search
Back to results

Comparative Evaluation of Eggshell Powder in Primary Teeth Pulpotomy

Primary Purpose

Pulpitis Reversible, Pulp Exposure, Dental

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
pulpotomy
cone beam computed tomography (CBCT) assessment
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulpitis Reversible focused on measuring Cone-beam computed tomography, tea-tree oil, egg shell powder, biodentine

Eligibility Criteria

4 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Restorable primary molars with deep carious lesions. Absence of gingival swelling or sinus tract. Absence of spontaneous pain Absence of pain on percussion. Absence of discontinuity of lamina dura Absence of internal root resorption. Absence of external root resorption. Absence of inter-radicular or periapical bone destruction (radiolucency). Exclusion Criteria: presence of spontaneous pain presence of gingival swelling or sinus tract presence of internal or external root resorption pain on percussion.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    group 1: Tea Tree Oil- Eggshell Powder

    group II: biodentine

    group III: mineral tri-oxide aggregate (MTA)

    Arm Description

    30 primary molars will be treated with Eggshell Powder freshly mixed with Tea Tree Oil till reach suitable consistency (1:1 ratio by volume) to cover pulp stumps

    30 primary molars will be treated with biodentine to cover pulp stumps

    30 primary molars will be treated with MTA to cover pulp stumps

    Outcomes

    Primary Outcome Measures

    absence of pain
    Measuring Method: Verbal Question to Patient /Parents Measuring Unite: score 0 for absence of pain and score 1 for presence of pain
    absence of fistula
    Measuring Method: Visual examination by operator Measuring Unite: score 0 for absence of swelling and score 1 for presence of swelling
    Tenderness to percussion
    Measuring Method: Percussion test Measuring Unite: Binary (+/-)
    Furcation radiolucency
    Measuring Method: cone beam computed tomography (CBCT) for assessment of radio-density of bone at the furcation area Measuring Unite: Binary (+/-)
    Furcation radiolucency
    Measuring Method: cone beam computed tomography (CBCT) for assessment of radio-density of bone at the furcation area Measuring Unite: Binary (+/-)

    Secondary Outcome Measures

    Full Information

    First Posted
    March 21, 2023
    Last Updated
    April 1, 2023
    Sponsor
    Tanta University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05812053
    Brief Title
    Comparative Evaluation of Eggshell Powder in Primary Teeth Pulpotomy
    Official Title
    Comparative Evaluation of Eggshell Powder Versus Biodentine in Primary Teeth Pulpotomy: Clinical And Radiographic Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2023 (Anticipated)
    Primary Completion Date
    March 2024 (Anticipated)
    Study Completion Date
    April 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tanta University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To assess & compare clinical & radiographic effects of Tea Tree Oil- Eggshell Powder and Biodentine as pulpotomy agents in primary teeth.
    Detailed Description
    Pulpotomy is the most widely accepted technique for treating primary teeth with deep carious lesion, pulp exposure during the operatory process or after a traumatic pulp exposure. Mineral trioxide aggregate (MTA) is one such material that has shown tremendous potential for regeneration. Biodentine™ (hydraulic silicate cement) is a novel dental material with high mechanical characteristics as well as superior biocompatibility and bioactive behaviour. Nowadays, chicken eggshell powder (CESP) (a natural calcium-rich source) is achieving wide acceptance in the medical and dental fields. Tea tree oil is the essential oil extracted from the Australian native Melaleuca alternifolia or the tea tree. To date, there is insufficient evidence to properly evaluate Tea Tree Oil- Eggshell Powder as a pulpotomy agent in primary teeth; thus, the current study aimed to assess and compare clinical and radiographical success of Tea Tree Oil- Eggshell Powder and Biodentine as pulpotomy agents in primary teeth.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulpitis Reversible, Pulp Exposure, Dental
    Keywords
    Cone-beam computed tomography, tea-tree oil, egg shell powder, biodentine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    group 1: Tea Tree Oil- Eggshell Powder
    Arm Type
    Experimental
    Arm Description
    30 primary molars will be treated with Eggshell Powder freshly mixed with Tea Tree Oil till reach suitable consistency (1:1 ratio by volume) to cover pulp stumps
    Arm Title
    group II: biodentine
    Arm Type
    Experimental
    Arm Description
    30 primary molars will be treated with biodentine to cover pulp stumps
    Arm Title
    group III: mineral tri-oxide aggregate (MTA)
    Arm Type
    Active Comparator
    Arm Description
    30 primary molars will be treated with MTA to cover pulp stumps
    Intervention Type
    Procedure
    Intervention Name(s)
    pulpotomy
    Intervention Description
    Teeth will be anesthetized then Rubber dam and high suction will be used in pulpotomy procedure. Cavity outline was performed by sterile #330 high speed bur using water spray. Caries was removed by large spoon excavator. When pulpal exposure occurred, the roof of pulp chamber removed by low speed round bur. Haemostasis was obtained by applying pressure with moist cotton pellet with saline. Then the test materials was applied. after that, pulp stumps of all molars in each group will be dressed using Intermediate restorative material then the tooth will be restored with a preformed stainless steel crown
    Intervention Type
    Radiation
    Intervention Name(s)
    cone beam computed tomography (CBCT) assessment
    Intervention Description
    a post-operative CBCT image will be taken immediately after completing the procedure with fixed exposure parameters (120 Kv, 5mA, and 0.125mm voxel size) using the smallest field of view (8D, 8Hcm) also, after 6 and 12 months follow-up periods.
    Primary Outcome Measure Information:
    Title
    absence of pain
    Description
    Measuring Method: Verbal Question to Patient /Parents Measuring Unite: score 0 for absence of pain and score 1 for presence of pain
    Time Frame
    up to 12 months
    Title
    absence of fistula
    Description
    Measuring Method: Visual examination by operator Measuring Unite: score 0 for absence of swelling and score 1 for presence of swelling
    Time Frame
    up to 12 months
    Title
    Tenderness to percussion
    Description
    Measuring Method: Percussion test Measuring Unite: Binary (+/-)
    Time Frame
    Up to 12 month
    Title
    Furcation radiolucency
    Description
    Measuring Method: cone beam computed tomography (CBCT) for assessment of radio-density of bone at the furcation area Measuring Unite: Binary (+/-)
    Time Frame
    6 months
    Title
    Furcation radiolucency
    Description
    Measuring Method: cone beam computed tomography (CBCT) for assessment of radio-density of bone at the furcation area Measuring Unite: Binary (+/-)
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    7 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Restorable primary molars with deep carious lesions. Absence of gingival swelling or sinus tract. Absence of spontaneous pain Absence of pain on percussion. Absence of discontinuity of lamina dura Absence of internal root resorption. Absence of external root resorption. Absence of inter-radicular or periapical bone destruction (radiolucency). Exclusion Criteria: presence of spontaneous pain presence of gingival swelling or sinus tract presence of internal or external root resorption pain on percussion.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29744721
    Citation
    Celik BN, Mutluay MS, Arikan V, Sari S. The evaluation of MTA and Biodentine as a pulpotomy materials for carious exposures in primary teeth. Clin Oral Investig. 2019 Feb;23(2):661-666. doi: 10.1007/s00784-018-2472-4. Epub 2018 May 10.
    Results Reference
    background
    PubMed Identifier
    23683272
    Citation
    Nowicka A, Lipski M, Parafiniuk M, Sporniak-Tutak K, Lichota D, Kosierkiewicz A, Kaczmarek W, Buczkowska-Radlinska J. Response of human dental pulp capped with biodentine and mineral trioxide aggregate. J Endod. 2013 Jun;39(6):743-7. doi: 10.1016/j.joen.2013.01.005. Epub 2013 Apr 10.
    Results Reference
    background
    PubMed Identifier
    17483877
    Citation
    Siva Rama Krishna D, Siddharthan A, Seshadri SK, Sampath Kumar TS. A novel route for synthesis of nanocrystalline hydroxyapatite from eggshell waste. J Mater Sci Mater Med. 2007 Sep;18(9):1735-43. doi: 10.1007/s10856-007-3069-7. Epub 2007 May 5.
    Results Reference
    background
    PubMed Identifier
    25083027
    Citation
    Kattimani VS, Chakravarthi PS, Kanumuru NR, Subbarao VV, Sidharthan A, Kumar TS, Prasad LK. Eggshell derived hydroxyapatite as bone graft substitute in the healing of maxillary cystic bone defects: a preliminary report. J Int Oral Health. 2014 Jun;6(3):15-9. Epub 2014 Jun 26.
    Results Reference
    background
    PubMed Identifier
    11131302
    Citation
    Hart PH, Brand C, Carson CF, Riley TV, Prager RH, Finlay-Jones JJ. Terpinen-4-ol, the main component of the essential oil of Melaleuca alternifolia (tea tree oil), suppresses inflammatory mediator production by activated human monocytes. Inflamm Res. 2000 Nov;49(11):619-26. doi: 10.1007/s000110050639.
    Results Reference
    background

    Learn more about this trial

    Comparative Evaluation of Eggshell Powder in Primary Teeth Pulpotomy

    We'll reach out to this number within 24 hrs