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Pulp Disease, DentalNCT05981352

Evaluation of Different Materials in Pulpotomy of Primary Molars

A study testing mineral trioxide aggregate pulpotomy, Dehydrated amniotic membrane pulpotomy and Hyaluronic acid pulpotomy in people with Pulp Disease, Dental, run by Ain Shams University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of the current study is to evaluate and compare clinical and radiographic success and antibacterial effect of Hyaluronic Acid and Amniotic membrane pulpotomy in primary molars in comparison with MTA pulpotomy (Randomized Clinical Trial and In Vitro Study). Read more about this study

Who is it for?
Ages 4 to 8 years
Conditions the study is for
Pulp Disease, Dental
What is being tested?
mineral trioxide aggregate pulpotomy, Dehydrated amniotic membrane pulpotomy and Hyaluronic acid pulpotomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
No sites listed yet
Study dates
Oct 2023to 1 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 8 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Patients aged from 4 to 8 years old.
  • Patients who are free from ant medical condition.
  • Patients who have a vital deep carious Mandibular primary molar which is indicated for pulpotomy .
  • No clinical signs or symptoms of irreversible pulpitis as pain on percussion, tooth mobility, presence of sinus or fistula, history of swelling , Spontaneous pain.
  • No radiographic evidence of any periapical pathosis , Internal or external root resorption , Absence of discontinuity of lamina dura .
  • Physiological root resorption not more than 1/3 of crown

Who cannot join

  • Teeth that are badly broken down, that cannot be restored.
  • Presence of uncontrolled bleeding after pulpotomy
  • Patients/ parent guardians that refuse to sign informed consent.

Trial locations and contacts

No sites are listed yet.

eman Ib Abdel Masoud, doctor contact

01555682322

eman.abdelmaksoud@dent.asu.edu.eg

About this study

Official title: Clinical, Radiographic and Microbiological Evaluation of Hyaluronic Acid and Amniotic Membrane Allograft in Comparison to Mineral Trioxide Aggregate in Pulpotomy of Primary Molars (Randomized Clinical Trial and In Vitro Study)

The aim of the current study is to evaluate and compare clinical and radiographic success and antibacterial effect of Hyaluronic Acid and Amniotic membrane pulpotomy in primary molars in comparison with MTA pulpotomy (Randomized Clinical Trial and In Vitro Study).

Read the detailed description

Pulpotomy is one of the most used frequently treatment for pulp involved in primary teeth. Pulpotomy is performed in a primary tooth with extensive caries but without evidence of radicular pathology when caries removal results in a carious or mechanical pulp exposure. It is a conservative therapy performed to remove the inflamed coronal pulp tissues followed by application of an effective and compatible bactericidal medicament.

Many different compounds have been suggested include glutaraldehyde, electrosurgery, calcium hydroxide, ferric sulfate, freeze-dried bone, bone morphogenic proteins (BMP), mineral trioxide aggregate (MTA) and Bio dentine (Tricalcium Silicate Cement) as replacement for Form cresol in pulpotomy procedure however.

Pulpotomy has been broadly classified as devitalization, preservation, and regeneration of the remaining pulp tissue. Other materials that has shown immense potential for regeneration like mineral trioxide aggregate (MTA). It is a biocompatible and bio inductive material that has been investigated for endodontic.

Hyaluronic acid (HA) has recently emerged as a material of choice in preserving the vitality of the pulp. It is a natural mucopolysaccharide, carbohydrate polymer from the group of glycosaminoglycans. HA is synthetized on the cytoplasmic surface of plasma membranes and is common in humans and other vertebrates. It is the major component of the inner-cell cement of the capillary wall, and of the extracellular matrix of the connective tissue. Deposition of HA significantly increases during development, morphogenesis, wound repair and regeneration, malignancy, and inflammation.

Hyaluronic acid (HA) or hyaluronan is a hydrated anionic polysaccharide plentiful in the extracellular matrix with a molecular weight of 4000-20,000,000 Da that is found in a variety of tissues including skin, synovial fluid, cartilage, tendons, eyes and embryonic mesenchyme . It is comprised of repeating disaccharides d-glucuronic acid and N-acetyl-d-glucosamine, which are joined together by alternating β-1,4 and β-1,3 glycoside bonding. During bone repair, it encourages the undifferentiated mesenchymal cells to migrate, adhere, and proliferate into osteoblastic cells. Due to its non-toxicity, biocompatibility, biodegradability and non-immunogenicity, and used in ophthalmology and orthopedics as an anti-inflammatory agent and anti bacterial agent.

The use of a hyaluronic acid to cover a dentin defect, stimulated a cell-rich rearrangement of pulp tissue with few inflammatory cells, as well as being an acceptable and biocompatible scaffold for regenerating the dental pulp. Because of its high molecular weight when dissolved in water, hyaluronic acid's viscoelasticity increases, making it simpler to use as an injectable scaffold. Moreover, advantageous characteristics are related to the hyaluronic acid scaffolds as bioactivity, biocompatibility, biodegradability, in addition to serving as a reservoir for growth factors..

It is important to propose new biologically based therapeutics directed at preserving pulp vitality , forming biological tissue and neutralizing the side effects of previously used synthetically based biomaterials .

Recently, novel biologically based materials have been developed from the placenta or other gestational tissues like the umbilical cord with highly rich stem cell reservoirs . Amniotic membrane (AM) is a fetes membranous sac forming the innermost layer of the placenta. It is a bi-layered membrane consists of amnion and chorion. Amnion consists of 3 distinct thin layers: an epithelial monolayer (closest to the fetes),a basement membrane and avascular mesenchymal stromal matrix (containing mesenchymal stem cells) that composed of 3 adjacent but distinct layers: outermost spongy, middle fibroblastic and inner compact.

Although it is a thin membrane (70-180 μm thick), it is remarkably elastic and strong natural biological barricade protecting the fetus from trauma and bacterial infection . In contrast, the chorion is 3-4 times thicker than amnion and consists of a reticular, basement membrane, and trophoblastic layers. Both membranes play important roles in embryo's overall development, embryo's nourishment and breathing .

Amniotic membrane matrix contains plenteous growth factors (GFs) including basic-fibroblast growth factor (b-FGF), nidogen growth factor (NGF), keratinocyte growth factor (KGF), epidermal derived growth factor (EDGF), and transforming GF-beta growth factor (TGF-β) which promote tissue regeneration . These GFs mimic the stem cell niche for ex vivo growth and provide a natural healing environment. It acts as a structural scaffold supporting proliferation, differentiation, and regeneration due to presence of fibronectin, laminins, proteoglycans, collagen types I, III, IV, V and VI, elastin, nidogen, and hyaluronic acid in its stromal layer, and act as an excellent candidature for a native scaffold in tissue engineering .

Furthermore, it secretes nutrient factors , promotes cell migration, adhesion, differentiation, and suppresses the semi allogenic immune response against the foetus . In addition, it has a biological, anti-inflammatory (similar to cortisone and steroids shots), anti-fibrotic, anti-microbial (including beta-defensins), anti-scarring, anti-angiogenic and analgesic properties that make it a unique therapy for wound care and ideal substrate for supporting the growth of mesenchymal progenitor cells via prolonging their lifespan

It is used in allotransplant due to its ability to promote cellular growth and attachment with the lack of its immunogenicity and toxicity; it was first reported by Davis since 1910 in skin transplantation. Also, it has been used successfully for over a decade in a wide range of surgical application, biological wound dressing, ophthalmic reconstructive surgery, an adhesion barrier in the spine, and in-ear and orthopedic surgery. It is easily obtained, processed, transported, and prepared in different forms for clinical use like fresh, dried, frozen, freeze derived irradiated, stabilized amniotic and cryopreserved membranes .

Amnion-based products have a proven rate of success in the field of dentistry since 1990s, when first demonstrated safety and efficacy in pre-and clinical studies . The dehydrated or cryopreserved membrane is used for retaining the majority of the natural (fibrillar and membranous) collagens, maintaining the composition of GFs and bioactive molecules found in natural and unprocessed placental tissues, and increasing stability and shelf life of the product .

Being tested
mineral trioxide aggregate pulpotomy, Dehydrated amniotic membrane pulpotomy, Hyaluronic acid pulpotomy
Medical subject headings
Dental Pulp Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mineral trioxide aggregate pulpotomyProcedure or surgery

    • After achieving hemostats, Mineral trioxide aggregate powder will be mixed with saline.
    • Then Mineral trioxide aggregate will be placed directly on the pulp stumps.
  • Dehydrated amniotic membrane pulpotomyProcedure or surgery

    • After achieving haemostasis, a double layer of sterile processed human allograft tis¬sue (dehydrated dual-layer dental amni¬on patch) will be trimed and soaked in saline for a minute.
    • Dehydrated amniotic membrane will be Placed directly on the pup stumps using sterile tweezers and adjust¬ed to the entire floor of the pulp chamber.
  • Hyaluronic acid pulpotomyProcedure or surgery

    • After achieving haemostasis, pulp stumps will be covered with a mixture of Hyaluronic acid gel and zinc oxide powder with consistency (1:1 ratio by volume) .
    • The cavities of all pulpotomy molars will be sealed with a layer of reinforced zinc oxide and eugenol .
Study groups in NCT05981352
Study groupRoleWhat they receive
Mineral trioxide aggregate (positive control group)Active comparator: according to the manufacturing instructions as following: * After achieving hemostasis, Mineral trioxide aggregate powder will be mixed with saline. * Then Mineral trioxide aggregate will be placed directly on the pulp stumps.
Receives: Procedure: mineral trioxide aggregate pulpotomy
Dehydrated amniotic membrane groupExperimental* After achieving hemostasis, a double layer of sterile processed human allograft tissue (dehydrated dual-layer dental amnion patch) will be trimmed and soaked in saline for a minute. * Dehydrated amniotic membrane will be Placed directly on the pup stumps using sterile tweezers and adjusted to the entire floor of the pulp chamber.
Receives: Procedure: Dehydrated amniotic membrane pulpotomy
Hyaluronic acid groupExperimental• After achieving hemostasis, pulp stumps will be covered with a mixture of Hyaluronic acid gel and zinc oxide powder with consistency (1:1 ratio by volume) .
Receives: Procedure: Hyaluronic acid pulpotomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. clinical pulp testing

    pulp testing clinically measured by zurn and seale criteria ,

    Measured: 0 baseline , changes from baseline pulp condition 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.

  2. Radio graphic pulp testing

    pulp testing radio graphic measured by digital radio graph parallel technique

    Measured: 0 baseline , changes from baseline pulp condition 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2023
  2. Study startOct 2023 (estimated)
  3. Primary completion1 Oct 2024 (estimated)
  4. Study completion1 Oct 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05981352
Sponsor's protocol ID
Pulpotomy of Primary Molars
Status last verified
May 2023
First submitted
26 Jan 2023
Last updated
24 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing mineral trioxide aggregate pulpotomy, Dehydrated amniotic membrane pulpotomy and Hyaluronic acid pulpotomy in people with Pulp Disease, Dental, run by Ain Shams University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact eman Ib Abdel Masoud, doctor (01555682322, eman.abdelmaksoud@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

clinical pulp testing (time frame: 0 baseline , changes from baseline pulp condition 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.

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