Effect of Apical Patency on Success of Root Canal Treatment in Non Vital Teeth
Primary Purpose
Apical Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Apical patency
Sponsored by
About this trial
This is an interventional treatment trial for Apical Periodontitis focused on measuring Apical Patency, Root Canal Treatment
Eligibility Criteria
Inclusion Criteria:
- Mature permanent mandibular first molars
- Diagnosis of pulp necrosis, as confirmed by negative response to cold and electrical tests
- Radiographic evidence of apical periodontitis (minimum size ≥ 2.0 × 2.0 mm)
- Probing depth < 4mm
Exclusion Criteria:
- Non willingness to participate in study
- younger than 18 years of age
- Pregnant, diabetic or immunocompromised
- Prior endodontic treatment of the same tooth
- History of antibiotic use in past one month or requiring antibiotic pre-medication
- unrestorable teeth, fractured or perforated roots, grade 3 mobility
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Patency Group
Non Patency Group
Arm Description
apical patency was maintained during chemomechanical preparation
Apical patency was not maintained during chemomechanical preparation
Outcomes
Primary Outcome Measures
Change in periapical radiolucency
The change observed in periapical radiolucency at the 12-month follow-up visit was used to assess the success of the treatment
Secondary Outcome Measures
Clinical success
Absence of pain and tenderness to percussion/palpation, the absence of sinus or any associated soft-tissue swelling, tooth mobility of grade 1 or less, and no deterioration in periodontal probing depth as compared with baseline measurements
Full Information
NCT ID
NCT03454815
First Posted
February 19, 2018
Last Updated
March 4, 2018
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
1. Study Identification
Unique Protocol Identification Number
NCT03454815
Brief Title
Effect of Apical Patency on Success of Root Canal Treatment in Non Vital Teeth
Official Title
Effect of Apical Patency on Success of Primary Non-surgical Root Canal Treatment in Non Vital Teeth - a Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2013 (Actual)
Primary Completion Date
November 28, 2013 (Actual)
Study Completion Date
November 30, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Postgraduate Institute of Dental Sciences Rohtak
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Maintaining Apical patency during root canal treatment is a widely followed methodology in modern endodontic treatment protocols. It involves passing of a small #08 or #10 K file through the apical foramen during root canal shaping without widening it. it is done to keep the foramen and apical thirds of root canal free of debris. proponents of the procedure claim it to improve irrigation; provide better tactile feedback; reduce the chances of procedural errors; reduce transportation and reduce pain following root canal procedures. however, there is no clinical trial which specifically evaluates the effect of apical patency on outcome of root canal procedure. hence this study was designed to evaluate the effect of apical patency on outcome of root canal treatment.
Detailed Description
AIM:
To assess the role of maintaining Apical Patency on success of primary Non-Surgical Root Canal Treatment (NSRCT) in Non-Vital teeth.
To evaluate the incidence of post-operative complications such as pain, flare-up etc with and without maintaining apical patency.
Study subjects were recruited from the pool of patients referred for the initial non-surgical root canal treatment to the post graduate department Of Conservative Dentistry & Endodontics at PGIDS, Rohtak (Haryana). Patients requiring Root Canal Treatment following the diagnosis pulpal necrosis in mature mandibular first molar were selected for the study.
Clinical procedure:
Subjects were randomly allocated to one of the two study groups (patency or non-patency). It was ensured that neither the patient, nor the primary investigator was aware of the treatment protocol before completing the consent process. After administration of local anesthesia, rubber dam isolation of the involved tooth was done. Caries excavation was done and access cavity prepared using carbide burs in high speed handpiece with copious irrigation. Debridement of the pulp chamber was done and all canal orifices identified. Working length was obtained with the help of electronic apex locator (Root ZX) and confirmed radiographically. ProTaper S1 and Sx were used to flare coronal thirds and WL was reconfirmed with apex locator. Hand files No. 10, 15 and 20 were used till working length (WL) to prepare a smooth reproducible glide path. ProTaper S1 and S2 were used till WL, followed by the use of ProTaper finishing files (F1/F2/F3) to prepare the canal to desired size as determined by the operator. Copious irrigation with 3% Sodium Hypochlorite was carried out throughout the procedure with the use of 27-gauge side vented needle.
In patency group, a #10 K- file was passed 1mm beyond the WL between each instrument change, while in non-patency group it was carried till the WL. In patency group, a final radiograph was taken after completion of preparation, with a #10 file placed 1mm beyond the WL to confirm patency.
After enlargement, the canals were irrigated with 5ml 17% EDTA for 1 min followed by irrigation with 5ml 3% NaOCl. Canals were dried with absorbent paper points and filled with a paste made by mixing Calcium hydroxide powder with 2% Chlorhexidine liquid; and the access cavity restored with intermediate restorative material (IRM). The patient was recalled after 1 week. At the next appointment, the paste was removed with H- files and copious irrigation with 3% NaOCl. Canals were examined under operating microscpe. A final rinse of 5ml 17% EDTA and 5ml 3% NaOCl was done and canals dried with paper points. Canals were obturated with the GuttaPercha and Zinc Oxide- Eugenol based sealer. After obturation, the cavity was restored with Silver Amalgam/Composite/Full coverage crown. Immediate post-operative radiograph was then taken using preset exposure parameters with Rinn paralleling device; and processed manually. Follow up clinical and radiographic examination was carried out every 3 months, till a 12 month period.
Data Gathering Details:
Preoperative and intraoperative data were obtained from patient records. Diagnostic and treatment information was meticulously recorded on a custom designed endodontic treatment form by the operator. Diagnostic and treatment details for each patient were extracted from the records by the principal investigator.
Assessment of treatment outcome:
Treatment outcome was judged on the basis of clinical and radiographic findings recorded at the follow up visit and comparison of the radiographs obtained at post obturation and the follow-up visit
Radiographic success:
Change in Periapical Index (PAI) scores (Orstaviket 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
Normal periapical structures
Small changes in bone structure
Changes in bone structure with some mineral loss
Periodontitis with well-defined radiolucent area
Severe periodontitis with exacerbating features
Three experienced observers with no knowledge of the treatment protocol independently examined immediate post obturation and follow-up radiographs, mounted side by side, under controlled conditions. The treatment was considered successful only when both clinical and radiographic criteria were met. In multirooted teeth, the worst outcome by root decided the overall outcome for the tooth. In the event of disagreement, the three observers met to discuss their findings and came to an agreement. In the absence of unanimity, the majority decision was taken.
Clinical Success:
Absence of pain and tenderness to palpation/ percussion, absence of sinus or any associated soft tissue swelling, tooth mobility of grade-I or less, and no deterioration in periodontal probing depth as compared with baseline measurements comprised the criteria for clinical success.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apical Periodontitis
Keywords
Apical Patency, Root Canal Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patency Group
Arm Type
Experimental
Arm Description
apical patency was maintained during chemomechanical preparation
Arm Title
Non Patency Group
Arm Type
No Intervention
Arm Description
Apical patency was not maintained during chemomechanical preparation
Intervention Type
Procedure
Intervention Name(s)
Apical patency
Intervention Description
Apical patency was maintained by passing a #10 K file 1 mm beyond working length between every instrument change while doing chemomechanical preparation
Primary Outcome Measure Information:
Title
Change in periapical radiolucency
Description
The change observed in periapical radiolucency at the 12-month follow-up visit was used to assess the success of the treatment
Time Frame
Baseline to 12-month
Secondary Outcome Measure Information:
Title
Clinical success
Description
Absence of pain and tenderness to percussion/palpation, the absence of sinus or any associated soft-tissue swelling, tooth mobility of grade 1 or less, and no deterioration in periodontal probing depth as compared with baseline measurements
Time Frame
Baseline to 12-month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mature permanent mandibular first molars
Diagnosis of pulp necrosis, as confirmed by negative response to cold and electrical tests
Radiographic evidence of apical periodontitis (minimum size ≥ 2.0 × 2.0 mm)
Probing depth < 4mm
Exclusion Criteria:
Non willingness to participate in study
younger than 18 years of age
Pregnant, diabetic or immunocompromised
Prior endodontic treatment of the same tooth
History of antibiotic use in past one month or requiring antibiotic pre-medication
unrestorable teeth, fractured or perforated roots, grade 3 mobility
12. IPD Sharing Statement
Learn more about this trial
Effect of Apical Patency on Success of Root Canal Treatment in Non Vital Teeth
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