Postoperative PainNCT04326998
Gutta-percha Solvent on Postoperative Pain After Root Canal Retreatment
A study testing solvent and non-solvent in people with Postoperative Pain and Root Canal, run by Mahidol University at 1 site in Thailand.
Trial summary
The process of non-surgical retreatment includes removing the previous root canal filling materials, disinfecting and sealing the root canal system to prevent re-infection. Gutta-percha is the most common root canal filling material used with various types of sealers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Root Canal, Retreatment
- What is being tested?
- solvent and non-solvent
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 18 Sep 2019to 18 Jun 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- not be contra-indicated with medication used in this study (ibuprofen)
- have a previously treated endodontic single-root tooth with the need of retreatment
- all those teeth must be restorable
- old root canal filling materials must be located at 1 to 3 mm from the radiographic apex in the periapical radiograph
Who cannot join
- open apex, root resorption or root perforation
- participants presenting pre-operative pain and/or swelling at the appointment visit
- taking analgesics or antibiotics less than one week before appointment visit
- experiencing problems in completing the pain questionnaires
- tooth which does not contain gutta-percha
- cannot be patent through the apex at the appointment visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Natural Gutta-percha Solvent Did Not Affect Postoperative Pain in Retreatment: a Randomized Clinical Trial
The process of non-surgical retreatment includes removing the previous root canal filling materials, disinfecting and sealing the root canal system to prevent re-infection. Gutta-percha is the most common root canal filling material used with various types of sealers. To remove gutta-percha, solvent has been suggested because of its ability to dissolve gutta-percha. The new formula, under the brand name, GuttaClear, has been investigated for its comparable dissolving ability and lower cytotoxicity when compared with others that are currently used. However, no information is currently available of GuttaClear solvent concerning postoperative pain. Therefore, the present study will evaluate postoperative pain after non-surgical retreatment cases using GuttaClear as a solvent compared with no solvent used. Sixty participants are chosen and distributed into 2 groups, randomly. After the procedures, participants will receive the questionnaires about postoperative pain and the amount of medication intake. Both will be recorded at six time periods: (1) immediately after procedure; (2) 6 hours after procedure; (3) 12 hours after procedure; (4) 24 hours after procedure; (5) 48 hours after procedure and (6) 72 hours after procedure.
- Conditions
- Postoperative Pain, Root Canal, Retreatment
- Being tested
- solvent, non-solvent
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
solventProcedure or surgery
using solvent (GuttaClear) in procedure
non-solventProcedure or surgery
non-solvent
| Study group | Role | What they receive |
|---|---|---|
| non-solvent | Active comparator | mechanical or heat treatment Receives: Procedure: non-solvent |
| solvent | Experimental | GuttaClear Receives: Procedure: solvent |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
NRS score recorded from 0 to 10 while 0 means no pain and 10 means the worst possible pain
Measured: 3 days
Secondary outcomes (1)
number of Ibuprofen intake
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start18 Sep 2019
- Primary completion18 Mar 2021
- Study completion18 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Duangrat Sirijindamai, DDS, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326998
- Sponsor's protocol ID
- MU-DT/PY-IRB 2019/054.2608
- Status last verified
- Sep 2021
- First submitted
- 27 Mar 2020
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jantarat J, Malhotra W, Sutimuntanakul S. Efficacy of grapefruit, tangerine, lime, and lemon oils as solvents for softening gutta-percha in root canal retreatment procedures. J Investig Clin Dent. 2013 Feb;4(1):60-3. doi: 10.1111/j.2041-1626.2012.00143.x.
PubMed 23382062Genc 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 31093742Topcuoglu HS, Topcuoglu G. Postoperative pain after the removal of root canal filling material using different techniques in teeth with failed root canal therapy: a randomized clinical trial. Acta Odontol Scand. 2017 May;75(4):249-254. doi: 10.1080/00016357.2017.1283707. Epub 2017 Feb 5.
PubMed 28162017Garcia-Font M, Duran-Sindreu F, Morello S, Irazusta S, Abella F, Roig M, Olivieri JG. Postoperative pain after removal of gutta-percha from root canals in endodontic retreatment using rotary or reciprocating instruments: a prospective clinical study. Clin Oral Investig. 2018 Sep;22(7):2623-2631. doi: 10.1007/s00784-018-2361-x. Epub 2018 Feb 2.
PubMed 29396645Sirijindamai D, Wichai W, Mitrirattanakul S, Jantarat J. Effect of GuttaClear on Postoperative Pain After Root Canal Retreatment: A Randomized Clinical Trial. Eur Endod J. 2023 Jan;8(1):55-64. doi: 10.14744/eej.2022.85047.
PubMed 36748447
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural Gutta-percha Solvent Did Not Affect Postoperative Pain in Retreatment: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04326998
- Acronym / sponsor ID
- MU-DT/PY-IRB 2019/054.2608
- Conditions
- Postoperative Pain, Root Canal, Retreatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 18 Mar 2021 (actual)
- Study completion
- 18 Jun 2021 (actual)
- First posted
- 30 Mar 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.
The process of non-surgical retreatment includes removing the previous root canal filling materials, disinfecting and sealing the root canal system to prevent re-infection. Gutta-percha is the most common root canal filling material used with various types of sealers. To remove gutta-percha, solvent has been suggested because of its ability to dissolve gutta-percha. The new formula, under the brand name, GuttaClear, has been investigated for its comparable dissolving ability and lower cytotoxicity when compared with others that are currently used. However, no information is currently available of GuttaClear solvent concerning postoperative pain. Therefore, the present study will evaluate postoperative pain after non-surgical retreatment cases using GuttaClear as a solvent compared with no solvent used. Sixty participants are chosen and distributed into 2 groups, randomly. After the procedures, participants will receive the questionnaires about postoperative pain and the amount of medication intake. Both will be recorded at six time periods: (1) immediately after procedure; (2) 6 hours after procedure; (3) 12 hours after procedure; (4) 24 hours after procedure; (5) 48 hours after procedure and (6) 72 hours after procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-solvent | Active comparator | Procedure: non-solventmechanical or heat treatment |
| solvent | Experimental | Procedure: solventGuttaClear |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- not be contra-indicated with medication used in this study (ibuprofen)
- have a previously treated endodontic single-root tooth with the need of retreatment
- all those teeth must be restorable
- old root canal filling materials must be located at 1 to 3 mm from the radiographic apex in the periapical radiograph
Key exclusion criteria (6 listed)
- open apex, root resorption or root perforation
- participants presenting pre-operative pain and/or swelling at the appointment visit
- taking analgesics or antibiotics less than one week before appointment visit
- experiencing problems in completing the pain questionnaires
- tooth which does not contain gutta-percha
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 |
|---|---|---|
| solventusing solvent (GuttaClear) in procedure | Procedure or surgery | solvent |
| non-solventnon-solvent | Procedure or surgery | non-solvent |
Primary outcome
postoperative pain
Time frame: 3 days
NRS score recorded from 0 to 10 while 0 means no pain and 10 means the worst possible pain
1 secondary outcome
number of Ibuprofen intake
Time frame: 3 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 21 Sep 2021.
- Results publication: PubMed 23382062Jantarat J, Malhotra W, Sutimuntanakul S. Efficacy of grapefruit, tangerine, lime, and lemon oils as solvents for softening gutta-percha in root canal retreatment procedures. J Investig Clin Dent. 2013 Feb;4(1):60-3. doi: 10.1111/j.2041-1626.2012.00143.x.
- Results publication: 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.
- Results publication: PubMed 28162017Topcuoglu HS, Topcuoglu G. Postoperative pain after the removal of root canal filling material using different techniques in teeth with failed root canal therapy: a randomized clinical trial. Acta Odontol Scand. 2017 May;75(4):249-254. doi: 10.1080/00016357.2017.1283707. Epub 2017 Feb 5.
- Results publication: PubMed 29396645Garcia-Font M, Duran-Sindreu F, Morello S, Irazusta S, Abella F, Roig M, Olivieri JG. Postoperative pain after removal of gutta-percha from root canals in endodontic retreatment using rotary or reciprocating instruments: a prospective clinical study. Clin Oral Investig. 2018 Sep;22(7):2623-2631. doi: 10.1007/s00784-018-2361-x. Epub 2018 Feb 2.
- Derived from this study: PubMed 36748447Sirijindamai D, Wichai W, Mitrirattanakul S, Jantarat J. Effect of GuttaClear on Postoperative Pain After Root Canal Retreatment: A Randomized Clinical Trial. Eur Endod J. 2023 Jan;8(1):55-64. doi: 10.14744/eej.2022.85047.
- 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.
Duangrat Sirijindamai, DDS principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing solvent and non-solvent in people with Postoperative Pain and Root Canal, run by Mahidol University at 1 site in Thailand.
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 4 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 21 Sep 2021. 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 Thailand. 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 (time frame: 3 days). 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 NCT04326998, which also lists 5 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 21 Sep 2021.