Healing Outcome of Root Canal Therapy in Maxillary Molars With DOM

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

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.

Study Overview

• Status: Completed
• Conditions: Periapical Periodontitis
• Intervention / Treatment: Procedure: Nonsurgical Root canal therapy; Device: Dental operating microscope

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • Post Graduate Institute of dental sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Nonsurgical Root canal therapy was performed using dental operating microscope in the experimental group.	Procedure: Nonsurgical Root canal therapy; 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.; Device: Dental operating microscope; Dental operating microscope; a high magnification and illumination device was used in experimental group for performing nonsurgical root canal therapy.
Active Comparator: Control group; Nonsurgical Root canal therapy was performed without any magnification aid in control group.	Procedure: Nonsurgical Root canal therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical and radiographic success	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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of canals located in MB root	incidence of additional canals located in MB root	12 months

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: April 17, 2020
• First Submitted That Met QC Criteria: April 22, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 22, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Dental Operating Microscope
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Jaw Diseases; Periapical Diseases; Periodontitis; Periapical Periodontitis
• Other Study ID Numbers: Neelam

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No