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Stepwise and One Step Techniques In Deep Dentin Lesion

Primary Purpose

Dental Caries, Dental Pulp Exposure

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Stepwise Excavation
One Step Excavation
Sponsored by
TIJEN PAMIR
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries, Dental Pulp Exposure focused on measuring Selective Caries Removal, Deep Dentin Lesion, Permanent Teeth, Stepwise and One Step Excavation Technique

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Molar teeth with primary caries lesion prolonged of 75 percentage or more of dentin radiographically1 Existence of vitality with positive response to

    • electrical pulp test and
    • cold test
  • No history of spontaneous pain on the teeth
  • No sign of pain on percussion and palpation (sensitivity)

Exclusion Criteria:

  • Individuals with the systemic disease who require hospitalization (oncological treatment, transplantation patients)
  • Patients with uncontrolled hyperglycaemia or using insulin
  • Patients with pregnancy/suspected
  • Observation of radiolucency in the apex of the relevant tooth (PAI> 2)
  • Secondary decayed teeth

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    SW

    OneS

    Arm Description

    stepwise excavation

    one step excavation

    Outcomes

    Primary Outcome Measures

    Pulpal Success Assessment
    Presence of vitality in treated tooth with positive response to electrical and thermal stimuli, no history of spontaneous pain and no response to percussion and pain (sensitivity) sign in palpation
    Health Status of Periapical Tissue
    According to Orstavik' Periapical Index (PAI), Periapical Index score scale are 1to 5 : scoring with PAI 1 or PAI 2 refer to healthy tooth but PAI 3, PAI 4 and PAI 5 as worse outcome for periapical tissue that sing of periapical tissue damage

    Secondary Outcome Measures

    Full Information

    First Posted
    April 14, 2020
    Last Updated
    August 30, 2021
    Sponsor
    TIJEN PAMIR
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04351048
    Brief Title
    Stepwise and One Step Techniques In Deep Dentin Lesion
    Official Title
    The Evaluation of Stepwise and One Step Excavation Techniques In The Management of Deep Dentin Lesions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 12, 2016 (Actual)
    Primary Completion Date
    March 2, 2018 (Actual)
    Study Completion Date
    March 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    TIJEN PAMIR

    4. Oversight

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

    5. Study Description

    Brief Summary
    This double blind, randomized, controlled clinical trial aimed to observe the success of stepwise (SW) and one step (OneS) excavation techniques in the management of deep dentin caries. Additionally, evaluation of glass ionomer cement (GIC) as temporary restorative was also performed. For this purpose, forty participants were selected among the routine patients coming to university clinic. A permanent tooth having caries lesions penetrating to 75 percentage or more of dentin of patient were included. Randomization to SW and OneS groups were organized by coin method. The periphery of the cavities including enamel-dentin junction was cleaned until reach to hard dentin. Afterwards, selective removal to soft dentin on the pulpal side of the cavities was applied manually excavation and covered with pure calcium hydroxide and zinc oxide eugenol cement. GIC was used for temporary filling. This process was implemented both the first stage excavation of SW and OneS groups. Clinical and radiographic evaluations were performed at 6 months according to clinical signs and symptoms and radiographic sings using Periapical Index (PAI). Besides, temporary restorations were evaluated according to the of Ryge/Modified USPHS criteria. Following this evaluation, on the SW group, the cavities was re-entered and selective removal was applied up to firm dentin and pulp-capping were applied as mentioned above. In OneS group, temporary restoration was reduced as a base. All of the cavities were permanently restored with resin composite. Whole procedure was completed at one centre by a specialist, and control sessions was performed two experienced experts. Participants and experts were blinded in this study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Caries, Dental Pulp Exposure
    Keywords
    Selective Caries Removal, Deep Dentin Lesion, Permanent Teeth, Stepwise and One Step Excavation Technique

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SW
    Arm Type
    Experimental
    Arm Description
    stepwise excavation
    Arm Title
    OneS
    Arm Type
    Experimental
    Arm Description
    one step excavation
    Intervention Type
    Procedure
    Intervention Name(s)
    Stepwise Excavation
    Intervention Description
    stepwise excavation includes selective caries removal to soft dentine on pulpal wall in the first stage of the excavation and after six months, the second stage of intervention includes re-entring the cavities and wall selective removal to firm dentine on pulpal wall.
    Intervention Type
    Procedure
    Intervention Name(s)
    One Step Excavation
    Intervention Description
    *one step excavations is completed in the first stage via performing selective removal to soft dentine on pulpal wall of the cavities.
    Primary Outcome Measure Information:
    Title
    Pulpal Success Assessment
    Description
    Presence of vitality in treated tooth with positive response to electrical and thermal stimuli, no history of spontaneous pain and no response to percussion and pain (sensitivity) sign in palpation
    Time Frame
    a 6-month periods
    Title
    Health Status of Periapical Tissue
    Description
    According to Orstavik' Periapical Index (PAI), Periapical Index score scale are 1to 5 : scoring with PAI 1 or PAI 2 refer to healthy tooth but PAI 3, PAI 4 and PAI 5 as worse outcome for periapical tissue that sing of periapical tissue damage
    Time Frame
    a 6-month periods

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Molar teeth with primary caries lesion prolonged of 75 percentage or more of dentin radiographically1 Existence of vitality with positive response to electrical pulp test and cold test No history of spontaneous pain on the teeth No sign of pain on percussion and palpation (sensitivity) Exclusion Criteria: Individuals with the systemic disease who require hospitalization (oncological treatment, transplantation patients) Patients with uncontrolled hyperglycaemia or using insulin Patients with pregnancy/suspected Observation of radiolucency in the apex of the relevant tooth (PAI> 2) Secondary decayed teeth
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tijen Pamir, Ph.D
    Organizational Affiliation
    Ege University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27099357
    Citation
    Innes NP, Frencken JE, Bjorndal L, Maltz M, Manton DJ, Ricketts D, Van Landuyt K, Banerjee A, Campus G, Domejean S, Fontana M, Leal S, Lo E, Machiulskiene V, Schulte A, Splieth C, Zandona A, Schwendicke F. Managing Carious Lesions: Consensus Recommendations on Terminology. Adv Dent Res. 2016 May;28(2):49-57. doi: 10.1177/0022034516639276.
    Results Reference
    background
    PubMed Identifier
    20572864
    Citation
    Bjorndal L, Reit C, Bruun G, Markvart M, Kjaeldgaard M, Nasman P, Thordrup M, Dige I, Nyvad B, Fransson H, Lager A, Ericson D, Petersson K, Olsson J, Santimano EM, Wennstrom A, Winkel P, Gluud C. Treatment of deep caries lesions in adults: randomized clinical trials comparing stepwise vs. direct complete excavation, and direct pulp capping vs. partial pulpotomy. Eur J Oral Sci. 2010 Jun;118(3):290-7. doi: 10.1111/j.1600-0722.2010.00731.x.
    Results Reference
    background
    PubMed Identifier
    23207420
    Citation
    Maltz M, Jardim JJ, Mestrinho HD, Yamaguti PM, Podesta K, Moura MS, de Paula LM. Partial removal of carious dentine: a multicenter randomized controlled trial and 18-month follow-up results. Caries Res. 2013;47(2):103-9. doi: 10.1159/000344013. Epub 2012 Nov 28.
    Results Reference
    background
    PubMed Identifier
    20971154
    Citation
    Hayashi M, Fujitani M, Yamaki C, Momoi Y. Ways of enhancing pulp preservation by stepwise excavation--a systematic review. J Dent. 2011 Feb;39(2):95-107. doi: 10.1016/j.jdent.2010.10.012. Epub 2010 Dec 3.
    Results Reference
    background

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    Stepwise and One Step Techniques In Deep Dentin Lesion

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