Apical PeriodontitisNCT03288467
Effect of Sodium Hypochlorite Concentration on Success of Non-surgical Root Canal Treatment
A study testing Root canal treatment with 5% NaOCl and Root canal treatment with 1% NaOCl in people with Apical Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 47 years
- Conditions the study is for
- Apical Periodontitis
- What is being tested?
- Root canal treatment with 5% NaOCl and Root canal treatment with 1% NaOCl
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 6 Nov 2016to 30 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 47 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Effect of Sodium Hypochlorite Concentration on Success of Non-surgical Root Canal Treatment: A Randomized Controlled Trial.
.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.
Read the 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.
- Conditions
- Apical Periodontitis
- Being tested
- Root canal treatment with 5% NaOCl, Root canal treatment with 1% NaOCl
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root canal treatment with 5% NaOClProcedure or surgery
Also called Endodontic treatment
Root canal treatment with 1% NaOClProcedure or surgery
Also called Endodontic treatment
| Study group | Role | What they receive |
|---|---|---|
| Root canal treatment with 5% NaOCl | Active comparator | 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. Receives: Procedure: Root canal treatment with 5% NaOCl |
| Root canal treatment with 1% NaOCl | Active comparator | 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. Receives: Procedure: Root canal treatment with 1% NaOCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every 3 months till 12 months
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.
Measured: Till 12 months
Secondary outcomes (1)
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study start6 Nov 2016
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical PeriodontitisStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03288467
- Sponsor's protocol ID
- Neha Verma
- Status last verified
- Sep 2017
- First submitted
- 11 Sep 2017
- Last updated
- 23 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sodium Hypochlorite Concentration on Success of Non-surgical Root Canal Treatment: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03288467
- Acronym / sponsor ID
- Neha Verma
- Conditions
- Apical Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 6 Nov 2016 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 20 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
.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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Root canal treatment with 5% NaOCl | Active comparator | Procedure: Root canal treatment with 5% NaOClRoot 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. |
| Root canal treatment with 1% NaOCl | Active comparator | Procedure: Root canal treatment with 1% NaOCl5 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. |
Who may qualify
- Ages
- 18 to 47 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Root canal treatment with 5% NaOClAlso: Endodontic treatment | Procedure or surgery | Root canal treatment with 5% NaOCl |
| Root canal treatment with 1% NaOClAlso: Endodontic treatment | Procedure or surgery | Root canal treatment with 1% NaOCl |
Primary outcome
Radiographic success
Time frame: Every 3 months till 12 months
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
Time frame: Till 12 months
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.
1 secondary outcome
Pain intensity
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
Related trials for Apical Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
Influence of Continuous Rotation Versus Reciprocation Motion of MG3 Blue Rotary File on Postoperative Pain and Intracanal Bacterial Reduction of Teeth With Necrotic Pulps.
Necrotic Pulps With no Apical Periodontitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Root canal treatment with 5% NaOCl and Root canal treatment with 1% NaOCl in people with Apical Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic success (time frame: Every 3 months till 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2018.