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NCT06611631 | NOT YET RECRUITING | Pulpotomies Primary Teeth


Clinical and Radiographic Evaluation of Hyaluronic Acid (Gengigel Teething) Versus Mineral Trioxide Aggregate( Angelus) as Pulpotomy Agent in Vital Primary Molars
Sponsor:

Cairo University

Information provided by (Responsible Party):

Hadeer Nasser Hammad Aboeldahb

Brief 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. 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?

Condition or disease

Pulpotomies Primary Teeth

Pulp Disease, Dental

Intervention/treatment

Hyaluronic acid pulpotomy

mineral trioxide aggregate pulpotomy

Phase

PHASE1

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: 1. Providing better quality of dental treatment. 2. Enhance the overall oral health of children. The benefits of this study to the clinicians: 1. Providing a new biological and alternative treatment option. 2. Decreased chairside time owing to its better manipulation and less technique sensitive . 3. cheaper and accessible alternative .

Study Type : INTERVENTIONAL
Estimated Enrollment : 34 participants
Masking : TRIPLE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2025-03
Estimated Primary Completion Date : 2026-03
Estimated Study Completion Date : 2026-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 4 Years to 8 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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
        • * Absence of periapical or inter-radicular radiolucencies.
        • * Absence of widening of periodontal ligaments (PDL) space.
        • * Absence of internal or external root resorption.
        Exclusion Criteria
        • Patients
          • * With systemic disorders.
          • * Physical or mental disabilities.
          • * Unable to attend follow- up visits.
          • * Refusal of Participation.
          • * Refusal to sign the informed consent.
          • Teeth
            • * Previously accessed teeth.
            • * Mobile mandibular primary molars.
            • * Swelling in the vestibule or on palpation.
            • * Pain on percussion

Clinical and Radiographic Evaluation of Hyaluronic Acid (Gengigel Teething) Versus Mineral Trioxide Aggregate( Angelus) as Pulpotomy Agent in Vital Primary Molars

Location Details

NCT06611631


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Locations


Not yet recruiting

Egypt,

Cairo University

Cairo, Egypt,

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