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NCT Number: NCT03397875

Effect of Various Sealers on Healing of Teeth With Apical Periodontitis

This study will compare the effect of three different sealers on healing of teeth with apical periodontitis after primary root canal treatment.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

About this study

Various sealers with different chemical composition and properties are available but it is yet not clear if one sealer is superior to other in terms of healing of apical periodontitis.

Three different groups of sealers will be used- a zinc oxide based sealer, an epoxy resin based sealer and a bioactive silicone based sealer. Mature mandibular permanent molar with the diagnosis of apical periodontitis (as confirmed clinically & by periapical radiograph) will be chosen for the study. Primary non surgical root canal treatment will be performed. The sealer will be randomly selected just before obturation of root canals. The patient will be allotted to one of the three groups.

  • Group I: Zinc oxide eugenol sealer group. The material will be mixed according to manufacturer instructions and applied to canals using a lentulospiral and the obturation will be performed.
  • Group II: Epoxy resin based sealer group. The material will be mixed according to the manufacturer's instructions and obturation will be done.
  • Group III: Bioactive silicone based sealer: The material will be used according to the manufacturer's instruction and obturation will be performed

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

The inclusion criteria of the study will include:

  • Patient willing to participate in the study.
  • Age >18 years.
  • No history of antibiotic use within the past month or requiring antibiotic premedication
  • No history of prior analgesic use during past 24 hrs.
  • Mature permanent mandibular molar having apical periodontitis requiring primary root canal treatment.
  • There must be a radiographic evidence of periapical radiolucency (minimum size 2mmx2mm) and a diagnosis of pulpal necrosis, as confirmed by negative response to cold and electrical tests; and absence of bleeding on entering the pulp chamber

Exclusion criteria

  • Re-treatment
  • Unwillingness of patients
  • The presence of a difficult canal anatomy (root canals with an extreme curvature ≥30 deg), internal or external resorption and immature teeth.
  • Accident or complication during treatment (calcified canals ,inability to achieve apical patency in any canals) Immuno-compromised, diabetic, pregnant and hypertensive patients.
  • Teeth that are peridontally compromised

Treatment and study plan

Zinc oxide based sealer

Procedure

After root canal treatment obturation will be done using zinc oxide eugenol based sealer.

Epoxy resin based sealer

Procedure

After root canal treatment obturation will be done using epoxy resin based sealer.

Bioactive silicone based sealer

Procedure

Other names: After root canal treatment obturation will be done using bioactive silicone based sealer.

Primary outcomes

  1. Radiographic success

    Time frame: 12 months

    Change in apical bone density will be measured by Periapical Index (PAI) score. PAI score equal to or less than 2 will be categorized as success.

  2. Clinical success

    Time frame: 12 months

    Absence of pain, sinus tract, swelling and mobility.

Sponsors and collaborators

Lead sponsor

Postgraduate Institute of Dental Sciences Rohtak

Other

Registry information

Official study title

Effect of Various Sealers on Healing of Teeth With Apical Periodontitis: A Clinical Study

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 12, 2018
Registry last updated
Oct 17, 2018

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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