Root Canal InfectionNCT03756363
The Effect of Solvent Usage on Post-treatment Pain
A study testing Non-solvent and Solvent in people with Root Canal Infection and Pain, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
No clinical evidence has been yet published regarding the comparison of postoperative pain after removal of the root canal fillings with or without solvent. The aim of this study was to evaluate the effect of combined usage of ProTaper retreatment instruments and a gutta-percha solvent, on the postoperative pain… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Root Canal Infection, Pain
- What is being tested?
- Non-solvent and Solvent
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Oct 2018to 10 Jan 2019
- 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
- Systemically healthy patient who has a failed root canal treatment.
- Asymptomatic single rooted teeth that had an initial root canal filling diagnosed with chronic apical periodontitis.
- Patients agreed to parcitipate in the study
Who cannot join
- Overfilled teeth,
- teeth with intraradicular posts,
- existence of a sinus tract,
- consumption of antibiotics or analgesics within one month,
- pregnancy,
- history of trauma,
- traumatic occlusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Pain After Removal of Gutta-percha From Root Canals in Endodontic Retreatment Using a Solvent
No clinical evidence has been yet published regarding the comparison of postoperative pain after removal of the root canal fillings with or without solvent. The aim of this study was to evaluate the effect of combined usage of ProTaper retreatment instruments and a gutta-percha solvent, on the postoperative pain intensity after retreatment.
Read the detailed description
Scientific literature contains a few studies regarding the amount of apically extruded debris caused by solvent or solvent free use of rotary instruments. It was reported that the use of ProTaper retreatment instruments in combination with gutta-percha solvent reduced the amount of apically extruded debris compared to their solvent free use. Nevertheless,no clinical evidence has been yet published regarding the comparison of postoperative pain after removal of the root canal fillings with or without solvent. The aim of this study was to evaluate the effect of combined usage of ProTaper retreatment instruments and gutta-percha solvent, on the postoperative pain intensity after retreatment. The adult patients (18-59 ages) who referred to Department of Endodontics with a diagnose of failed root canal treatment were examined radiographically and clinically. Endodontically treated, clinically asymptomatic, single-rooted teeth with one canal exhibiting chronic periapical infection were included. A hundred cases who matched the determined criteria were selected and randomly allocated to two groups:
Non-solvent Group (n=50):
ProTaper retreatment instruments were used in combination with with X-Smart electric motor for the removal of root canal fillings.
Solvent Group (n=50):
ProTaper retreatment instruments were used with the abovementioned technique but in combination with a gutta-percha solvent
- Conditions
- Root Canal Infection, Pain
- Being tested
- Non-solvent, Solvent
- Keywords
- Postoperative pain, Debris extrusion, Filling removal, solvent
- Medical subject headings
- Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-solventProcedure or surgery
Root canal filling removal using ProTaper retreatment instruments. Single session retreatment procedures.
SolventProcedure or surgery
Root canal filling removal using ProTaper retreatment instruments in combination with a gutta percha solvent. Single session retreatment procedures.
| Study group | Role | What they receive |
|---|---|---|
| Non-solvent | Experimental | Non-solvent use of a rotary retreatment system Receives: Procedure: Non-solvent |
| Solvent | Experimental | Solvent use in combination with a rotary retreatment system Receives: Procedure: Solvent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain after removal of gutta-percha with or without solvent
Pain intensity was evaluated at 24 hours after retreatment procedures. An 11-item numerical rating scale (NRS) was used to assess the pain. This NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0 -10 integers) that best reflects the intensity of their pain. Number 0 represents 'no pain' whereas number 10 represents 'pain as bad as someone can imagine'.All patients were requested to mark a number corresponding to their average pain.
Measured: 24 hours postoperatively
Secondary outcomes (2)
Postoperative pain after removal of gutta-percha with or without solvent
Pain intensity was evaluated at 48 hours after retreatment procedures. An 11-item numerical rating scale (NRS) was used to assess the pain. This NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0 -10 integers) that best reflects the intensity of their pain. Number 0 represents 'no pain' whereas number 10 represents 'pain as bad as someone can imagine' . All patients were requested to mark a number corresponding to their average pain.
Measured: 24 to 48 hours postoperatively
Postoperative pain after removal of gutta-percha with or without solvent
Pain intensity was evaluated at 72 hours after retreatment procedures. An 11-item numerical rating scale (NRS) was used to assess the pain. This NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0 -10 integers) that best reflects the intensity of their pain. Number 0 represents 'no pain' whereas number 10 represents 'pain as bad as someone can imagine'. All patients were requested to mark a number corresponding to their average pain.
Measured: 48 to 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start22 Oct 2018
- Primary completion5 Jan 2019
- Study completion10 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Root Canal InfectionStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozgur Genc Sen, Yuzuncu Yil University
- Investigators
- Ozgur G Genc Sen, Principal investigator, Yuzuncu Yil University, Faculty of DentistryAli G Erdemir, Study director, Yuzuncu Yil University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756363
- Sponsor's protocol ID
- B.30.2.YYU.0.01.00.00/125
- Status last verified
- Jul 2019
- First submitted
- 26 Nov 2018
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Genc Sen O, Erdemir A, Canakci BC. Effect of solvent use on postoperative pain in root canal retreatment: a randomized, controlled clinical trial. Clin Oral Investig. 2020 Jan;24(1):257-263. doi: 10.1007/s00784-019-02948-3. Epub 2019 May 15.
PubMed 31093742
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain After Removal of Gutta-percha From Root Canals in Endodontic Retreatment Using a Solvent
- ClinicalTrials.gov ID
- NCT03756363
- Acronym / sponsor ID
- B.30.2.YYU.0.01.00.00/125
- Conditions
- Root Canal Infection, Pain
- Keywords
- Postoperative pain, Debris extrusion, Filling removal, solvent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 5 Jan 2019 (actual)
- Study completion
- 10 Jan 2019 (actual)
- First posted
- 28 Nov 2018 (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.
No clinical evidence has been yet published regarding the comparison of postoperative pain after removal of the root canal fillings with or without solvent. The aim of this study was to evaluate the effect of combined usage of ProTaper retreatment instruments and a gutta-percha solvent, on the postoperative pain intensity after retreatment.
Detailed description
Scientific literature contains a few studies regarding the amount of apically extruded debris caused by solvent or solvent free use of rotary instruments. It was reported that the use of ProTaper retreatment instruments in combination with gutta-percha solvent reduced the amount of apically extruded debris compared to their solvent free use. Nevertheless,no clinical evidence has been yet published regarding the comparison of postoperative pain after removal of the root canal fillings with or without solvent. The aim of this study was to evaluate the effect of combined usage of ProTaper retreatment instruments and gutta-percha solvent, on the postoperative pain intensity after retreatment. The adult patients (18-59 ages) who referred to Department of Endodontics with a diagnose of failed root canal treatment were examined radiographically and clinically. Endodontically treated, clinically asymptomatic, single-rooted teeth with one canal exhibiting chronic periapical infection were included. A hundred cases who matched the determined criteria were selected and randomly allocated to two groups:
Non-solvent Group (n=50):
ProTaper retreatment instruments were used in combination with with X-Smart electric motor for the removal of root canal fillings.
Solvent Group (n=50):
ProTaper retreatment instruments were used with the abovementioned technique but in combination with a gutta-percha solvent
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-solvent | Experimental | Procedure: Non-solventNon-solvent use of a rotary retreatment system |
| Solvent | Experimental | Procedure: SolventSolvent use in combination with a rotary retreatment system |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Systemically healthy patient who has a failed root canal treatment.
- Asymptomatic single rooted teeth that had an initial root canal filling diagnosed with chronic apical periodontitis.
- Patients agreed to parcitipate in the study
Key exclusion criteria (7 listed)
- Overfilled teeth,
- teeth with intraradicular posts,
- existence of a sinus tract,
- consumption of antibiotics or analgesics within one month,
- pregnancy,
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 |
|---|---|---|
| Non-solventRoot canal filling removal using ProTaper retreatment instruments. Single session retreatment procedures. | Procedure or surgery | Non-solvent |
| SolventRoot canal filling removal using ProTaper retreatment instruments in combination with a gutta percha solvent. Single session retreatment procedures. | Procedure or surgery | Solvent |
Primary outcome
Postoperative pain after removal of gutta-percha with or without solvent
Time frame: 24 hours postoperatively
Pain intensity was evaluated at 24 hours after retreatment procedures. An 11-item numerical rating scale (NRS) was used to assess the pain. This NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0 -10 integers) that best reflects the intensity of their pain. Number 0 represents 'no pain' whereas number 10 represents 'pain as bad as someone can imagine'.All patients were requested to mark a number corresponding to their average pain.
2 secondary outcomes
Postoperative pain after removal of gutta-percha with or without solvent
Time frame: 24 to 48 hours postoperatively
Postoperative pain after removal of gutta-percha with or without solvent
Time frame: 48 to 72 hours postoperatively
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 8 Jul 2019.
- Derived from this study: PubMed 31093742Genc Sen O, Erdemir A, Canakci BC. Effect of solvent use on postoperative pain in root canal retreatment: a randomized, controlled clinical trial. Clin Oral Investig. 2020 Jan;24(1):257-263. doi: 10.1007/s00784-019-02948-3. Epub 2019 May 15.
- 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.
Ozgur G Genc Sen principal investigator
Yuzuncu Yil University, Faculty of Dentistry
Ali G Erdemir study director
Yuzuncu Yil 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 Non-solvent and Solvent in people with Root Canal Infection and Pain, run by Yuzuncu Yil 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 3 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 8 Jul 2019. 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?
Postoperative pain after removal of gutta-percha with or without solvent (time frame: 24 hours postoperatively). 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 NCT03756363, which also lists 1 linked publication.
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 8 Jul 2019.