search
Back to results

Success Rate of Single Versus Two Visit Regenerative Treatment Protocol in Non Vital Mature Anterior Teeth

Primary Purpose

Pulp Necrosis, Periapical Lesion, Anterior Teeth

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Single visit pulp regeneration
Two visit pulp regeneration
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulp Necrosis focused on measuring Regeneration, mature teeth, regenerative procedures

Eligibility Criteria

15 Years - 35 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Single canal anterior tooth

    • Mature root
    • Non vital with radiographic evidence of periapical lesion
    • Periapical lesion of average size 2-5mm
    • Positive patient compliance for participation in the study.
    • Patients with good oral hygiene
    • Normal periodontal probing depth ≤ 3 mm

Exclusion Criteria:

  • Compromised remaining tooth structure that need post and core build up
  • Non restorable teeth
  • Vital teeth
  • Radiographic evidence of external or internal root resorption.
  • Roots showing fracture or ankylosis
  • Medically compromised patients
  • Pregnant women
  • Greater than grade I mobility or periodontal probing depth greater than 3mm
  • Immature tooth
  • Patients with pain, swelling or fistula tracts

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Single visit pulp regeneration

    Two visit pulp regeneration

    Arm Description

    Regenerative endodontic procedure not involving placement of intracanal medicament will be done in single visit

    Regenerative endodontic procedure involving placing intracanal medicament will be done in two visit

    Outcomes

    Primary Outcome Measures

    Change in Post operative pain: NRS
    absence of pain reported by the patient by numerical rate scale, the 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
    Change in swelling and/or sinus
    The presence of swelling or sinus will be reported by a binary question yes/no
    Periapical healing
    The existing periapical lesion will be measured by mm by CBCT before intiation of treatment and after one year

    Secondary Outcome Measures

    Antimicrobial effect
    intracanal bacterial count by culture method
    Sensitivity
    Tooth giving respond to electrical pulp tester
    Discoloration
    Recording tooth shade before and after treatment

    Full Information

    First Posted
    October 14, 2018
    Last Updated
    October 23, 2018
    Sponsor
    Cairo University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03717337
    Brief Title
    Success Rate of Single Versus Two Visit Regenerative Treatment Protocol in Non Vital Mature Anterior Teeth
    Official Title
    Evaluation of Success Rate of Non Vital Mature Anterior Teeth With Periapical Lesion Following Single Versus Two Visit Regenerative Treatment Protocol A Randomized Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2019 (Anticipated)
    Primary Completion Date
    September 1, 2020 (Anticipated)
    Study Completion Date
    December 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

    5. Study Description

    Brief Summary
    This study evaluates success rate of non vital mature anterior teeth with periapical lesion treated by regenerative endodontic protocol in single visit versus two visit technique. Patients are randomized into two groups where treatment will be done either in one visit including access, disinfection, placing platelet rich plasma as scaffold and restoration or two visit protocol involving access, disinfection and placing calcium hydroxide as intracanal medicament in first visit followed by a second visit after 3 weeks involving reopening of the tooth, removing intracanal medicament and placing platelet rich plasma as scaffold then restoration. Success rate is defined as absence of subjective signs and symptoms along with healing of periapical lesion
    Detailed Description
    Title: Evaluation of Success Rate of Non Vital Mature Anterior Teeth with Periapical Lesion Following Single versus Two Visit Regenerative Treatment Protocol (A Randomized Clinical Trial) Regenerative endodontics can be defined as biologically based procedures designed to replace damaged structures, including dentin and root structures, as well as cells of the pulp-dentin complex. The majority of endodontic patients are adults, thus the application of the tissue engineering concept to mature teeth could provide a biological treatment modality instead of the conventional one. In fact, several advantages were reported about regenerative procedures in well developed mature teeth. Reconstitution of the neurovascular system in root canals by pulp regeneration will provide pulp tissues with an immune system, which will function as the first line of defense against microbial challenge. Moreover, restoration of pulp dentine complex will protect the tooth during loading and mastication. Different treatment protocols for pulp regeneration were reported in the literature regarding irrigation (type, concentration and time), intracanal medication, pulpal space barrier, incorporation and lack of scaffolds (blood clot, PRP,PRF, collagen) as well as recall visits. Rationale for conducting the research and choice of comparators: Multiple visits protocol has been the commonly used technique in regenerative endodontic procedures. It involves the placement of intracanal medicaments between visits (calcium hydroxide and triple antibiotic paste) which have many drawbacks such as difficulty in removal, tooth discoloration, weakening of the root and tooth loss. Completing revascularization in one visit has many advantages. First, it reduces the chance of additional bacterial contamination of the space. Second, a single revascularization protocol may overcome the problem of poor patient compliance and reduce the number of appointments needed. Third, it can help to combat potential injury of the tooth and tooth discoloration Unfortunately, up till the moment it is not clear which protocol is the most effective. Thus randomized clinical trials are required to provide plausible answers to this question In the present research the recent single visit regenerative treatment for necrotic mature teeth will be compared to the conventionally used two visit one

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulp Necrosis, Periapical Lesion, Anterior Teeth
    Keywords
    Regeneration, mature teeth, regenerative procedures

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The design of this randomized clinical trial is a parallel group two arms trial with 1:1 allocation ratio
    Masking
    Outcomes Assessor
    Masking Description
    single
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Single visit pulp regeneration
    Arm Type
    Experimental
    Arm Description
    Regenerative endodontic procedure not involving placement of intracanal medicament will be done in single visit
    Arm Title
    Two visit pulp regeneration
    Arm Type
    Active Comparator
    Arm Description
    Regenerative endodontic procedure involving placing intracanal medicament will be done in two visit
    Intervention Type
    Procedure
    Intervention Name(s)
    Single visit pulp regeneration
    Intervention Description
    Access cavity, disinfection, preparing and injecting platelet rich plasma, and restoring the tooth all done in one visit.
    Intervention Type
    Procedure
    Intervention Name(s)
    Two visit pulp regeneration
    Intervention Description
    first visit : access, disinfection and placing calcium hydroxide as intracanal medicament second visit: re opening of tooth, preparing and injecting platelet rich plasma and restoring the tooth.
    Primary Outcome Measure Information:
    Title
    Change in Post operative pain: NRS
    Description
    absence of pain reported by the patient by numerical rate scale, the 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
    Time Frame
    3, 6, 9 and 12 months
    Title
    Change in swelling and/or sinus
    Description
    The presence of swelling or sinus will be reported by a binary question yes/no
    Time Frame
    3,6,9,12 months
    Title
    Periapical healing
    Description
    The existing periapical lesion will be measured by mm by CBCT before intiation of treatment and after one year
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Antimicrobial effect
    Description
    intracanal bacterial count by culture method
    Time Frame
    before and after complete disinfection either in the same visit or after 3 weeks from the second visit
    Title
    Sensitivity
    Description
    Tooth giving respond to electrical pulp tester
    Time Frame
    3, 6, 9 and 12 months
    Title
    Discoloration
    Description
    Recording tooth shade before and after treatment
    Time Frame
    3, 6, 9 and 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Single canal anterior tooth Mature root Non vital with radiographic evidence of periapical lesion Periapical lesion of average size 2-5mm Positive patient compliance for participation in the study. Patients with good oral hygiene Normal periodontal probing depth ≤ 3 mm Exclusion Criteria: Compromised remaining tooth structure that need post and core build up Non restorable teeth Vital teeth Radiographic evidence of external or internal root resorption. Roots showing fracture or ankylosis Medically compromised patients Pregnant women Greater than grade I mobility or periodontal probing depth greater than 3mm Immature tooth Patients with pain, swelling or fistula tracts

    12. IPD Sharing Statement

    Learn more about this trial

    Success Rate of Single Versus Two Visit Regenerative Treatment Protocol in Non Vital Mature Anterior Teeth

    We'll reach out to this number within 24 hrs