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

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.

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Key information

Conditions

Irreversible Pulpitis Apical Periodontitis Jaw Diseases Mouth Diseases Periapical Diseases Periapical Periodontitis Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

12 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Root canal sealer

Procedure

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 outcomes

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".

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Hui Chen

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Dec 5, 2016
Registry last updated: Dec 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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