Back to resultsEvaluation of iRoot SP as Root Canal Sealer: A Clinical Study
Primary Purpose
Irreversible Pulpitis, Apical Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Root canal sealer
Sponsored by
About this trial
This is an interventional treatment trial for Irreversible Pulpitis
Eligibility Criteria
Inclusion Criteria:
Subjects were required to:
- have a mature tooth with closed apices;
- have one single or multi-rooted tooth with irreversible pulpitis, pulp necrosis or apical periodontitis;
- be prepared to appear for follow-up and
- sign informed consent form.
Exclusion Criteria:
Subjects with:
- moderate or severe marginal periodontitis;
- internal or external root resorption in periapical radiograph;
- active systemic disease;
- physical or mental disability,
- pregnant or lactating
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
iRoot SP sealer
AH Plus sealer
Arm Description
iRoot SP sealer was used as root canal sealer in root canal obturation.
AH Plus sealer was used as a gold standard to be compared with iRoot SP sealer in root canal obturation.
Outcomes
Primary Outcome Measures
Radiographical assessments
The periapical status was assessed in the radiographs.Teeth with complete restitution of the periodontal contours were judged as "healed". Teeth with a clearly decreased size of the periapical radiolucency were judged as "healing". Teeth with unchanged, increased, or new periapical radiolucency were judged as "failed".
Secondary Outcome Measures
Clinical assessments
The root filled tooth was considered clinically successful if there was absence of clinical sign or symptom such as spontaneous pain, sensitivity to percussion or palpation, abnormal mobility, signs of pathology like abscess or sinus tract.
Postoperative Pain Evaluation
Pain was evaluated by using a visual analogue scale (VAS) made of a 10 cm line, where 0 = no pain and 10 = unbearable pain.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02981693
Brief Title
Evaluation of iRoot SP as Root Canal Sealer: A Clinical Study
Official Title
1-year Evaluation of iRoot SP as a Root Canal Sealer Compare to AH Plus Sealer: A Prospective Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hui Chen
4. Oversight
5. Study Description
Brief Summary
The purpose of this study was to evaluate the clinical and radiological outcomes of iRoot SP as a root canal sealer in comparison with AH Plus sealer within 1-year follow up.Patients needing root canal treatment were enrolled and allotted into either iRoot SP group or AH Plus arm randomly. After root canal shaping and cleaning, the teeth were obturated according to their arms. Assessment of postoperative pain was done 1 week after root canal obturation using visual analog scale. After 1-year follow-up, clinical and radiographic evaluations were carried out. Statistical analysis at P < 0.05 was conducted to measure difference between the arms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irreversible Pulpitis, Apical Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
283 (Actual)
8. Arms, Groups, and Interventions
Arm Title
iRoot SP sealer
Arm Type
Experimental
Arm Description
iRoot SP sealer was used as root canal sealer in root canal obturation.
Arm Title
AH Plus sealer
Arm Type
Active Comparator
Arm Description
AH Plus sealer was used as a gold standard to be compared with iRoot SP sealer in root canal obturation.
Intervention Type
Procedure
Intervention Name(s)
Root canal sealer
Intervention Description
Patients who required root canal therapy were enrolled and allotted into either iRoot SP arm or AH Plus arm randomly.For Test Arm: iRoot SP was used as a sealer. Obturation was performed with Gutta-percha cones and root canal sealer by continuous-wave condensation technique. For Control Arm: AH Plus was used as root canal sealer. The same steps were followed for obturation as in Test Arm.
Primary Outcome Measure Information:
Title
Radiographical assessments
Description
The periapical status was assessed in the radiographs.Teeth with complete restitution of the periodontal contours were judged as "healed". Teeth with a clearly decreased size of the periapical radiolucency were judged as "healing". Teeth with unchanged, increased, or new periapical radiolucency were judged as "failed".
Time Frame
1 year after root canal therapy
Secondary Outcome Measure Information:
Title
Clinical assessments
Description
The root filled tooth was considered clinically successful if there was absence of clinical sign or symptom such as spontaneous pain, sensitivity to percussion or palpation, abnormal mobility, signs of pathology like abscess or sinus tract.
Time Frame
1 year after root canal therapy
Title
Postoperative Pain Evaluation
Description
Pain was evaluated by using a visual analogue scale (VAS) made of a 10 cm line, where 0 = no pain and 10 = unbearable pain.
Time Frame
1 week after root canal therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects were required to:
have a mature tooth with closed apices;
have one single or multi-rooted tooth with irreversible pulpitis, pulp necrosis or apical periodontitis;
be prepared to appear for follow-up and
sign informed consent form.
Exclusion Criteria:
Subjects with:
moderate or severe marginal periodontitis;
internal or external root resorption in periapical radiograph;
active systemic disease;
physical or mental disability,
pregnant or lactating
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Chen
Organizational Affiliation
Affiliated Hospital of Stomatology, College of Medicine, Zhejiang University
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Evaluation of iRoot SP as Root Canal Sealer: A Clinical Study
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