Apical PeriodontitisNCT03278054
Effect of Different Instrumentation Technique on Endodontic Outcome
A study testing Root Canal Treatment with hand instruments, Root canal treatment with Protaper instruments and Root canal treatment with hybrid instrumentation in people with Apical Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Apical Periodontitis
- What is being tested?
- Root Canal Treatment with hand instruments, Root canal treatment with Protaper instruments and Root canal treatment with hybrid instrumentation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2015to 30 Oct 2016
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Effect of Different Instrumentation Technique on Outcome of Primary Non Surgical Endodontic Treatment
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.
Read the 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.
- Conditions
- Apical Periodontitis
- Being tested
- Root Canal Treatment with hand instruments, Root canal treatment with Protaper instruments, Root canal treatment with hybrid instrumentation
- Keywords
- apical periodontitis, hybrid, ProTaper, rotary
- 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 hand instrumentsOther
Root canal treatment was performed with K files.
Root canal treatment with Protaper instrumentsOther
Root canals were enlarged with S1 S2 F1F2 F2 Protaper instruments
Root canal treatment with hybrid instrumentationOther
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
| Study group | Role | What they receive |
|---|---|---|
| Manual group | Active comparator | Root Canal Treatment with hand instruments:Root canal treatment was done with instrumentation using manual K files. Receives: Other: Root Canal Treatment with hand instruments |
| ProTaper group | Active comparator | Root canal treatment with Protaper instruments:Root canal treatment was done using ProTaper rotary files S1, S2, F1, and F2. Receives: Other: Root canal treatment with Protaper instruments |
| Hybrid group | Active comparator | Root canal treatment with hybrid instrumentation:Root canal treatment was carried out using ProTaper and Hyflex CM files. Receives: Other: Root canal treatment with hybrid instrumentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic success
Periapical radiolucency was graded as Periapical Index (PAI) and scores less than 3 were grded as success
Measured: till 12 month period
Clinical success
Absence of pain tenderness sinus or swelling was graded as clinical success
Measured: 12 months
Secondary outcomes (1)
Pain intensity
Pain intensity before and after treatment was recorded using 0-100 mm VAS scale
Measured: every 24 hours for 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start1 May 2015
- Primary completion30 Nov 2015
- Study completion30 Oct 2016
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- 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
- NCT03278054
- Sponsor's protocol ID
- seema
- Status last verified
- Sep 2017
- First submitted
- 26 Jun 2017
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Instrumentation Technique on Outcome of Primary Non Surgical Endodontic Treatment
- ClinicalTrials.gov ID
- NCT03278054
- Acronym / sponsor ID
- seema
- Conditions
- Apical Periodontitis
- Keywords
- apical periodontitis, hybrid, ProTaper, rotary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 30 Nov 2015 (actual)
- Study completion
- 30 Oct 2016 (actual)
- First posted
- 11 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Manual group | Active comparator | Other: Root Canal Treatment with hand instrumentsRoot Canal Treatment with hand instruments:Root canal treatment was done with instrumentation using manual K files. |
| ProTaper group | Active comparator | Other: Root canal treatment with Protaper instrumentsRoot canal treatment with Protaper instruments:Root canal treatment was done using ProTaper rotary files S1, S2, F1, and F2. |
| Hybrid group | Active comparator | Other: Root canal treatment with hybrid instrumentationRoot canal treatment with hybrid instrumentation:Root canal treatment was carried out using ProTaper and Hyflex CM files. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 hand instrumentsRoot canal treatment was performed with K files. | Other | Manual group |
| Root canal treatment with Protaper instrumentsRoot canals were enlarged with S1 S2 F1F2 F2 Protaper instruments | Other | ProTaper group |
| Root canal treatment with hybrid instrumentationRoot 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 | Other | Hybrid group |
Primary outcome
Radiographic success
Time frame: till 12 month period
Periapical radiolucency was graded as Periapical Index (PAI) and scores less than 3 were grded as success
Clinical success
Time frame: 12 months
Absence of pain tenderness sinus or swelling was graded as clinical success
1 secondary outcome
Pain intensity
Time frame: every 24 hours for 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 11 Sep 2017.
- Individual participant dataSharing planned: No
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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 hand instruments, Root canal treatment with Protaper instruments and Root canal treatment with hybrid instrumentation 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 6 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 11 Sep 2017. 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: till 12 month period). 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 11 Sep 2017.