Effect of Passive Ultrasonic Irrigation on Success of Primary Endodontic Treatment

NCT02632513 | Completed DMC

• 1 other identifier: PGIDS/IEC/2014/120
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study was to compare the success after endodontic treatment performed with or without continuous ultrasonic irrigation. 70 Mandibular molars with diagnosis of pulpal necrosis and with periapical radiolucency were randomly assigned into two treatment groups- continuous ultrasonic irrigation (CUI) and syringe irrigation (SI). Standard nonsurgical endodontic treatment was performed on both groups under rubber dam isolation with 0.02 taper ISO stainless steel hand files using step back technique. In both groups, 5 ml of 5.25% sodium hypochlorite was used as irrigant after each instrument. After root canal instrumentation, canals were irrigated with 5 ml of 17% EDTA solution for 1 minute. In SI group, canals were flushed with 15ml of 5.25% sodium hypochlorite using a 27 gauge needle while final irrigant was delivered using a continuous ultrasonic irrigation device in CUI group. An inter-appointment dressing of calcium hydroxide was given and patient was recalled after one week and canals were obturated with the Gutta Percha. Immediate postoperative radiograph was then taken, followed by radiographs at 3, 6, 9 and 12 months.

Conditions

Periapical Periodontitis

Keywords

continuous ultrasonic irrigation, syringe irrigation

Outcome Measures

Primary Outcomes (1)

• Periapical Index score

  Change in Periapical Index (PAI) scores (Orstavik et al) observed at 12-months was noted. Scoring of each tooth was done according to the following five point scale (PAI): PAI Score Description of radiographic findings 1. Normal periapical structures 2. Small changes in bone structure 3. Changes in bone structure with some mineral loss 4. Periodontitis with well-defined radiolucent area 5. Severe periodontitis with exacerbating features

  1 year

Secondary Outcomes (1)

• Postoperative pain

  6 hours-7 days

Study Arms (2)

continuous ultrasonic irrigation

EXPERIMENTAL

In continuous ultrasonic irrigation group, Proultra PiezoFlow (Dentsply Tulsa Dental Specialties, Tulsa,OK) was used for the activation of the irrigating solution according to manufacturer's recommendations.

Device: Proultra PiezoFlow (Dentsply Tulsa Dental Specialties)

Syringe irrigation

NO INTERVENTION

In the syringe irrigation group, irrigation was done using 27 gauge syringe.

Interventions

Proultra PiezoFlow (Dentsply Tulsa Dental Specialties) DEVICE

In continuous ultrasonic irrigation group, Proultra PiezoFlow (Dentsply Tulsa Dental Specialties, Tulsa,OK) was used for the activation of the irrigating solution according to manufacturer's recommendations.

continuous ultrasonic irrigation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient willingness to participate in the study
• Mature permanent mandibular molar requiring primary root canal treatment
• Patient's age greater than 18 years
• There must be radiographic evidence of periapical radiolucency (minimum size ≥ 2.0 × 2.0 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

You may not qualify if:

• Patients who did not provide authorization for participation in the study
• Positive history of antibiotic use within past one month of the treatment
• Positive history of analgesic intake within the past 24 hours
• Patients who were pregnant, diabetic, immunocompromised, had serious medical illness or required antibiotic premedication
• Patients with pockets ≥4mm or having marginal of furcal bone loss due to periodontitis
• Previously accessed teeth and/or with procedural errors
• Unrestorable tooth, fractured/ perforated roo ts, inflammatory root resorption

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: December 10, 2015
• First Posted: December 16, 2015
• Study Start: May 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 16, 2015

Record last verified: 2015-12