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Completed

NCT Number: NCT04358861

Healing Outcome of Root Canal Therapy in Maxillary Molars With DOM

The aim of study was to evaluate the effect of dental operating microscope use on the healing outcome of non surgical endodontic treatment of maxillary molars.

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Key information

Age range

18 year and older

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

Prior to treatment a thorough clinical and radiological examination was carried out. A thorough history was taken from each patient and written informed consent was taken after explaining the procedure, risks and benefits. Mature maxillary first permanent molar with diagnosis of periapical periodontitis (as confirmed clinically & by periapical radiograph) was chosen for the study. Fifty participants were randomly assigned to either the dental operating microscope group or to control group (without using dental operating microscope) for the treatment.

After administration of local anesthesia and rubber dam isolation of the involved tooth ; access cavity was prepared using carbide bur and refined using ultrasonic tip in both groups. In both the groups similar protocol for irrigation, obturation and post operative restorations was followed. Immediate post-operative radiograph was taken using preset exposure parameters and follow up clinical and radiographic examination was carried at 12th month.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient willing to participate in the study
  • Age > 18 years
  • Maxillary permanent first molar having apical periodontitis requiring primary endodontic treatment
  • Radiographic evidence of periapical radiolucency (minimum size 2 mmx 2 mm) 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

  • Unwillingness of patient.
  • Retreatment cases
  • Presence of internal or external resorption ,root canal perforations during endodontic treatment and immature teeth.
  • Periodontally compromised teeth
  • Immunocompromised, diabetic, pregnant and hypertensive patients
  • Vertical root fractures
  • Teeth those are not suitable for rubber dam application

Treatment and study plan

Nonsurgical root canal therapy

Procedure

After administration of LA and rubber dam isolation, acess cavity was prepared using carbide burs. Working length was determined using root ZX apex locator and was verified radiographically. Canal preparation was done with protaper gold rotary instruments. 5ml of 5.25% NaOCl was used as irrigant. After instrumentation , the canals were irrigated with 5.0 ml of 17% EDTA for 1minute followed by irrigation with 5.0 ml of 5.25% NaOCl. Canals were dried with absorbent paper points, filled with calcium hydroxide paste and access cavity was restored with IRM.At the recall appointment ; after one week,paste removal, copious irrigation was done with 5.25% NaOCl and canals were dried with paper points. Canals were obturated with Gutta-Percha and ZOE based sealer.

Dental operating microscope

Device

Dental operating microscope; a high magnification and illumination device was used in experimental group for performing nonsurgical root canal therapy.

Primary outcomes

  1. Clinical and radiographic success

    Time frame: 12 months

    long term clinical and radiographic success measured in terms of reduction in size of periapical radiolucency on radiograph from baseline to 12 months using PAI score 1,2 as healing and more than 2 as non healing

Secondary outcomes

  1. Number of canals located in MB root

    Time frame: 12 months

    incidence of additional canals located in MB root

Sponsors and collaborators

Lead sponsor

Postgraduate Institute of Dental Sciences Rohtak

Other

Registry information

Official study title

Healing Outcome of Nonsurgical Root Canal Treatment in Maxillary Molars With Dental Operating Microscope : A Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2018
Study completion
2020
First posted
Apr 24, 2020
Registry last updated
Apr 24, 2020

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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