Clinical Trial: Effect of Passive Ultrasonic Irrigation on Success of Primary Endodontic Treatment

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effect of Passive Ultrasonic Irrigation on Success of Primary Endodontic Treatment

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.


Detailed Summary:

Title: Effect of passive ultrasonic irrigation on success of primary endodontic treatment

Introduction:

It is well established that apical periodontitis is caused due to microbial invasion of root canal space. It is an inflammatory disease process comprising host responses to infection of the root canal system of the affected tooth. So, it becomes important to render the root canals free of microorganisms and pathological debris to treat apical periodontitis. Mechanical instrumentation plays an important role in removing microorganisms from the root canal system but it is incapable of rendering canal completely free of bacteria. The intricacies of the root canal system such as fins, isthmi, apical ramifications hinder its complete debridement as these areas are inaccessible to mechanical instrumentation. These complexities continue to harbour bacteria, necrotic tissue and debris and results in persistent periapical inflammation. Thus adjunctive use of root canal irrigant becomes important. Mechanical cleaning of root canals aided by antimicrobial irrigation, thus, are two key elements that help in reducing the bacterial load of root canal and treating apical periodontitis. Irrigation forms an integral part of chemomechanical preparation by facilitating the removal of bacteria, debris and necrotic tissue, especially from areas beyond the reach of root canal instruments. Sodium hypochlorite is recommended as the main irrigant during root canal treatment because of its antimicrobial efficacy as well as its tissue-dissolving capacity but its effectiveness in root canal depends on the irrigant's penetration along the full length of the canal and on irrigant exchange. Although conventional syringe delivery is a well accepted technique of irrigation but it delivers solutions no more than 0-1.1 mm beyond the needle tip thereby lim
Sponsor: Postgraduate Institute of Dental Sciences Rohtak

Current Primary Outcome: Periapical Index score [ Time Frame: 1 year ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome: Postoperative pain [ Time Frame: 6 hours-7 days ]

Visual analog scale (0-100mm) was used to evaluate pain levels. At the end of first appointment, all the patients were instructed to record the level of pain at 6 hours, 12 hours, 18 hours, 24 hours, 2 days, 3 days, 4 days, 5 days, and 6 days on the VAS pain score charts provided after the treatment.


Original Secondary Outcome: Same as current

Information By: Postgraduate Institute of Dental Sciences Rohtak

Dates:
Date Received: December 10, 2015
Date Started: May 2014
Date Completion:
Last Updated: December 11, 2015
Last Verified: December 2015