Pulpotomies Primary TeethPhase 1HA - MTANCT06611631
Clinical and Radiographic Evaluation of Hyaluronic Acid (Gengigel Teething) Versus Mineral Trioxide Aggregate( Angelus) as Pulpotomy Agent in Vital Primary Molars
A Phase 1 study testing Hyaluronic acid pulpotomy and mineral trioxide aggregate pulpotomy in people with Pulpotomies Primary Teeth and Pulp Disease, Dental, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to Clinical and Radiographic Evaluation of Hyaluronic Acid (Gengigel Teething) Versus Mineral Trioxide Aggregate( Angelus) as Pulpotomy Agent in Vital Primary Molars. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Pulpotomies Primary Teeth, Pulp Disease, Dental
- What is being tested?
- Hyaluronic acid pulpotomy and mineral trioxide aggregate pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2025to Apr 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 4-8 years, in good general health and medically within normal.
- Teeth:
- Restorable mandibular primary molars.
- History of reversible pulpitis.
- Pre-operative Radiographic criteria:
Show all 9Show fewer
- Absence of periapical or inter-radicular radiolucencies.
- Absence of widening of periodontal ligaments (PDL) space.
- Absence of internal or external root resorption.
Who cannot join
- Patients:
- With systemic disorders.
- Physical or mental disabilities.
- Unable to attend follow- up visits.
- Refusal of Participation.
- Refusal to sign the informed consent.
Show all 11Show fewer
- Teeth:
- Previously accessed teeth.
- Mobile mandibular primary molars.
- Swelling in the vestibule or on palpation.
- Pain on percussion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
yasmin mohammed yossury, Ass.Prof contact
About this study
Official title: Clinical and Radiographic Evaluation of Hyaluronic Acid (Gengigel Teething) Versus Mineral Trioxide Aggregate( Angelus) as Pulpotomy Agent in Vital Primary Molars: A Randomized Clinical Trial
The goal of this clinical trial is to Clinical and Radiographic Evaluation of Hyaluronic Acid (Gengigel Teething) Versus Mineral Trioxide Aggregate( Angelus) as Pulpotomy Agent in Vital Primary Molars.
The main question it aims to answer is:
Is there a difference in the clinical or radiographic success when using Hyaluronic acid (Gengigel Teething, Ricerfarma , Italy) versus mineral trioxide aggregate (Angelus, Londrina ,Brazil) in pulpotomy of carious primary molars in children?
Read the detailed description
Preservation of primary dentition decreases the risk of developing any occlusal abnormalities caused by premature loss of primary teeth, which are considered natural space maintainers for the successor permanent teeth, therefore vital pulp therapy is of a big concern in the research field in pediatric dentistry.
One of the most commonly used regenerative materials in pulpotomies is Mineral Trioxide Aggregate (MTA) which showed a high success rate clinically and radiographically when compared to other materials due to its biocompatibility, antibacterial properties and excellent sealing ability . However it has some drawbacks such as difficult manipulation and handling because it is supplied in powder and liquid form which need mixing. Mixing is operator dependent and may be not uniform if handled wrongly, technique sensitive, potential discoloration, and long setting time.
Hyaluronic acid have been introduced as a new biologically based therapeutics directed at preserving pulp vitality. Owing to good handling characteristics, biocompatibility, odontogenic property. non-toxic, biodegradable ,non-immunogenic , anti-inflammatory and antibacterial action, hyaluronic acid is a promising pulpotomy agent Furthermore, the use of a gel containing HA facilitated faster healing in laser-induced wounds by secondary intention. HA tends to be helpful in the treatment of swelling and trismus as well as the inflammatory reaction after third molar extraction.
The benefits of this study to the participants:
A cheaper , faster and easier clinical procedure leads to a more efficient dental treatment, which could develop positive attitude of children towards dentistry.
The benefits of this study to the population:
- Providing better quality of dental treatment.
- Enhance the overall oral health of children.
The benefits of this study to the clinicians:
- Providing a new biological and alternative treatment option.
- Decreased chairside time owing to its better manipulation and less technique sensitive .
- cheaper and accessible alternative .
- Conditions
- Pulpotomies Primary Teeth, Pulp Disease, Dental
- Being tested
- Hyaluronic acid pulpotomy, mineral trioxide aggregate pulpotomy
- Keywords
- hyaluronic acid, HA, MTA, Mineral Trioxide Aggregate
- 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.
Hyaluronic acid pulpotomyProcedure or surgery
Also called HA pulpotomy
- After complete hemostasis, pulp stumps will be covered with a mixture of Hyaluronic acid gel and zinc oxide powder to reach suitable consistency (1:1 ratio by volume) then gentle condensation in the pulp chamber will be done by a moistened cotton pellet and then the rest of the pulp chamber will be filled by glass ionomer restoration .
- Tooth will be restored with stainless steel crown.
mineral trioxide aggregate pulpotomyProcedure or surgery
Also called MTA pulpotomy
- After complete hemostasis, MTA+ saline will be manipulated in the ratio of 3:1 (powder: liquid) to obtain a putty mix. This mix will be placed over the radicular pulp with the help of a suitable sterile amalgam carrier. Gentle condensation of the mix will be done in the pulp chamber with a moistened cotton pellet, followed by the application of glass ionomer restoration.
- Tooth will then be restored with stainless steel crown.
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic Acid Pulpotmoy | Experimental | 1. After complete hemostasis, pulp stumps will be covered with a mixture of Hyaluronic acid gel and zinc oxide powder to reach suitable consistency (1:1 ratio by volume) then gentle condensation in the pulp chamber will be done by a moistened cotton pellet and then the rest of the pulp chamber will be filled by glass ionomer restoration .
2. Tooth will be restored with stainless steel crown. Receives: Procedure: Hyaluronic acid pulpotomy |
| Mineral Trioxide Aggregate | Active comparator | 1. After complete hemostasis, MTA+ saline will be manipulated in the ratio of 3:1 (powder: liquid) to obtain a putty mix. This mix will be placed over the radicular pulp with the help of a suitable sterile amalgam carrier. Gentle condensation of the mix will be done in the pulp chamber with a moistened cotton pellet, followed by the application of glass ionomer restoration.
2. Tooth will then be restored with stainless steel crown. Receives: Procedure: mineral trioxide aggregate pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of post- operative pain.
Asking the patient and/or guardian. Outcome measuring unit :Binary (present/absent)
Measured: 1 week changes from baseline pulp condition
Absence of pain on percussion.
Percussion test using the back of a dental mirror. Outcome measuring unit :Binary (present/absent)
Measured: 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.
Absence of Swelling.
Visual examination. Outcome measuring unit :Binary (present/absent)
Measured: 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.
Absence of Sinus or fistula.
Visual examination. Outcome measuring unit :Binary (present/absent)
Measured: 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.
Pathologic mobility
Mobility test (pressure using the end of two dental mirrors). Outcome measuring unit :Binary (present/absent)
Measured: 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.
Secondary outcomes (3)
Absence of external or internal root resorption.
Intraoral digital periapical X-ray. Outcome measuring unit :Binary (present/absent)
Measured: at 3 month, change from the baseline pulp condition at 6 month, change from base line pulp condition at 12 month.
Absence of furcation or periapical radiolucency.
Intraoral digital periapical X-ray. Outcome measuring unit :Binary (present/absent)
Measured: at 3 month, change from the baseline pulp condition at 6 month, change from base line pulp condition at 12 month.
Absence of any adverse radiographic finding.
Intraoral digital periapical X-ray. Outcome measuring unit :Binary (present/absent)
Measured: at 3 month, change from the baseline pulp condition at 6 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 posted25 Sep 2024
- Study startMar 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Pulpotomies Primary TeethStudies of the same condition, open and under way.
- More trials run by Cairo 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadeer Nasser Hammad Aboeldahb, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611631
- Sponsor's protocol ID
- HA Pulpotomy
- Acronym
- HA - MTA
- Status last verified
- Nov 2024
- First submitted
- 22 Sep 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smail-Faugeron V, Fron Chabouis H, Durieux P, Attal JP, Muller-Bolla M, Courson F. Development of a core set of outcomes for randomized controlled trials with multiple outcomes--example of pulp treatments of primary teeth for extensive decay in children. PLoS One. 2013;8(1):e51908. doi: 10.1371/journal.pone.0051908. Epub 2013 Jan 3.
PubMed 23300955Chan AW, Pello A, Kitchen J, Axentiev A, Virtanen JI, Liu A, Hemminki E. Association of Trial Registration With Reporting of Primary Outcomes in Protocols and Publications. JAMA. 2017 Nov 7;318(17):1709-1711. doi: 10.1001/jama.2017.13001.
PubMed 28892118Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.3 (updated February 2022). Cochrane, 2022.
Camilleri J. Hydration characteristics of Biodentine and Theracal used as pulp capping materials. Dent Mater. 2014 Jul;30(7):709-15. doi: 10.1016/j.dental.2014.03.012. Epub 2014 Apr 29.
PubMed 24793199Al-Johany SS, Al Amri MD, Alsaeed S, Alalola B. Dental Implant Length and Diameter: A Proposed Classification Scheme. J Prosthodont. 2017 Apr;26(3):252-260. doi: 10.1111/jopr.12517. Epub 2016 Jul 5.
PubMed 27379723Xu X, Jha AK, Duncan RL, Jia X. Heparin-decorated, hyaluronic acid-based hydrogel particles for the controlled release of bone morphogenetic protein 2. Acta Biomater. 2011 Aug;7(8):3050-9. doi: 10.1016/j.actbio.2011.04.018. Epub 2011 Apr 24.
PubMed 21550426Cowman MK, Lee HG, Schwertfeger KL, McCarthy JB, Turley EA. The Content and Size of Hyaluronan in Biological Fluids and Tissues. Front Immunol. 2015 Jun 2;6:261. doi: 10.3389/fimmu.2015.00261. eCollection 2015.
PubMed 26082778Koray M, Ofluoglu D, Onal EA, Ozgul M, Ersev H, Yaltirik M, Tanyeri H. Efficacy of hyaluronic acid spray on swelling, pain, and trismus after surgical extraction of impacted mandibular third molars. Int J Oral Maxillofac Surg. 2014 Nov;43(11):1399-403. doi: 10.1016/j.ijom.2014.05.003. Epub 2014 Jun 10.
PubMed 24924267Romeo U, Libotte F, Palaia G, Galanakis A, Gaimari G, Tenore G, Del Vecchio A, Polimeni A. Oral soft tissue wound healing after laser surgery with or without a pool of amino acids and sodium hyaluronate: a randomized clinical study. Photomed Laser Surg. 2014 Jan;32(1):10-6. doi: 10.1089/pho.2013.3509. Epub 2013 Dec 14.
PubMed 24328847Bagio DA, Lestari NA, Putra WA, Alinda SD, Ricardo S, Julianto I. The effect of hyaluronic acid conditioned media on hDPSCs differentiation through CD44 and transforming growth factor-beta1 expressions. J Adv Pharm Technol Res. 2023 Apr-Jun;14(2):89-93. doi: 10.4103/japtr.japtr_649_22. Epub 2023 Apr 13.
PubMed 37255878Motwani N, Ikhar A, Nikhade P, Chandak M, Rathi S, Dugar M, Rajnekar R. Premixed bioceramics: A novel pulp capping agent. J Conserv Dent. 2021 Mar-Apr;24(2):124-129. doi: 10.4103/JCD.JCD_202_20. Epub 2021 Oct 9.
PubMed 34759576Cordell S, Kratunova E, Marion I, Alrayyes S, Alapati SB. A Randomized Controlled Trial Comparing the Success of Mineral Trioxide Aggregate and Ferric Sulfate as Pulpotomy Medicaments for Primary Molars. J Dent Child (Chic). 2021 May 15;88(2):120-128.
PubMed 34321144Igna A. Vital Pulp Therapy in Primary Dentition: Pulpotomy-A 100-Year Challenge. Children (Basel). 2021 Sep 24;8(10):841. doi: 10.3390/children8100841.
PubMed 34682106Guagnano R, Romano F, Defabianis P. Evaluation of Biodentine in Pulpotomies of Primary Teeth with Different Stages of Root Resorption Using a Novel Composite Outcome Score. Materials (Basel). 2021 Apr 24;14(9):2179. doi: 10.3390/ma14092179.
PubMed 33923152
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Hyaluronic Acid (Gengigel Teething) Versus Mineral Trioxide Aggregate( Angelus) as Pulpotomy Agent in Vital Primary Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06611631
- Acronym / sponsor ID
- HA - MTA / HA Pulpotomy
- Conditions
- Pulpotomies Primary Teeth, Pulp Disease, Dental
- Keywords
- hyaluronic acid, HA, MTA, Mineral Trioxide Aggregate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 25 Sep 2024 (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 goal of this clinical trial is to Clinical and Radiographic Evaluation of Hyaluronic Acid (Gengigel Teething) Versus Mineral Trioxide Aggregate( Angelus) as Pulpotomy Agent in Vital Primary Molars.
The main question it aims to answer is:
Is there a difference in the clinical or radiographic success when using Hyaluronic acid (Gengigel Teething, Ricerfarma , Italy) versus mineral trioxide aggregate (Angelus, Londrina ,Brazil) in pulpotomy of carious primary molars in children?
Detailed description
Preservation of primary dentition decreases the risk of developing any occlusal abnormalities caused by premature loss of primary teeth, which are considered natural space maintainers for the successor permanent teeth, therefore vital pulp therapy is of a big concern in the research field in pediatric dentistry.
One of the most commonly used regenerative materials in pulpotomies is Mineral Trioxide Aggregate (MTA) which showed a high success rate clinically and radiographically when compared to other materials due to its biocompatibility, antibacterial properties and excellent sealing ability . However it has some drawbacks such as difficult manipulation and handling because it is supplied in powder and liquid form which need mixing. Mixing is operator dependent and may be not uniform if handled wrongly, technique sensitive, potential discoloration, and long setting time.
Hyaluronic acid have been introduced as a new biologically based therapeutics directed at preserving pulp vitality. Owing to good handling characteristics, biocompatibility, odontogenic property. non-toxic, biodegradable ,non-immunogenic , anti-inflammatory and antibacterial action, hyaluronic acid is a promising pulpotomy agent Furthermore, the use of a gel containing HA facilitated faster healing in laser-induced wounds by secondary intention. HA tends to be helpful in the treatment of swelling and trismus as well as the inflammatory reaction after third molar extraction.
The benefits of this study to the participants:
A cheaper , faster and easier clinical procedure leads to a more efficient dental treatment, which could develop positive attitude of children towards dentistry.
The benefits of this study to the population:
- Providing better quality of dental treatment.
- Enhance the overall oral health of children.
The benefits of this study to the clinicians:
- Providing a new biological and alternative treatment option.
- Decreased chairside time owing to its better manipulation and less technique sensitive .
- cheaper and accessible alternative .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic Acid Pulpotmoy | Experimental | Procedure: Hyaluronic acid pulpotomy1. After complete hemostasis, pulp stumps will be covered with a mixture of Hyaluronic acid gel and zinc oxide powder to reach suitable consistency (1:1 ratio by volume) then gentle condensation in the pulp chamber will be done by a moistened cotton pellet and then the rest of the pulp chamber will be filled by glass ionomer restoration . 2. Tooth will be restored with stainless steel crown. |
| Mineral Trioxide Aggregate | Active comparator | Procedure: mineral trioxide aggregate pulpotomy1. After complete hemostasis, MTA+ saline will be manipulated in the ratio of 3:1 (powder: liquid) to obtain a putty mix. This mix will be placed over the radicular pulp with the help of a suitable sterile amalgam carrier. Gentle condensation of the mix will be done in the pulp chamber with a moistened cotton pellet, followed by the application of glass ionomer restoration. 2. Tooth will then be restored with stainless steel crown. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Patients:
- Aged 4-8 years, in good general health and medically within normal.
- Restorable mandibular primary molars.
- History of reversible pulpitis.
- Absence of periapical or inter-radicular radiolucencies.
Key exclusion criteria (11 listed)
- With systemic disorders.
- Physical or mental disabilities.
- Unable to attend follow- up visits.
- Refusal of Participation.
- Refusal to sign the 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 |
|---|---|---|
| Hyaluronic acid pulpotomyAlso: HA pulpotomy1. After complete hemostasis, pulp stumps will be covered with a mixture of Hyaluronic acid gel and zinc oxide powder to reach suitable consistency (1:1 ratio by volume) then gentle condensation in the pulp chamber will be done by a moistened cotton pellet and then the rest of the pulp chamber will be filled by glass ionomer restoration . 2. Tooth will be restored with stainless steel crown. | Procedure or surgery | Hyaluronic Acid Pulpotmoy |
| mineral trioxide aggregate pulpotomyAlso: MTA pulpotomy1. After complete hemostasis, MTA+ saline will be manipulated in the ratio of 3:1 (powder: liquid) to obtain a putty mix. This mix will be placed over the radicular pulp with the help of a suitable sterile amalgam carrier. Gentle condensation of the mix will be done in the pulp chamber with a moistened cotton pellet, followed by the application of glass ionomer restoration. 2. Tooth will then be restored with stainless steel crown. | Procedure or surgery | Mineral Trioxide Aggregate |
Primary outcome
Absence of post- operative pain.
Time frame: 1 week changes from baseline pulp condition
Asking the patient and/or guardian. Outcome measuring unit :Binary (present/absent)
Absence of pain on percussion.
Time frame: 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.
Percussion test using the back of a dental mirror. Outcome measuring unit :Binary (present/absent)
Absence of Swelling.
Time frame: 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.
Visual examination. Outcome measuring unit :Binary (present/absent)
Absence of Sinus or fistula.
Time frame: 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.
Visual examination. Outcome measuring unit :Binary (present/absent)
Pathologic mobility
Time frame: 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.
Mobility test (pressure using the end of two dental mirrors). Outcome measuring unit :Binary (present/absent)
3 secondary outcomes
Absence of external or internal root resorption.
Time frame: at 3 month, change from the baseline pulp condition at 6 month, change from base line pulp condition at 12 month.
Absence of furcation or periapical radiolucency.
Time frame: at 3 month, change from the baseline pulp condition at 6 month, change from base line pulp condition at 12 month.
Absence of any adverse radiographic finding.
Time frame: at 3 month, change from the baseline pulp condition at 6 month, change from base line pulp condition at 12 month.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Background: PubMed 23300955Smail-Faugeron V, Fron Chabouis H, Durieux P, Attal JP, Muller-Bolla M, Courson F. Development of a core set of outcomes for randomized controlled trials with multiple outcomes--example of pulp treatments of primary teeth for extensive decay in children. PLoS One. 2013;8(1):e51908. doi: 10.1371/journal.pone.0051908. Epub 2013 Jan 3.
- Background: PubMed 28892118Chan AW, Pello A, Kitchen J, Axentiev A, Virtanen JI, Liu A, Hemminki E. Association of Trial Registration With Reporting of Primary Outcomes in Protocols and Publications. JAMA. 2017 Nov 7;318(17):1709-1711. doi: 10.1001/jama.2017.13001.
- BackgroundHiggins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.3 (updated February 2022). Cochrane, 2022.
- Background: PubMed 24793199Camilleri J. Hydration characteristics of Biodentine and Theracal used as pulp capping materials. Dent Mater. 2014 Jul;30(7):709-15. doi: 10.1016/j.dental.2014.03.012. Epub 2014 Apr 29.
- Background: PubMed 27379723Al-Johany SS, Al Amri MD, Alsaeed S, Alalola B. Dental Implant Length and Diameter: A Proposed Classification Scheme. J Prosthodont. 2017 Apr;26(3):252-260. doi: 10.1111/jopr.12517. Epub 2016 Jul 5.
- Background: PubMed 21550426Xu X, Jha AK, Duncan RL, Jia X. Heparin-decorated, hyaluronic acid-based hydrogel particles for the controlled release of bone morphogenetic protein 2. Acta Biomater. 2011 Aug;7(8):3050-9. doi: 10.1016/j.actbio.2011.04.018. Epub 2011 Apr 24.
- Background: PubMed 26082778Cowman MK, Lee HG, Schwertfeger KL, McCarthy JB, Turley EA. The Content and Size of Hyaluronan in Biological Fluids and Tissues. Front Immunol. 2015 Jun 2;6:261. doi: 10.3389/fimmu.2015.00261. eCollection 2015.
- Background: PubMed 24924267Koray M, Ofluoglu D, Onal EA, Ozgul M, Ersev H, Yaltirik M, Tanyeri H. Efficacy of hyaluronic acid spray on swelling, pain, and trismus after surgical extraction of impacted mandibular third molars. Int J Oral Maxillofac Surg. 2014 Nov;43(11):1399-403. doi: 10.1016/j.ijom.2014.05.003. Epub 2014 Jun 10.
- Background: PubMed 24328847Romeo U, Libotte F, Palaia G, Galanakis A, Gaimari G, Tenore G, Del Vecchio A, Polimeni A. Oral soft tissue wound healing after laser surgery with or without a pool of amino acids and sodium hyaluronate: a randomized clinical study. Photomed Laser Surg. 2014 Jan;32(1):10-6. doi: 10.1089/pho.2013.3509. Epub 2013 Dec 14.
- Background: PubMed 37255878Bagio DA, Lestari NA, Putra WA, Alinda SD, Ricardo S, Julianto I. The effect of hyaluronic acid conditioned media on hDPSCs differentiation through CD44 and transforming growth factor-beta1 expressions. J Adv Pharm Technol Res. 2023 Apr-Jun;14(2):89-93. doi: 10.4103/japtr.japtr_649_22. Epub 2023 Apr 13.
- Background: PubMed 34759576Motwani N, Ikhar A, Nikhade P, Chandak M, Rathi S, Dugar M, Rajnekar R. Premixed bioceramics: A novel pulp capping agent. J Conserv Dent. 2021 Mar-Apr;24(2):124-129. doi: 10.4103/JCD.JCD_202_20. Epub 2021 Oct 9.
- Background: PubMed 34321144Cordell S, Kratunova E, Marion I, Alrayyes S, Alapati SB. A Randomized Controlled Trial Comparing the Success of Mineral Trioxide Aggregate and Ferric Sulfate as Pulpotomy Medicaments for Primary Molars. J Dent Child (Chic). 2021 May 15;88(2):120-128.
- Individual participant dataSharing planned: No
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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.
yasmin mohammed yossury, Ass.Prof contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hyaluronic acid pulpotomy and mineral trioxide aggregate pulpotomy in people with Pulpotomies Primary Teeth and Pulp Disease, Dental, run by Cairo 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 9 inclusion and 11 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: opening soon, as of the sponsor's last update on 4 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hadeer Nasser Aboeldahb, Doctor (00201060485554, hadeer.nasser@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of post- operative pain. (time frame: 1 week changes from baseline pulp condition). The study lists 5 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 NCT06611631, which also lists 14 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 4 Nov 2024.