Effect of Different Instrumentation Technique on Endodontic Outcome
Primary Purpose
Apical Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Root Canal Treatment with hand instruments
Root canal treatment with Protaper instruments
Root canal treatment with hybrid instrumentation
Sponsored by
About this trial
This is an interventional treatment trial for Apical Periodontitis focused on measuring apical periodontitis, hybrid, ProTaper, rotary
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Manual group
ProTaper group
Hybrid group
Arm Description
Root Canal Treatment with hand instruments:Root canal treatment was done with instrumentation using manual K files.
Root canal treatment with Protaper instruments:Root canal treatment was done using ProTaper rotary files S1, S2, F1, and F2.
Root canal treatment with hybrid instrumentation:Root canal treatment was carried out using ProTaper and Hyflex CM files.
Outcomes
Primary Outcome Measures
Radiographic success
Periapical radiolucency was graded as Periapical Index (PAI) and scores less than 3 were grded as success
Clinical success
Absence of pain tenderness sinus or swelling was graded as clinical success
Secondary Outcome Measures
Pain intensity
Pain intensity before and after treatment was recorded using 0-100 mm VAS scale
Full Information
NCT ID
NCT03278054
First Posted
June 26, 2017
Last Updated
September 8, 2017
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
1. Study Identification
Unique Protocol Identification Number
NCT03278054
Brief Title
Effect of Different Instrumentation Technique on Endodontic Outcome
Official Title
Effect of Different Instrumentation Technique on Outcome of Primary Non Surgical Endodontic Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 1, 2015 (Actual)
Primary Completion Date
November 30, 2015 (Actual)
Study Completion Date
October 30, 2016 (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
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.
Detailed Description
AIMS AND OBJECTIVES
The present study has been designed with the following aims and objective:
To evaluate the effect of manual / rotary/hybrid instrumentation techniques on success of primary non surgical root canal treatment in teeth with apical periodontitis.
To assess the incidence of postoperative pain in teeth treated with and without rotary instrumentation.
To compare manual, rotary and hybrid instrumentation techniques in terms of periapical healing in teeth with apical periodontitis.
METHODOLOGY
Prior to treatment a thorough clinical and radiological examination was carried out. A thorough history was taken from each patient. Prior informed consent was taken after explaining the procedure, risks and benefits.
Clinical procedure: A total of 90 patients (n=30 in each group) were included in the study. Mature mandibular permanent molar with diagnosis of apical periodontitis (as confirmed clinically & by periapical radiograph) were chosen for the study. Patients were randomly allocated into three groups :Group I- manual instrumentation, Group II -rotary instrumentation (ProTaper) and Group III -Rotary instrumentation (Hybrid ).
After administration of local anesthesia, rubber dam isolation of the involved tooth was done. Caries excavation was done and access cavity was prepared using carbide burs in high speed handpiece with copious irrigation.Debridement of the pulp chamber was done and all canal orifices were identified. Negotiation of canals was done. Working length was determined using root ZX apex locator and verified radiographically. Instrumentation was done as follows.
GROUP A: Manual instrumentation: Hand instrumentation with the stainless steel K files was performed using step back technique.
GROUP B: Rotary instrumentation (ProTaper files): The cleaning and shaping of the canals was completed in accordance with a crown down technique recommended by the manufacturer, using the following operative sequence. Canals were instrumented with ProTaper rotary instruments. Recapitulation was carried out with size 10 k file.
GROUP C: rotary instrumentation (Hybrid): Roots canals were shaped with a combination of two NiTi rotary systems: ProTaper Universal instruments were used to shape the coronal and middle thirds and Hyflex CM files to prepare the apical third.
After completion of canal instrumentation in all the groups, canals were irrigated with 5.0 mL of 17% ethylene-diamine-tetra acetic acid for 1 minute followed by a final irrigation with 5.0 mL of 5.25% sodium hypochlorite. Canals were then be dried with sterile paper points. A lentulo-spiral was used to fill all canals with a Calcium hydroxide paste and the access cavity to be restored with intermediate restorative material. The patient were recalled after 1 week. At the second appointment, the calcium hydroxide paste were removed by using circumferential filing with Hedstrom files and copious irrigation with 5.25% sodium hypochlorite followed by 5.0 mL of 17% ethylenediaminetetraacetic acid and a final rinse of 5.0 mL 5.25% sodium hypochlorite. Canals were dried with the help of absorbent paper points and obturated. After obturation, the cavity was permanently restored. Immediate post-operative radiograph was then taken using preset exposure parameters and processed manually.
FOLLOW UP
Follow up and clinical and radiographic examination was carried out at 3, 6, 9 & 12 month period.
Outcome variables
The primary outcome variables observed for the study was long term clinical and radiographic success rates.
The secondary outcome measure was the incidence of postoperative pain.
Radiographic success: Radiographic success (change in Periapical Index score) of the root canal therapy was drawn by comparing the pre-operative; 3 month, 6month, 9 month & 12-month follow up radiographs.
Clinical success: it was determined by
Absence of inter appointment flare ups and pain.
Absence of tenderness to palpation /percussion
Absence of sinus or any associated soft tissue swelling.
Tooth mobility of grade I or less.
No deterioration in periodontal pocket depth.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apical Periodontitis
Keywords
apical periodontitis, hybrid, ProTaper, rotary
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manual group
Arm Type
Active Comparator
Arm Description
Root Canal Treatment with hand instruments:Root canal treatment was done with instrumentation using manual K files.
Arm Title
ProTaper group
Arm Type
Active Comparator
Arm Description
Root canal treatment with Protaper instruments:Root canal treatment was done using ProTaper rotary files S1, S2, F1, and F2.
Arm Title
Hybrid group
Arm Type
Active Comparator
Arm Description
Root canal treatment with hybrid instrumentation:Root canal treatment was carried out using ProTaper and Hyflex CM files.
Intervention Type
Other
Intervention Name(s)
Root Canal Treatment with hand instruments
Intervention Description
Root canal treatment was performed with K files.
Intervention Type
Other
Intervention Name(s)
Root canal treatment with Protaper instruments
Intervention Description
Root canals were enlarged with S1 S2 F1F2 F2 Protaper instruments
Intervention Type
Other
Intervention Name(s)
Root canal treatment with hybrid instrumentation
Intervention Description
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
Primary Outcome Measure Information:
Title
Radiographic success
Description
Periapical radiolucency was graded as Periapical Index (PAI) and scores less than 3 were grded as success
Time Frame
till 12 month period
Title
Clinical success
Description
Absence of pain tenderness sinus or swelling was graded as clinical success
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Pain intensity
Description
Pain intensity before and after treatment was recorded using 0-100 mm VAS scale
Time Frame
every 24 hours for 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Different Instrumentation Technique on Endodontic Outcome
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