Clinical trial NCT06611631: Clinical and Radiographic Evaluation of Hyaluronic Acid (Gengigel Teething) Versus Mineral Trioxide Aggregate( Angelus) as Pulpotomy Agent in Vital Primary Molars
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Pulpotomies Primary Teeth
Pulp Disease, Dental
Keywords: hyaluronic acid
HA
MTA
Mineral Trioxide Aggregate
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-09-25
Enrollment: 34
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

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 .

Eligibility 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

Primary outcomes:
measure: Absence of post- operative pain.
timeFrame: 1 week changes from baseline pulp condition
measure: Absence of pain on percussion.
timeFrame: 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.
measure: Absence of Swelling.
timeFrame: 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.
measure: Absence of Sinus or fistula.
timeFrame: 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.
measure: Pathologic mobility
timeFrame: 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:
measure: Absence of external or internal root resorption.
timeFrame: at 3 month, change from the baseline pulp condition at 6 month, change from base line pulp condition at 12 month.
measure: Absence of furcation or periapical radiolucency.
timeFrame: at 3 month, change from the baseline pulp condition at 6 month, change from base line pulp condition at 12 month.
measure: Absence of any adverse radiographic finding.
timeFrame: at 3 month, change from the baseline pulp condition at 6 month, change from base line pulp condition at 12 month.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
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