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

Cairo University (CU)

Status and phase: Not yet enrolling; Phase 1

Conditions: Pulp Disease, Dental; Pulpotomies Primary Teeth

Treatments: Procedure: Hyaluronic acid pulpotomy; Procedure: mineral trioxide aggregate pulpotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06611631

HA Pulpotomy

Details and patient eligibility

About

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?

Full 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 .

Enrollment: 34 estimated patients

Sex: All

Ages: 4 to 8 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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34 participants in 2 patient groups

Hyaluronic Acid Pulpotmoy

Experimental group

Description:

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.

Treatment:

Procedure: Hyaluronic acid pulpotomy

Mineral Trioxide Aggregate

Active Comparator group

Description:

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.

Treatment:

Procedure: mineral trioxide aggregate pulpotomy