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NCT Number: NCT06611631

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

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?

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Key information

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cairo University

Cairo, Egypt

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyaluronic acid pulpotomy

Procedure
  • 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.

Other names: HA pulpotomy

mineral trioxide aggregate pulpotomy

Procedure
  • 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.

Other names: MTA pulpotomy

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

Secondary outcomes

  1. 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.

    Intraoral digital periapical X-ray. Outcome measuring unit :Binary (present/absent)

  2. 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.

    Intraoral digital periapical X-ray. Outcome measuring unit :Binary (present/absent)

  3. 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.

    Intraoral digital periapical X-ray. Outcome measuring unit :Binary (present/absent)

Study contacts

Contact information is provided by the study sponsor or research team.

Hadeer Nasser Aboeldahb, Doctor

CONTACT

[email protected]

00201060485554

yasmin mohammed yossury, Ass.Prof

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Acronym: HA - MTA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2024
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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