Asymptomatic Molar Teeth With Periapical LesionsNCT04454814
Postoperative Pain After Root Canal Preparation Using Different Engine-driven Systems
A study testing Protaper Universal instruments and Reciproc Blue instruments in people with Asymptomatic Molar Teeth With Periapical Lesions, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
A hundred twenty patients who had an asymptomatic mandibular molar teeth with periapical lesion were included. For each patient, teeth were prepared with Reciproc Blue or Protaper Universal instruments. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Asymptomatic Molar Teeth With Periapical Lesions
- What is being tested?
- Protaper Universal instruments and Reciproc Blue instruments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2017to 15 Feb 2020
- 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
- Patients without systemic diseases
- Patients who had a mandibular first molar with asymptomatic periapical lesion without previous endodontic treatment with no sensitivity to percussion
- Patients who had no spontaneous pre-treatment pain
- Patients not having taken any analgesics, antibiotics or corticosteroids before the treatment visit,
- Patients who had no allergic reaction to NaOCl and no intolerance to nonsteroidal anti-inflammatory drugs.
Who cannot join
- Patients who had severe periodontal disease
- The teeth with previous endodontic treatment
- The teeth with root canal calcification, root resorption
- The teeth that could not be isolated with rubber dam or were not suitable for further restoration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Pain Incidence of Asymptomatic Mandibular Molar Teeth After Using Different Engine-driven Systems
A hundred twenty patients who had an asymptomatic mandibular molar teeth with periapical lesion were included. For each patient, teeth were prepared with Reciproc Blue or Protaper Universal instruments. Each tooth was obturated with gutta-percha and resin-based sealer using single cone technique for mesial roots and for distal roots single cone and cold lateral compaction technique. Root canal treatment was performed in a single visit. Postoperative pain was assessed as no, mild, moderate, or severe at 6, 12, 24, 48, 72 hours and 7 days after obturation.
Read the detailed description
The aim of this study was to compare the effect of root canal preparation techniques on the occurrence and intensity of postoperative pain in patients with asymptomatic mandibular molar teeth with periapical lesions.A hundred twenty patients who had an asymptomatic mandibular molar teeth with periapical lesion were included. For each patient, teeth were prepared with Reciproc Blue or Protaper Universal instruments. Each tooth was obturated with gutta-percha and resin-based sealer using single cone technique for mesial roots and for distal roots single cone and cold lateral compaction technique. Root canal treatment was performed in a single visit. Postoperative pain was assessed as no, mild, moderate, or severe at 6, 12, 24, 48, 72 hours and 7 days after obturation.For the comparison of pain scores between the tested instrumentation systems, the Mann Whitney test was used. Differences between postoperative pain intencity for each instrumentation technique, at different time intervals, were assessed by the Friedman test. For the association of pain and an analgesic intake with gender, the chi-square test was performed. For the association of pain with age and an analgesic intake were calculated using Mann Whitney test. A P value < .05 or less was considered significant.
- Being tested
- Protaper Universal instruments, Reciproc Blue instruments
- Keywords
- one-visit root canal treatment,, engine-driven instruments,, asymptomatic molar teeth wtih periapical lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protaper Universal instrumentsOther
Root canal treatment using Protaper Universal instruments
Reciproc Blue instrumentsOther
Root canal treatment using Reciproc Blue instruments
| Study group | Role | What they receive |
|---|---|---|
| Rotary Engine-driven Instruments | Active comparator | The instrumentation protocol with Protaper Universal rotary files was began with an S1 file with a brushing movement to the two thirds of the working length and then an SX file was introduced to the two thirds of the working length with a brushing movement Afterwards, S1, S2, F1, F2 files in mesial roots and F4 files in distal roots were used to the working length, respectively. Protaper F2 instrument was then used to complete the canal preparation in mesial roots and Protaper F4 instrument was used to complete the canal preparation in distal roots. Receives: Other: Protaper Universal instruments |
| Reciprocal Engine-driven Instruments | Active comparator | The instrumentation of the root canal in the Reciproc Blue group began with a R25 instrument with a slow in-and-out pecking movement.According to the manufacturer instructions, a #10 K-file was inserted to the canal to check the canal is free to 1 mm beyond the prepared canal section. After each 3 pecks or when a resistance was encountered the instrument was pulled out of the canal. Afterward, the R25 instrument was inserted in to root canal until approximately two thirds of the working length.RB R25 instrument was then used to complete the canal preparation in mesial roots and RB R40 instrument was used to complete the canal preparation in distal roots. Receives: Other: Reciproc Blue instruments |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative pain
Postoperative pain after 6, 12, 24, 48, 72 hours and 7 days after obturation was measured using a modified 4-grade visual analogue scale (VAS) ranging from 1(no pain), 2(mild pain), 3 (moderate pain/pain relieved by analgesics), to (4) severe pain.
Measured: 6-hour to 7-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start15 Oct 2017
- Primary completion15 Jan 2020
- Study completion15 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Asymptomatic Molar Teeth With Periapical LesionsStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gözde Kandemir Demirci, Ege University
- Investigators
- Gözde Kandemir Demirci, Principal investigator, Ege University Faculty of DentistrySeniha Miçooğulları Kurt, Study chair, Ege University Faculty of DentistryBurcu Serefoglu, Study chair, Ege University Faculty of DentistryMehmet E Kaval, Study chair, Ege University Faculty of DentistryMehmet K Çalışkan, Study chair, Ege University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454814
- Sponsor's protocol ID
- 15-6/15
- Status last verified
- Jun 2020
- First submitted
- 26 Jun 2020
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mollashahi NF, Saberi EA, Havaei SR, Sabeti M. Comparison of Postoperative Pain after Root Canal Preparation with Two Reciprocating and Rotary Single-File Systems: A Randomized Clinical Trial. Iran Endod J. 2017 Winter;12(1):15-19. doi: 10.22037/iej.2017.03.
PubMed 28179917Shokraneh A, Ajami M, Farhadi N, Hosseini M, Rohani B. Postoperative endodontic pain of three different instrumentation techniques in asymptomatic necrotic mandibular molars with periapical lesion: a prospective, randomized, double-blind clinical trial. Clin Oral Investig. 2017 Jan;21(1):413-418. doi: 10.1007/s00784-016-1807-2. Epub 2016 Apr 4.
PubMed 27041109Kherlakian D, Cunha RS, Ehrhardt IC, Zuolo ML, Kishen A, da Silveira Bueno CE. Comparison of the Incidence of Postoperative Pain after Using 2 Reciprocating Systems and a Continuous Rotary System: A Prospective Randomized Clinical Trial. J Endod. 2016 Feb;42(2):171-6. doi: 10.1016/j.joen.2015.10.011. Epub 2015 Nov 29.
PubMed 26614017Gambarini G, Sudani DA, Carlo SD, Pompa G, Pacifici A, Pacifici L, Testarelli L (2013) Incidence and intensivity of postoperative pain and periapical inflammation after endodontic treatment with two different instrumentation techniques. European Journal of Inflammation. 10, 99-103.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Incidence of Asymptomatic Mandibular Molar Teeth After Using Different Engine-driven Systems
- ClinicalTrials.gov ID
- NCT04454814
- Acronym / sponsor ID
- 15-6/15
- Keywords
- one-visit root canal treatment,, engine-driven instruments,, asymptomatic molar teeth wtih periapical lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 15 Oct 2017 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 2 Jul 2020 (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.
A hundred twenty patients who had an asymptomatic mandibular molar teeth with periapical lesion were included. For each patient, teeth were prepared with Reciproc Blue or Protaper Universal instruments. Each tooth was obturated with gutta-percha and resin-based sealer using single cone technique for mesial roots and for distal roots single cone and cold lateral compaction technique. Root canal treatment was performed in a single visit. Postoperative pain was assessed as no, mild, moderate, or severe at 6, 12, 24, 48, 72 hours and 7 days after obturation.
Detailed description
The aim of this study was to compare the effect of root canal preparation techniques on the occurrence and intensity of postoperative pain in patients with asymptomatic mandibular molar teeth with periapical lesions.A hundred twenty patients who had an asymptomatic mandibular molar teeth with periapical lesion were included. For each patient, teeth were prepared with Reciproc Blue or Protaper Universal instruments. Each tooth was obturated with gutta-percha and resin-based sealer using single cone technique for mesial roots and for distal roots single cone and cold lateral compaction technique. Root canal treatment was performed in a single visit. Postoperative pain was assessed as no, mild, moderate, or severe at 6, 12, 24, 48, 72 hours and 7 days after obturation.For the comparison of pain scores between the tested instrumentation systems, the Mann Whitney test was used. Differences between postoperative pain intencity for each instrumentation technique, at different time intervals, were assessed by the Friedman test. For the association of pain and an analgesic intake with gender, the chi-square test was performed. For the association of pain with age and an analgesic intake were calculated using Mann Whitney test. A P value < .05 or less was considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotary Engine-driven Instruments | Active comparator | Other: Protaper Universal instrumentsThe instrumentation protocol with Protaper Universal rotary files was began with an S1 file with a brushing movement to the two thirds of the working length and then an SX file was introduced to the two thirds of the working length with a brushing movement Afterwards, S1, S2, F1, F2 files in mesial roots and F4 files in distal roots were used to the working length, respectively. Protaper F2 instrument was then used to complete the canal preparation in mesial roots and Protaper F4 instrument was used to complete the canal preparation in distal roots. |
| Reciprocal Engine-driven Instruments | Active comparator | Other: Reciproc Blue instrumentsThe instrumentation of the root canal in the Reciproc Blue group began with a R25 instrument with a slow in-and-out pecking movement.According to the manufacturer instructions, a #10 K-file was inserted to the canal to check the canal is free to 1 mm beyond the prepared canal section. After each 3 pecks or when a resistance was encountered the instrument was pulled out of the canal. Afterward, the R25 instrument was inserted in to root canal until approximately two thirds of the working length.RB R25 instrument was then used to complete the canal preparation in mesial roots and RB R40 instrument was used to complete the canal preparation in distal roots. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients without systemic diseases
- Patients who had a mandibular first molar with asymptomatic periapical lesion without previous endodontic treatment with no sensitivity to percussion
- Patients who had no spontaneous pre-treatment pain
- Patients not having taken any analgesics, antibiotics or corticosteroids before the treatment visit,
- Patients who had no allergic reaction to NaOCl and no intolerance to nonsteroidal anti-inflammatory drugs.
Key exclusion criteria (4 listed)
- Patients who had severe periodontal disease
- The teeth with previous endodontic treatment
- The teeth with root canal calcification, root resorption
- The teeth that could not be isolated with rubber dam or were not suitable for further restoration
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 |
|---|---|---|
| Protaper Universal instrumentsRoot canal treatment using Protaper Universal instruments | Other | Rotary Engine-driven Instruments |
| Reciproc Blue instrumentsRoot canal treatment using Reciproc Blue instruments | Other | Reciprocal Engine-driven Instruments |
Primary outcome
The incidence of postoperative pain
Time frame: 6-hour to 7-day
Postoperative pain after 6, 12, 24, 48, 72 hours and 7 days after obturation was measured using a modified 4-grade visual analogue scale (VAS) ranging from 1(no pain), 2(mild pain), 3 (moderate pain/pain relieved by analgesics), to (4) severe pain.
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 2 Jul 2020.
- Background: PubMed 28179917Mollashahi NF, Saberi EA, Havaei SR, Sabeti M. Comparison of Postoperative Pain after Root Canal Preparation with Two Reciprocating and Rotary Single-File Systems: A Randomized Clinical Trial. Iran Endod J. 2017 Winter;12(1):15-19. doi: 10.22037/iej.2017.03.
- Background: PubMed 27041109Shokraneh A, Ajami M, Farhadi N, Hosseini M, Rohani B. Postoperative endodontic pain of three different instrumentation techniques in asymptomatic necrotic mandibular molars with periapical lesion: a prospective, randomized, double-blind clinical trial. Clin Oral Investig. 2017 Jan;21(1):413-418. doi: 10.1007/s00784-016-1807-2. Epub 2016 Apr 4.
- Results publication: PubMed 26614017Kherlakian D, Cunha RS, Ehrhardt IC, Zuolo ML, Kishen A, da Silveira Bueno CE. Comparison of the Incidence of Postoperative Pain after Using 2 Reciprocating Systems and a Continuous Rotary System: A Prospective Randomized Clinical Trial. J Endod. 2016 Feb;42(2):171-6. doi: 10.1016/j.joen.2015.10.011. Epub 2015 Nov 29.
- Results publicationGambarini G, Sudani DA, Carlo SD, Pompa G, Pacifici A, Pacifici L, Testarelli L (2013) Incidence and intensivity of postoperative pain and periapical inflammation after endodontic treatment with two different instrumentation techniques. European Journal of Inflammation. 10, 99-103.
- Individual participant dataSharing planned: No
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.
Gözde Kandemir Demirci principal investigator
Ege University Faculty of Dentistry
Seniha Miçooğulları Kurt study chair
Ege University Faculty of Dentistry
Burcu Serefoglu study chair
Ege University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protaper Universal instruments and Reciproc Blue instruments in people with Asymptomatic Molar Teeth With Periapical Lesions, run by Ege University at 1 site in Turkey (Türkiye).
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 4 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 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The incidence of postoperative pain (time frame: 6-hour to 7-day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04454814, which also lists 4 linked publications.
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 2 Jul 2020.