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Postoperative Pain and Success Rate in Pulpotomy Versus Root Canal Treatment

Primary Purpose

Pulpitis - Irreversible

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pulpotomy
Root canal treatment
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulpitis - Irreversible focused on measuring Pulpotomy, Root canal treatment, Mature, Cariously exposed, Permanent molars, Irreversible pulpitis

Eligibility Criteria

9 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children from 9 to 15 years, in good general health and medically free.
  • Cariously exposed mature (complete root formation length and apical closure) permanent molars with reversible pulpitis, symptomatic or asymptomatic irreversible pulpits.
  • Teeth should be vital on cold testing.
  • Restorable teeth.
  • Vital bleeding present in all canals.
  • Hemostasis achieved after complete pulpotomy.
  • Preoperative radiograph:Absence of periapical or inter-radicular radiolucency, widening of PDL space, internal or external root resorption.

Exclusion Criteria:

  • Children with systemic diseases physical or mental disability, unable to attend follow-up visits or refuse participation.
  • Previously accessed teeth.
  • Necrotic teeth (negative response to cold testing or absence of bleeding after access cavity).
  • Presence of sinus tract or swelling.
  • Excessive bleeding after pulpotomy and not controlled after several minutes.
  • Teeth with marginal periodontitis or crestal bone loss.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Pulpotomy

    Root canal treatment

    Arm Description

    Group A (Experimental group) Pulpotomy: The teeth will be anesthetized with 4% articaine 1:100,000 epinephrine (Artinibsa®; Inibsa Dental, Lliçà de Vall, Spain) by inferior alveolar nerve block.Under rubber dam isolation, pulpotomy will be performed with a large sterile round end bur in a high speed hand piece with copious irrigation; pulp tissue will be removed by a sharp spoon excavator to the orifice level. Hemostasis will be achieved by the application of a wet cotton pellet moistened with 2.5% NaOCL for 2 min and repeated if needed. After hemostasis, Biodentine (Septodont, Saint Maur des Fausses, France) will be mixed according to the manufacturer's instructions and gently placed over the pulp to thickness of 2-3 mm.Biodentine will be covered by resin modified glass-ionomer and teeth will be restored using composite resin.A postoperative radiograph will be taken by parallel technique.

    Group B (control group) Root canal treatment: The teeth were anesthetized with 4% articaine 1:100,000 epinephrine (Artinibsa®; Inibsa Dental, Lliçà de Vall, Spain).Under rubber dam isolation, root canal treatment will be performed in single visit.Working length will be determined using stainless steel k-files (Mani, Inc.) keeping 0.5 to 1.0 mm short of the apex using a RootZX apex locator (J. Morita, Irvine, CA) and confirmed radiographically. Mechanical preparation will be achieved by a crown-down technique using using the M-PRO system (IMD, Shanghai, China) and irrigation with 5 mL 2.5% NaOCl between instruments.Obturation will be done with gutta-percha (Meta Biomed Co. Ltd, Cheongwongun, Chungbuk, Korea) and resin sealer ADseal (Meta Biomed CO., LTD, Korea) using cold lateral condensation technique and restored with composite resin with a base of glass-ionomer cement. A postoperative radiograph will be taken by parallel technique.

    Outcomes

    Primary Outcome Measures

    Postoperative pain: VAS (visual analogue scale)
    Postoperative pain reported by the patient after pulpotomy and root canal treatment by VAS (visual analogue scale).Scale from 0-10 recorded every 24hours until the fourth day. The VAS for pain is a straight line with one end (point 0) meaning no pain and the other end( point 10) meaning the worst pain imaginable

    Secondary Outcome Measures

    Swelling, sinus or fistula
    They will be assessed by visual examination.(Binary)
    Pain on percussion
    It will be assessed by percussion test .(Binary)
    Radiographic success
    It is defined as absence of inter-radicular or periapical radiolucency, widening of PDL space, internal or external root resorption).It will be assessed by periapical radiograph. parallel technique. Interpretation by Cohen's Kappa will be calculated.

    Full Information

    First Posted
    April 11, 2019
    Last Updated
    April 15, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03916900
    Brief Title
    Postoperative Pain and Success Rate in Pulpotomy Versus Root Canal Treatment
    Official Title
    Evaluation of Postoperative Pain and Success Rate After Pulpotomy Versus Root Canal Treatment in Cariously Exposed Mature Permanent Molars: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2019 (Anticipated)
    Primary Completion Date
    June 1, 2020 (Anticipated)
    Study Completion Date
    July 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

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

    5. Study Description

    Brief Summary
    Pulpotomy has been proposed in the last decade as a definitive treatment of mature permanent teeth with irreversible pulpitis due to the better understanding of the pulp biology and development of bioactive materials . This technique involves removal of the coronal portion of the pulp that has undergo degenerative and irreversible changes to the level of the canal orifices and leaving the healthy vital radicular portion of the pulp. The surrogate marker for the degree of inflammation and the healing potential of the remaining pulp tissue has been suggested to be the ability to control the bleeding after pulp amputation. By preserving the pulp vitality, this can help in maintaining proprioceptive, reparative, innervation (tooth sensitivity), vascularization, and damping functions. The vital pulp can continue to serve the function of protecting the tooth from overload by means of protective feedback mechanism and preventing fracture because of the presence of pulp and organic tissue in the dentinal tubules..
    Detailed Description
    The routine dental treatment for the patient diagnosed with symptomatic or asymptomatic irreversible pulpitis secondary to deep carious lesion is conventional root canal treatment. Root canal treatment is the preferred treatment option because of its superior success rate to other treatments . However, it is expensive, time consuming and complicated. Root canal treatment needs special clinical skills and high socio-economic status to afford the cost of the treatment. Unfortunately, in developing countries these can be un-reachable. Therefore, extraction is the only alternative option to the affected teeth . Moreover, a recent systematic review by Ng et al stated that the success rate of root canal treatment had not improved over the past few decades and molars had poor survival rates in comparison to non-molar teeth.In addition, It was stated that the survival rate of endodontically treated tooth is alarmingly low in comparison to vital teeth, especially molars, During root canal treatment many mishaps can occur such as perforations, ledges and extrusion of root filling, that reduces the longevity of root treated teeth . Carious pulp exposure of permanent molars in children is a very common unfortunate event faced in Pediatric Dentistry and Public Health department in Cairo university. This may be due to the low socioeconomic status, ignorance of patients attending that clinic, their wrong eating habits and their bad oral hygiene. Root canal treatment in an uncooperative young patient is very complicated which may affect the quality and prognosis of the treatment itself. Therefore, an economical, simple and conservative technique such as pulpotomy should be considered Pulpotomy has been proposed in the last decade as a definitive treatment of mature permanent teeth with irreversible pulpitis due to the better understanding of the pulp biology and development of bioactive materials . This technique involves removal of the coronal portion of the pulp that has undergo degenerative and irreversible changes to the level of the canal orifices and leaving the healthy vital radicular portion of the pulp. The surrogate marker for the degree of inflammation and the healing potential of the remaining pulp tissue has been suggested to be the ability to control the bleeding after pulp amputation.. By preserving the pulp vitality, this can help in maintaining proprioceptive, reparative, innervation (tooth sensitivity), vascularization, and damping functions.The vital pulp can continue to serve the function of protecting the tooth from overload by means of protective feedback mechanism and preventing fracture because of the presence of pulp and organic tissue in the dentinal tubules.The dentin -pulp complex will stimulate the formation of tertiary dentine or a mineralized barrier protecting itself . Compared to the root canal treatment, pulpotomy is considered less technique sensitive so it can be performed by general dental practitioners. Hence, It increases the patients' access to dental care and more clinicians will be able to provide the affordable treatment saving more teeth when the patients cannot afford the root canal treatment leaving extraction as a last treatment option. It is believed that the pulp tissue of the younger aged patients has higher healing capacity and regenerative powers than pulp tissue in older aged patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulpitis - Irreversible
    Keywords
    Pulpotomy, Root canal treatment, Mature, Cariously exposed, Permanent molars, Irreversible pulpitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Parallel assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    52 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pulpotomy
    Arm Type
    Experimental
    Arm Description
    Group A (Experimental group) Pulpotomy: The teeth will be anesthetized with 4% articaine 1:100,000 epinephrine (Artinibsa®; Inibsa Dental, Lliçà de Vall, Spain) by inferior alveolar nerve block.Under rubber dam isolation, pulpotomy will be performed with a large sterile round end bur in a high speed hand piece with copious irrigation; pulp tissue will be removed by a sharp spoon excavator to the orifice level. Hemostasis will be achieved by the application of a wet cotton pellet moistened with 2.5% NaOCL for 2 min and repeated if needed. After hemostasis, Biodentine (Septodont, Saint Maur des Fausses, France) will be mixed according to the manufacturer's instructions and gently placed over the pulp to thickness of 2-3 mm.Biodentine will be covered by resin modified glass-ionomer and teeth will be restored using composite resin.A postoperative radiograph will be taken by parallel technique.
    Arm Title
    Root canal treatment
    Arm Type
    Active Comparator
    Arm Description
    Group B (control group) Root canal treatment: The teeth were anesthetized with 4% articaine 1:100,000 epinephrine (Artinibsa®; Inibsa Dental, Lliçà de Vall, Spain).Under rubber dam isolation, root canal treatment will be performed in single visit.Working length will be determined using stainless steel k-files (Mani, Inc.) keeping 0.5 to 1.0 mm short of the apex using a RootZX apex locator (J. Morita, Irvine, CA) and confirmed radiographically. Mechanical preparation will be achieved by a crown-down technique using using the M-PRO system (IMD, Shanghai, China) and irrigation with 5 mL 2.5% NaOCl between instruments.Obturation will be done with gutta-percha (Meta Biomed Co. Ltd, Cheongwongun, Chungbuk, Korea) and resin sealer ADseal (Meta Biomed CO., LTD, Korea) using cold lateral condensation technique and restored with composite resin with a base of glass-ionomer cement. A postoperative radiograph will be taken by parallel technique.
    Intervention Type
    Procedure
    Intervention Name(s)
    Pulpotomy
    Intervention Description
    Pulpotomy is a procedure in which the coronal pulp is amputated, and the remaining radicular pulp tissue is treated with a medicament to preserve the pulp's health .This technique involves administration of local analgesia, Isolation of the tooth with rubber dam, Complete caries removal and then access to the pulp chamber using drills
    Intervention Type
    Procedure
    Intervention Name(s)
    Root canal treatment
    Intervention Description
    Root canal treatment is an often straightforward procedure to relieve dental pain and save teeth. Patients typically need a root canal when there is inflammation or infection in the roots of a tooth. During root canal treatment, an endodontist who specializes in such treatment carefully removes the pulp inside the tooth, cleans, disinfects and shapes the root canals, and places a filling to seal the space.
    Primary Outcome Measure Information:
    Title
    Postoperative pain: VAS (visual analogue scale)
    Description
    Postoperative pain reported by the patient after pulpotomy and root canal treatment by VAS (visual analogue scale).Scale from 0-10 recorded every 24hours until the fourth day. The VAS for pain is a straight line with one end (point 0) meaning no pain and the other end( point 10) meaning the worst pain imaginable
    Time Frame
    4 days postoperatively
    Secondary Outcome Measure Information:
    Title
    Swelling, sinus or fistula
    Description
    They will be assessed by visual examination.(Binary)
    Time Frame
    9 months
    Title
    Pain on percussion
    Description
    It will be assessed by percussion test .(Binary)
    Time Frame
    9 months
    Title
    Radiographic success
    Description
    It is defined as absence of inter-radicular or periapical radiolucency, widening of PDL space, internal or external root resorption).It will be assessed by periapical radiograph. parallel technique. Interpretation by Cohen's Kappa will be calculated.
    Time Frame
    9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    9 Years
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Children from 9 to 15 years, in good general health and medically free. Cariously exposed mature (complete root formation length and apical closure) permanent molars with reversible pulpitis, symptomatic or asymptomatic irreversible pulpits. Teeth should be vital on cold testing. Restorable teeth. Vital bleeding present in all canals. Hemostasis achieved after complete pulpotomy. Preoperative radiograph:Absence of periapical or inter-radicular radiolucency, widening of PDL space, internal or external root resorption. Exclusion Criteria: Children with systemic diseases physical or mental disability, unable to attend follow-up visits or refuse participation. Previously accessed teeth. Necrotic teeth (negative response to cold testing or absence of bleeding after access cavity). Presence of sinus tract or swelling. Excessive bleeding after pulpotomy and not controlled after several minutes. Teeth with marginal periodontitis or crestal bone loss.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Aya A Elsayed, BDS
    Phone
    00201090802757
    Email
    aya.alaa@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Aya A Abdelaziz, BDS
    Phone
    00201090802757
    Email
    aya.alaa@dentistry.cu.edu.eg

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    study protocol, informed consent, clinical study report
    IPD Sharing Time Frame
    9 months after completion of the study
    IPD Sharing Access Criteria
    ClinicalTrials.gov
    IPD Sharing URL
    http://ClinicalTrials.gov

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