Healing Outcome of Root Canal Therapy in Maxillary Molars With DOM

NCT ID: NCT04358861

Last Updated: 2020-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2020-01-01

Brief Summary

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.

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.

Conditions

Periapical Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental group

Nonsurgical Root canal therapy was performed using dental operating microscope in the experimental group.

Group Type: EXPERIMENTAL

Nonsurgical Root canal therapy

Intervention Type: 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

Intervention Type: DEVICE

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

Control group

Nonsurgical Root canal therapy was performed without any magnification aid in control group.

Group Type: ACTIVE_COMPARATOR

Nonsurgical Root canal therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Dental operating microscope

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, India

Countries

India

Other Identifiers

Neelam

Identifier Type: -

Identifier Source: org_study_id