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

ConditionsPulpotomies Primary TeethPulp Disease, Dental
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age4-8
SponsorCairo University

About this 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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Restorable mandibular primary molars.

History of reversible pulpitis.

Absence of periapical or inter-radicular radiolucencies.

Absence of widening of periodontal ligaments (PDL) space.

Disqualifiers

With systemic disorders.

Physical or mental disabilities.

Unable to attend follow- up visits.

Refusal of Participation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hyaluronic acid pulpotomy

    Procedure/Surgery

    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.

  • mineral trioxide aggregate pulpotomy

    Procedure/Surgery

    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 groups

34 Participants
are divided into 2 treatment groups
Group A: Hyaluronic Acid PulpotmoyExperimental treatment 1 intervention
Group B: Mineral Trioxide AggregateActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Absence of post- operative pain.

Asking the patient and/or guardian. Outcome measuring unit :Binary (present/absent)

Time frame
1 week changes from baseline pulp condition
2

Absence of pain on percussion.

Percussion test using the back of a dental mirror. Outcome measuring unit :Binary (present/absent)

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.
3

Absence of Swelling.

Visual examination. Outcome measuring unit :Binary (present/absent)

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.
4

Absence of Sinus or fistula.

Visual examination. Outcome measuring unit :Binary (present/absent)

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.

Secondary outcomes

1

Absence of external or internal root resorption.

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

Time frame
at 3 month, change from the baseline pulp condition at 6 month, change from base line pulp condition at 12 month.
2

Absence of furcation or periapical radiolucency.

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

Time frame
at 3 month, change from the baseline pulp condition at 6 month, change from base line pulp condition at 12 month.
3

Absence of any adverse radiographic finding.

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

Time frame
at 3 month, change from the baseline pulp condition at 6 month, change from base line pulp condition at 12 month.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: