Effect of Different Instrumentation Technique on Endodontic Outcome

NCT03278054 | Completed DMC

• 1 other identifier: seema
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aim: To evaluate and compare the outcome of primary endodontic treatment following use of different instrumentation techniques. Materials and methods: Study subjects were recruited from the pool of patients referred for the non-surgical root canal treatment in the Department of Conservative Dentistry \& Endodontics at PGIDS, Rohtak (Haryana). The study population comprised of patients requiring primary root canal treatment following the diagnosis of pulpal necrosis with chronic apical periodontitis in mature mandibular first and second molars. Subjects were allocated to one of the three study groups: manual instrumentation, ProTaper instrumentation and Hybrid instrumentation.

Conditions

Apical Periodontitis

Keywords

apical periodontitis; hybrid; ProTaper; rotary

Outcome Measures

Primary Outcomes (2)

• Radiographic success

  Periapical radiolucency was graded as Periapical Index (PAI) and scores less than 3 were grded as success

  till 12 month period

• Clinical success

  Absence of pain tenderness sinus or swelling was graded as clinical success

  12 months

Secondary Outcomes (1)

• Pain intensity

  every 24 hours for 7 days

Study Arms (3)

Manual group

ACTIVE COMPARATOR

Root Canal Treatment with hand instruments:Root canal treatment was done with instrumentation using manual K files.

Other: Root Canal Treatment with hand instruments

ProTaper group

ACTIVE COMPARATOR

Root canal treatment with Protaper instruments:Root canal treatment was done using ProTaper rotary files S1, S2, F1, and F2.

Other: Root canal treatment with Protaper instruments

Hybrid group

ACTIVE COMPARATOR

Root canal treatment with hybrid instrumentation:Root canal treatment was carried out using ProTaper and Hyflex CM files.

Other: Root canal treatment with hybrid instrumentation

Interventions

Root Canal Treatment with hand instruments OTHER

Root canal treatment was performed with K files.

Manual group

Root canal treatment with Protaper instruments OTHER

Root canals were enlarged with S1 S2 F1F2 F2 Protaper instruments

ProTaper group

Root canal treatment with hybrid instrumentation OTHER

Root canal were enlarged with combination of a combination of ProTaper Universal instruments to shape the coronal and middle thirds and Hyflex CM to prepare the apical third

Hybrid group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient willing to participate in the study.
• Age greater than 18 years.
• No history of antibiotic use prior to treatment.
• Mature permanent mandibular molar having apical periodontitis requiring primary root canal treatment.
• There must be a radiographic evidence of periapical radiolucency 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.

You may not qualify if:

• Root canal retreatment.
• Failure to obtain authorization from patients.
• The presence of a difficult canal anatomy, internal or external resorption and immature teeth.
• Accident or complication during treatment like calcified canals, inability to achieve apical patency in any canals.
• Immuno-compromised, diabetic, pregnant and hypertensive patients.
• Periodontally compromised teeth.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: September 11, 2017
• Study Start: May 1, 2015
• Primary Completion: November 30, 2015
• Study Completion: October 30, 2016
• Last Updated: September 11, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share