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Evaluation of Different Materials in Pulpotomy of Primary Molars

Primary Purpose

Pulp Disease, Dental

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mineral trioxide aggregate pulpotomy
Dehydrated amniotic membrane pulpotomy
Hyaluronic acid pulpotomy
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulp Disease, Dental

Eligibility Criteria

4 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Mineral trioxide aggregate (positive control group)

    Dehydrated amniotic membrane group

    Hyaluronic acid group

    Arm Description

    : 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.

    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.

    • 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) .

    Outcomes

    Primary Outcome Measures

    clinical pulp testing
    pulp testing clinically measured by zurn and seale criteria ,
    Radio graphic pulp testing
    pulp testing radio graphic measured by digital radio graph parallel technique

    Secondary Outcome Measures

    Full Information

    First Posted
    January 26, 2023
    Last Updated
    August 22, 2023
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05981352
    Brief Title
    Evaluation of Different Materials in Pulpotomy of Primary Molars
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    October 1, 2024 (Anticipated)
    Study Completion Date
    October 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes

    5. Study Description

    Brief 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).
    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 .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulp Disease, Dental

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    36 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Mineral trioxide aggregate (positive control group)
    Arm Type
    Active Comparator
    Arm Description
    : 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.
    Arm Title
    Dehydrated amniotic membrane group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Hyaluronic acid group
    Arm Type
    Experimental
    Arm Description
    • 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) .
    Intervention Type
    Procedure
    Intervention Name(s)
    mineral trioxide aggregate pulpotomy
    Intervention Description
    After achieving hemostats, Mineral trioxide aggregate powder will be mixed with saline. Then Mineral trioxide aggregate will be placed directly on the pulp stumps.
    Intervention Type
    Procedure
    Intervention Name(s)
    Dehydrated amniotic membrane pulpotomy
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Hyaluronic acid pulpotomy
    Intervention Description
    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 .
    Primary Outcome Measure Information:
    Title
    clinical pulp testing
    Description
    pulp testing clinically measured by zurn and seale criteria ,
    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.
    Title
    Radio graphic pulp testing
    Description
    pulp testing radio graphic measured by digital radio graph parallel technique
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    8 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    eman Ib Abdel Masoud, doctor
    Phone
    01555682322
    Email
    eman.abdelmaksoud@dent.asu.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    eman Ib Abdel Maksoud, doctor
    Organizational Affiliation
    Ain Shams University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of Different Materials in Pulpotomy of Primary Molars

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