .
Recently, novel biologically based materials have been developed from the placenta or other gestational tissues like the umbilical cord with highly rich stem cell reservoirs . Amniotic membrane (AM) is a fetes membranous sac forming the innermost layer of the placenta. It is a bi-layered membrane consists of amnion and chorion. Amnion consists of 3 distinct thin layers: an epithelial monolayer (closest to the fetes),a basement membrane and avascular mesenchymal stromal matrix (containing mesenchymal stem cells) that composed of 3 adjacent but distinct layers: outermost spongy, middle fibroblastic and inner compact.
Although it is a thin membrane (70-180 μm thick), it is remarkably elastic and strong natural biological barricade protecting the fetus from trauma and bacterial infection . In contrast, the chorion is 3-4 times thicker than amnion and consists of a reticular, basement membrane, and trophoblastic layers. Both membranes play important roles in embryo's overall development, embryo's nourishment and breathing .
Amniotic membrane matrix contains plenteous growth factors (GFs) including basic-fibroblast growth factor (b-FGF), nidogen growth factor (NGF), keratinocyte growth factor (KGF), epidermal derived growth factor (EDGF), and transforming GF-beta growth factor (TGF-β) which promote tissue regeneration . These GFs mimic the stem cell niche for ex vivo growth and provide a natural healing environment. It acts as a structural scaffold supporting proliferation, differentiation, and regeneration due to presence of fibronectin, laminins, proteoglycans, collagen types I, III, IV, V and VI, elastin, nidogen, and hyaluronic acid in its stromal layer, and act as an excellent candidature for a native scaffold in tissue engineering .
Furthermore, it secretes nutrient factors , promotes cell migration, adhesion, differentiation, and suppresses the semi allogenic immune response against the foetus . In addition, it has a biological, anti-inflammatory (similar to cortisone and steroids shots), anti-fibrotic, anti-microbial (including beta-defensins), anti-scarring, anti-angiogenic and analgesic properties that make it a unique therapy for wound care and ideal substrate for supporting the growth of mesenchymal progenitor cells via prolonging their lifespan
It is used in allotransplant due to its ability to promote cellular growth and attachment with the lack of its immunogenicity and toxicity; it was first reported by Davis since 1910 in skin transplantation. Also, it has been used successfully for over a decade in a wide range of surgical application, biological wound dressing, ophthalmic reconstructive surgery, an adhesion barrier in the spine, and in-ear and orthopedic surgery. It is easily obtained, processed, transported, and prepared in different forms for clinical use like fresh, dried, frozen, freeze derived irradiated, stabilized amniotic and cryopreserved membranes .
Amnion-based products have a proven rate of success in the field of dentistry since 1990s, when first demonstrated safety and efficacy in pre-and clinical studies . The dehydrated or cryopreserved membrane is used for retaining the majority of the natural (fibrillar and membranous) collagens, maintaining the composition of GFs and bioactive molecules found in natural and unprocessed placental tissues, and increasing stability and shelf life of the product .
- Conditions
- Pulp Disease, Dental
- Being tested
- mineral trioxide aggregate pulpotomy, Dehydrated amniotic membrane pulpotomy, Hyaluronic acid pulpotomy
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mineral trioxide aggregate pulpotomyProcedure or surgery
- After achieving hemostats, Mineral trioxide aggregate powder will be mixed with saline.
- Then Mineral trioxide aggregate will be placed directly on the pulp stumps.
Dehydrated amniotic membrane pulpotomyProcedure or surgery
- After achieving haemostasis, a double layer of sterile processed human allograft tis¬sue (dehydrated dual-layer dental amni¬on patch) will be trimed and soaked in saline for a minute.
- Dehydrated amniotic membrane will be Placed directly on the pup stumps using sterile tweezers and adjust¬ed to the entire floor of the pulp chamber.
Hyaluronic acid pulpotomyProcedure or surgery
- After achieving haemostasis, pulp stumps will be covered with a mixture of Hyaluronic acid gel and zinc oxide powder with consistency (1:1 ratio by volume) .
- The cavities of all pulpotomy molars will be sealed with a layer of reinforced zinc oxide and eugenol .
| Study group | Role | What they receive |
|---|---|---|
| Mineral trioxide aggregate (positive control group) | Active comparator | : according to the manufacturing instructions as following:
* After achieving hemostasis, Mineral trioxide aggregate powder will be mixed with saline.
* Then Mineral trioxide aggregate will be placed directly on the pulp stumps. Receives: Procedure: mineral trioxide aggregate pulpotomy |
| Dehydrated amniotic membrane group | Experimental | * After achieving hemostasis, a double layer of sterile processed human allograft tissue (dehydrated dual-layer dental amnion patch) will be trimmed and soaked in saline for a minute.
* Dehydrated amniotic membrane will be Placed directly on the pup stumps using sterile tweezers and adjusted to the entire floor of the pulp chamber. Receives: Procedure: Dehydrated amniotic membrane pulpotomy |
| Hyaluronic acid group | Experimental | • After achieving hemostasis, pulp stumps will be covered with a mixture of Hyaluronic acid gel and zinc oxide powder with consistency (1:1 ratio by volume) . Receives: Procedure: Hyaluronic acid pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pulp testing
pulp testing clinically measured by zurn and seale criteria ,
Measured: 0 baseline , changes from baseline pulp condition at 3 month, change from the baseline pulp condition at 6 month, change from baseline pulp condition at 9 month, change from base line pulp condition at 12 month.
Radio graphic pulp testing
pulp testing radio graphic measured by digital radio graph parallel technique
Measured: 0 baseline , changes from baseline pulp condition at 3 month, change from the baseline pulp condition at 6 month, change from baseline pulp condition at 9 month, change from base line pulp condition at 12 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study startOct 2023 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp Disease, DentalStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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, Care provider
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- eman Ib Abdel Maksoud, doctor, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981352
- Sponsor's protocol ID
- Pulpotomy of Primary Molars
- Status last verified
- May 2023
- First submitted
- 26 Jan 2023
- Last updated
- 24 Aug 2023
- 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 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Radiographic and Microbiological Evaluation of Hyaluronic Acid and Amniotic Membrane Allograft in Comparison to Mineral Trioxide Aggregate in Pulpotomy of Primary Molars (Randomized Clinical Trial and In Vitro Study)
- ClinicalTrials.gov ID
- NCT05981352
- Acronym / sponsor ID
- Pulpotomy of Primary Molars
- Conditions
- Pulp Disease, Dental
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 8 Aug 2023 (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 aim of the current study is to evaluate and compare clinical and radiographic success and antibacterial effect of Hyaluronic Acid and Amniotic membrane pulpotomy in primary molars in comparison with MTA pulpotomy (Randomized Clinical Trial and In Vitro Study).
Detailed description
Pulpotomy is one of the most used frequently treatment for pulp involved in primary teeth. Pulpotomy is performed in a primary tooth with extensive caries but without evidence of radicular pathology when caries removal results in a carious or mechanical pulp exposure. It is a conservative therapy performed to remove the inflamed coronal pulp tissues followed by application of an effective and compatible bactericidal medicament.
Many different compounds have been suggested include glutaraldehyde, electrosurgery, calcium hydroxide, ferric sulfate, freeze-dried bone, bone morphogenic proteins (BMP), mineral trioxide aggregate (MTA) and Bio dentine (Tricalcium Silicate Cement) as replacement for Form cresol in pulpotomy procedure however.
Pulpotomy has been broadly classified as devitalization, preservation, and regeneration of the remaining pulp tissue. Other materials that has shown immense potential for regeneration like mineral trioxide aggregate (MTA). It is a biocompatible and bio inductive material that has been investigated for endodontic.
Hyaluronic acid (HA) has recently emerged as a material of choice in preserving the vitality of the pulp. It is a natural mucopolysaccharide, carbohydrate polymer from the group of glycosaminoglycans. HA is synthetized on the cytoplasmic surface of plasma membranes and is common in humans and other vertebrates. It is the major component of the inner-cell cement of the capillary wall, and of the extracellular matrix of the connective tissue. Deposition of HA significantly increases during development, morphogenesis, wound repair and regeneration, malignancy, and inflammation.
Hyaluronic acid (HA) or hyaluronan is a hydrated anionic polysaccharide plentiful in the extracellular matrix with a molecular weight of 4000-20,000,000 Da that is found in a variety of tissues including skin, synovial fluid, cartilage, tendons, eyes and embryonic mesenchyme . It is comprised of repeating disaccharides d-glucuronic acid and N-acetyl-d-glucosamine, which are joined together by alternating β-1,4 and β-1,3 glycoside bonding. During bone repair, it encourages the undifferentiated mesenchymal cells to migrate, adhere, and proliferate into osteoblastic cells. Due to its non-toxicity, biocompatibility, biodegradability and non-immunogenicity, and used in ophthalmology and orthopedics as an anti-inflammatory agent and anti bacterial agent.
The use of a hyaluronic acid to cover a dentin defect, stimulated a cell-rich rearrangement of pulp tissue with few inflammatory cells, as well as being an acceptable and biocompatible scaffold for regenerating the dental pulp. Because of its high molecular weight when dissolved in water, hyaluronic acid's viscoelasticity increases, making it simpler to use as an injectable scaffold. Moreover, advantageous characteristics are related to the hyaluronic acid scaffolds as bioactivity, biocompatibility, biodegradability, in addition to serving as a reservoir for growth factors..
It is important to propose new biologically based therapeutics directed at preserving pulp vitality , forming biological tissue and neutralizing the side effects of previously used synthetically based biomaterials .
Recently, novel biologically based materials have been developed from the placenta or other gestational tissues like the umbilical cord with highly rich stem cell reservoirs . Amniotic membrane (AM) is a fetes membranous sac forming the innermost layer of the placenta. It is a bi-layered membrane consists of amnion and chorion. Amnion consists of 3 distinct thin layers: an epithelial monolayer (closest to the fetes),a basement membrane and avascular mesenchymal stromal matrix (containing mesenchymal stem cells) that composed of 3 adjacent but distinct layers: outermost spongy, middle fibroblastic and inner compact.
Although it is a thin membrane (70-180 μm thick), it is remarkably elastic and strong natural biological barricade protecting the fetus from trauma and bacterial infection . In contrast, the chorion is 3-4 times thicker than amnion and consists of a reticular, basement membrane, and trophoblastic layers. Both membranes play important roles in embryo's overall development, embryo's nourishment and breathing .
Amniotic membrane matrix contains plenteous growth factors (GFs) including basic-fibroblast growth factor (b-FGF), nidogen growth factor (NGF), keratinocyte growth factor (KGF), epidermal derived growth factor (EDGF), and transforming GF-beta growth factor (TGF-β) which promote tissue regeneration . These GFs mimic the stem cell niche for ex vivo growth and provide a natural healing environment. It acts as a structural scaffold supporting proliferation, differentiation, and regeneration due to presence of fibronectin, laminins, proteoglycans, collagen types I, III, IV, V and VI, elastin, nidogen, and hyaluronic acid in its stromal layer, and act as an excellent candidature for a native scaffold in tissue engineering .
Furthermore, it secretes nutrient factors , promotes cell migration, adhesion, differentiation, and suppresses the semi allogenic immune response against the foetus . In addition, it has a biological, anti-inflammatory (similar to cortisone and steroids shots), anti-fibrotic, anti-microbial (including beta-defensins), anti-scarring, anti-angiogenic and analgesic properties that make it a unique therapy for wound care and ideal substrate for supporting the growth of mesenchymal progenitor cells via prolonging their lifespan
It is used in allotransplant due to its ability to promote cellular growth and attachment with the lack of its immunogenicity and toxicity; it was first reported by Davis since 1910 in skin transplantation. Also, it has been used successfully for over a decade in a wide range of surgical application, biological wound dressing, ophthalmic reconstructive surgery, an adhesion barrier in the spine, and in-ear and orthopedic surgery. It is easily obtained, processed, transported, and prepared in different forms for clinical use like fresh, dried, frozen, freeze derived irradiated, stabilized amniotic and cryopreserved membranes .
Amnion-based products have a proven rate of success in the field of dentistry since 1990s, when first demonstrated safety and efficacy in pre-and clinical studies . The dehydrated or cryopreserved membrane is used for retaining the majority of the natural (fibrillar and membranous) collagens, maintaining the composition of GFs and bioactive molecules found in natural and unprocessed placental tissues, and increasing stability and shelf life of the product .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mineral trioxide aggregate (positive control group) | Active comparator | Procedure: mineral trioxide aggregate pulpotomy: according to the manufacturing instructions as following: * After achieving hemostasis, Mineral trioxide aggregate powder will be mixed with saline. * Then Mineral trioxide aggregate will be placed directly on the pulp stumps. |
| Dehydrated amniotic membrane group | Experimental | Procedure: Dehydrated amniotic membrane pulpotomy* After achieving hemostasis, a double layer of sterile processed human allograft tissue (dehydrated dual-layer dental amnion patch) will be trimmed and soaked in saline for a minute. * Dehydrated amniotic membrane will be Placed directly on the pup stumps using sterile tweezers and adjusted to the entire floor of the pulp chamber. |
| Hyaluronic acid group | Experimental | Procedure: Hyaluronic acid pulpotomy• After achieving hemostasis, pulp stumps will be covered with a mixture of Hyaluronic acid gel and zinc oxide powder with consistency (1:1 ratio by volume) . |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Patients aged from 4 to 8 years old.
- Patients who are free from ant medical condition.
- Patients who have a vital deep carious Mandibular primary molar which is indicated for pulpotomy .
- No clinical signs or symptoms of irreversible pulpitis as pain on percussion, tooth mobility, presence of sinus or fistula, history of swelling , Spontaneous pain.
- No radiographic evidence of any periapical pathosis , Internal or external root resorption , Absence of discontinuity of lamina dura .
Key exclusion criteria (3 listed)
- Teeth that are badly broken down, that cannot be restored.
- Presence of uncontrolled bleeding after pulpotomy
- Patients/ parent guardians that refuse to sign informed consent.
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 aggregate pulpotomy* After achieving hemostats, Mineral trioxide aggregate powder will be mixed with saline. * Then Mineral trioxide aggregate will be placed directly on the pulp stumps. | Procedure or surgery | Mineral trioxide aggregate (positive control group) |
| Dehydrated amniotic membrane pulpotomy* After achieving haemostasis, a double layer of sterile processed human allograft tis¬sue (dehydrated dual-layer dental amni¬on patch) will be trimed and soaked in saline for a minute. * Dehydrated amniotic membrane will be Placed directly on the pup stumps using sterile tweezers and adjust¬ed to the entire floor of the pulp chamber. | Procedure or surgery | Dehydrated amniotic membrane group |
| Hyaluronic acid pulpotomy* After achieving haemostasis, pulp stumps will be covered with a mixture of Hyaluronic acid gel and zinc oxide powder with consistency (1:1 ratio by volume) . * The cavities of all pulpotomy molars will be sealed with a layer of reinforced zinc oxide and eugenol . | Procedure or surgery | Hyaluronic acid group |
Primary outcome
clinical pulp testing
Time frame: 0 baseline , changes from baseline pulp condition at 3 month, change from the baseline pulp condition at 6 month, change from baseline pulp condition at 9 month, change from base line pulp condition at 12 month.
pulp testing clinically measured by zurn and seale criteria ,
Radio graphic pulp testing
Time frame: 0 baseline , changes from baseline pulp condition at 3 month, change from the baseline pulp condition at 6 month, change from baseline pulp condition at 9 month, change from base line pulp condition at 12 month.
pulp testing radio graphic measured by digital radio graph parallel technique
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
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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.
eman Ib Abdel Maksoud, doctor study chair
Ain Shams University
Questions about this trial
What is this clinical trial studying?
A study testing mineral trioxide aggregate pulpotomy, Dehydrated amniotic membrane pulpotomy and Hyaluronic acid pulpotomy in people with Pulp Disease, Dental, run by Ain Shams University.
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 6 inclusion and 3 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 24 Aug 2023. 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?
Contact eman Ib Abdel Masoud, doctor (01555682322, eman.abdelmaksoud@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical pulp testing (time frame: 0 baseline , changes from baseline pulp condition at 3 month, change from the baseline pulp condition at 6 month, change from baseline pulp condition at 9 month, change from base line pulp condition at 12 month.). 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?
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 24 Aug 2023.