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

November 1, 2024 updated by: Hadeer Nasser Hammad Aboeldahb, Cairo University

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

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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

34

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyaluronic Acid Pulpotmoy
  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.
Procedure: Hyaluronic acid pulpotomy
  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.
Other Names:
  • HA pulpotomy
Active Comparator: Mineral Trioxide Aggregate
  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.
Procedure: mineral trioxide aggregate pulpotomy
  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.
Other Names:
  • MTA pulpotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 week changes from baseline pulp condition
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)
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.
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)
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.
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)
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.
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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
at 3 month, change from the baseline pulp condition at 6 month, change from base line pulp condition at 12 month.
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)
at 3 month, change from the baseline pulp condition at 6 month, change from base line pulp condition at 12 month.
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)
at 3 month, change from the baseline pulp condition at 6 month, change from base line pulp condition at 12 month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

September 22, 2024

First Submitted That Met QC Criteria

September 22, 2024

First Posted (Actual)

September 25, 2024

Study Record Updates

Last Update Posted (Estimated)

November 4, 2024

Last Update Submitted That Met QC Criteria

November 1, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HA Pulpotomy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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