Effect of Sodium Hypochlorite Concentration on Success of Non-surgical Root Canal Treatment
Primary Purpose
Apical Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Root canal treatment with 5% NaOCl
Root canal treatment with 1% NaOCl
Sponsored by
About this trial
This is an interventional treatment trial for Apical Periodontitis
Eligibility Criteria
Inclusion Criteria:
- Patient willingness to participate in the study
- Mature permanent mandibular first and second molars requiring primary root canal treatment
- Diagnosis of pulpal necrosis, as confirmed by negative response to cold and electrical tests; and absence of bleeding on entering the pulp chamber
- Radiographic evidence of periapical radiolucency (minimum size ≥ 2.0 × 2.0 mm)
- Patient's age more than 18 years
Exclusion Criteria
- Positive history of antibiotic use within past one month of the treatment.
- Positive history of analgesic use within the past 3 days.
- Patients who are pregnant, diabetic, immunocompromised, had serious medical illness or required antibiotic premedication
- Patients with pockets ≥4mm or having marginal or furcal bone loss due to periodontitis
- Teeth that are not suitable for rubber dam isolation
- Previously accessed teeth and/or with procedural errors
- Unrestorable tooth, fractured/ perforated roots, inflammatory root resorption
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Root canal treatment with 5% NaOCl
Root canal treatment with 1% NaOCl
Arm Description
Root canal treatment with 5% NaOCl: 5 ml of 5% sodium hypochlorite was used during root canal treatment after each instrument change.After root canal instrumentation, canals irrigated with 5ml of 17% EDTA solution for 1 minute followed by final wash with 5ml of 5% sodium hypochlorite.
5 ml of 1% soium hypochlorite was used during root canal treatment after each instrument change.After root canal instrumentation, canals irrigated with 5ml of 17% EDTA solution for 1 minute followed by final wash with 5ml of 1% sodium hypochlorite.
Outcomes
Primary Outcome Measures
Radiographic success
Treatment outcome was judged on the basis of radiographic findings recorded at the follow up visit and comparison of the radiographs obtained at post obturation and the follow-up visit.Change in Periapical Index (PAI) scores observed at 12-months was noted and scoring of each tooth was done according to the PAI scores and score less than 3 were considered as success.
Clinical success
Absence of pain and tenderness to palpation/ percussion, absence of sinus or any associated soft tissue swelling, tooth mobility, and no deterioration in periodontal probing depth as compared with baseline measurements comprised the criteria for clinical success.
Secondary Outcome Measures
Pain intensity
Pain intensity before and after treatmemt was recorded by use of 10cm VAS with zero depicting no pain and 10 depicting maximum pain.Patient rate their pain intensity by making a mark somewhere on the line that represents their pain intensity and VAS was scored by measuring the distance from the "no pain" end of line.
Full Information
NCT ID
NCT03288467
First Posted
September 11, 2017
Last Updated
May 22, 2018
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
1. Study Identification
Unique Protocol Identification Number
NCT03288467
Brief Title
Effect of Sodium Hypochlorite Concentration on Success of Non-surgical Root Canal Treatment
Official Title
Effect of Sodium Hypochlorite Concentration on Success of Non-surgical Root Canal Treatment: A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
November 6, 2016 (Actual)
Primary Completion Date
November 30, 2017 (Actual)
Study Completion Date
November 30, 2017 (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
.There is no general agreement regarding the optimal concentration of sodium hypochlorite to be used in endodontic treatment.Therefore, this study aims to evaluate the effect of sodium hypochlorite concentration on the success of primary root canal treatment. 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.Patients were randomly allocated in either High concentration or Low concentration group.
Detailed Description
AIMS AND OBJECTIVES
To evaluate the success of primary endodontic treatment following use of 5% and 1% NaOCl in non-vital, posterior teeth.
To compare the success achieved following use of the two different concentrations of NaOCl.
To evaluate postoperative pain following use of 5% and 1% NaOCl.
MATERIALS AND METHODS: Mature mandibular first and second molars with diagnosis of pulp necrosis (as confirmed by negative response to cold and electric pulp testing), and having apical radiolucency were chosen for the study.The consenting subjects were allocated to one of the two study groups based on concentration of NaOCl used: 5% [high concentration (HC)] and 1% [low concentration (LC)].Using an equal proportion randomization allocation ratio, envelopes containing concealed assignment codes were assigned sequentially to eligible patients.It was ensured that neither the patient, nor the primary investigator was aware of the treatment protocol before beginning of the treatment procedure.
CLINICAL PROCEDURE:
2% lidocaine with 1/80000 epinephrine was used to achieve profound local anaesthesia.
After proper isolation with rubber dam, access cavity was made with a high speed handpiece and carbide bur.
Debridement of the pulp chamber was done and all canal orifices were identified Lubricant (RC Prep) was placed at the entrance of the canal and canals negotiated with 10 no. K file.
Working length was established 1mm short of apical foramen by electronic apex loactor (Root ZX) and confirmed radiographically.
Root canal preparation was done by using rotary files according to manufacturer's instructions.
In both groups, 5ml of sodium hypochlorite was used as irrigant after each instrument change. All the irrigation procedures was performed using a 30 gauge needle. 5% and 1% NaOCl was used in HC and LC, respectively.
After root canal instrumentation, canals was irrigated with 5ml of 17% EDTA solution for 1 minute followed by final wash with 5ml of 5% or 1% sodium hypochlorite, depending on the group.
Canals were dried with sterile absorbent paper points and filled with calcium hydroxide paste and the access cavity restored with Cavit.
The patients were recalled after 1 week. At the next appointment, the paste was removed with the use of Hedstroem files and copious irrigation with 5% or 1% sodium hypochlorite followed by 5ml 17% EDTA and a final rinse with 5ml 5% or 1% sodium hypochlorite.
Then, canals were obturated with the Gutta percha by lateral condensation technique and Zinc Oxide- Eugenol based sealer in both the groups.
After obturation, the cavity was restored permanently. Immediate post-operative radiograph was then be taken.
All the patients were prescribed Ibuprofen 400mg with the instructions to take only one tablet every 8 hours in the event of pain, if needed.Patients were asked to record the severity of pain using 10 cm VAS scale with 0 depicting no pain and 10 depicting maximum pain imaginable. Patients were asked to make a mark on the line that represented their level of perceived pain at 6 hr ,12 hr ,1 day,2 days,3 days,4 days,5 days,6 days and 7 days.One week later, patients returned with the completed questionnaires.
Follow up clinical and radiographic examination carried out every 3 months, till 12 month period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apical Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Root canal treatment with 5% NaOCl
Arm Type
Active Comparator
Arm Description
Root canal treatment with 5% NaOCl: 5 ml of 5% sodium hypochlorite was used during root canal treatment after each instrument change.After root canal instrumentation, canals irrigated with 5ml of 17% EDTA solution for 1 minute followed by final wash with 5ml of 5% sodium hypochlorite.
Arm Title
Root canal treatment with 1% NaOCl
Arm Type
Active Comparator
Arm Description
5 ml of 1% soium hypochlorite was used during root canal treatment after each instrument change.After root canal instrumentation, canals irrigated with 5ml of 17% EDTA solution for 1 minute followed by final wash with 5ml of 1% sodium hypochlorite.
Intervention Type
Procedure
Intervention Name(s)
Root canal treatment with 5% NaOCl
Other Intervention Name(s)
Endodontic treatment
Intervention Type
Procedure
Intervention Name(s)
Root canal treatment with 1% NaOCl
Other Intervention Name(s)
Endodontic treatment
Primary Outcome Measure Information:
Title
Radiographic success
Description
Treatment outcome was judged on the basis of radiographic findings recorded at the follow up visit and comparison of the radiographs obtained at post obturation and the follow-up visit.Change in Periapical Index (PAI) scores observed at 12-months was noted and scoring of each tooth was done according to the PAI scores and score less than 3 were considered as success.
Time Frame
Every 3 months till 12 months
Title
Clinical success
Description
Absence of pain and tenderness to palpation/ percussion, absence of sinus or any associated soft tissue swelling, tooth mobility, and no deterioration in periodontal probing depth as compared with baseline measurements comprised the criteria for clinical success.
Time Frame
Till 12 months
Secondary Outcome Measure Information:
Title
Pain intensity
Description
Pain intensity before and after treatmemt was recorded by use of 10cm VAS with zero depicting no pain and 10 depicting maximum pain.Patient rate their pain intensity by making a mark somewhere on the line that represents their pain intensity and VAS was scored by measuring the distance from the "no pain" end of line.
Time Frame
Pain intensity recorded at different intervals (preoperatively, after 6 hours, 12 hours, 1day, 2 days, 3 days, 4days, 5 days, 6 days and 7 days).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
47 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient willingness to participate in the study
Mature permanent mandibular first and second molars requiring primary root canal treatment
Diagnosis of pulpal necrosis, as confirmed by negative response to cold and electrical tests; and absence of bleeding on entering the pulp chamber
Radiographic evidence of periapical radiolucency (minimum size ≥ 2.0 × 2.0 mm)
Patient's age more than 18 years
Exclusion Criteria
Positive history of antibiotic use within past one month of the treatment.
Positive history of analgesic use within the past 3 days.
Patients who are pregnant, diabetic, immunocompromised, had serious medical illness or required antibiotic premedication
Patients with pockets ≥4mm or having marginal or furcal bone loss due to periodontitis
Teeth that are not suitable for rubber dam isolation
Previously accessed teeth and/or with procedural errors
Unrestorable tooth, fractured/ perforated roots, inflammatory root resorption
12. IPD Sharing Statement
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Effect of Sodium Hypochlorite Concentration on Success of Non-surgical Root Canal Treatment
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