Cairo University
Cairo, Egypt
NCT Number: NCT06611631
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?
Trial opening soon.
Get Notified4 year–8 year
All sexes
Interventional
Phase 1
Cairo, Egypt
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:
The benefits of this study to the clinicians:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Aged 4-8 years, in good general health and medically within normal.
Teeth:
Pre-operative Radiographic criteria:
Exclusion criteria
Patients:
Teeth:
Other names: HA pulpotomy
Other names: MTA pulpotomy
Time frame: 1 week changes from baseline pulp condition
Asking the patient and/or guardian. Outcome measuring unit :Binary (present/absent)
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)
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)
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)
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)
Time frame: at 3 month, change from the baseline pulp condition at 6 month, change from base line pulp condition at 12 month.
Intraoral digital periapical X-ray. Outcome measuring unit :Binary (present/absent)
Time frame: at 3 month, change from the baseline pulp condition at 6 month, change from base line pulp condition at 12 month.
Intraoral digital periapical X-ray. Outcome measuring unit :Binary (present/absent)
Time frame: at 3 month, change from the baseline pulp condition at 6 month, change from base line pulp condition at 12 month.
Intraoral digital periapical X-ray. Outcome measuring unit :Binary (present/absent)
Contact information is provided by the study sponsor or research team.
Hadeer Nasser Aboeldahb, Doctor
CONTACT
yasmin mohammed yossury, Ass.Prof
CONTACT
Cairo University
Other
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
Acronym: HA - MTA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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