Clinical Trial: Evaluation of iRoot SP as Root Canal Sealer: A Clinical Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 1-year Evaluation of iRoot SP as a Root Canal Sealer Compare to AH Plus Sealer: A Prospective Clinical Study

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.

Detailed Summary:
Sponsor: Hui Chen

Current Primary Outcome: Radiographical assessments [ Time Frame: 1 year after root canal therapy ]

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".


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinical assessments [ Time Frame: 1 year after root canal therapy ]
    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 [ Time Frame: 1 week after root canal therapy ]
    Pain was evaluated by using a visual analogue scale (VAS) made of a 10 cm line, where 0 = no pain and 10 = unbearable pain.


Original Secondary Outcome: Same as current

Information By: The Dental Hospital of Zhejiang University School of Medicine

Dates:
Date Received: November 27, 2016
Date Started: January 2014
Date Completion:
Last Updated: November 30, 2016
Last Verified: November 2016