Irriversible PulpitisNCT06953856
Analyzing the Impact of Occlusal Reduction on the Pain Following Root Canal Therapy in Molar Teeth With and Without Pain in Turkish Patients.
A study testing occlusal reduction in people with Irriversible Pulpitis, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
Introduction: This study aimed to compare the intensity of postoperative pain after single-visit root canal treatment of symptomatic or asymptomatic teeth following occlusal reduction. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Irriversible Pulpitis
- What is being tested?
- occlusal reduction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Aug 2020to 5 Feb 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healty patients
- Maxillary and mandibulary first and second molars
- Irriversible pulpitis cases with or without prior discomfort
Who cannot join
- Patients under 18 years old,
- Patients older 65 years old,
- Teeth with previously undergone root canal treatment,
- Complicating systemic diseases,
- Allergies o local anesthetic agents,
- Presence of acute apical apsesses,
Show all 15Show fewer
- History of trauma,
- Analgesic, antibiotic or antiinflamatory intake 7 days before treatment,
- Periodontal pockets deeper than 4 mm,
- Multiple teeth that require endodontic treatment,
- Pregnancy,
- Teeth that can not be restored,
- Patients who needed emergency treatment,
- Grade 2 or 3 mobility,
- Patients with bruxism
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sakarya University Facultry of Dentistry
Adapazarı, Sakarya, 54050
About this study
Official title: Effect of Occlusal Reduction on Post-operative Pain of Symptomatic and Asymptomatic Molar Teeth
Introduction: This study aimed to compare the intensity of postoperative pain after single-visit root canal treatment of symptomatic or asymptomatic teeth following occlusal reduction.
Methods: A total of 140 symptomatic or asymptomatic patients in need of root canal therapy were registered in this prospective, single-center, single-blind, randomized clinical trial.
For all patients, root canal treatment was carried out in a single visit, and the teeth were restored using composite resin. The teeth were randomly allocated into two equal groups according to whether occlusal reduction was done or not. The patients' pain were assessed using a 0-3 verbal rate scale 1, 3, and 7 days following root canal treatment. The pain incidence and intensity were compared using the chi-square and Fisher's exact tests.
Read the detailed description
Root canal treatments is usually associated with post-operative pain and this is a bothersome situation for both patient and practitioner. Due to this reason number of researches focus on the factors that may relief patients pain. Occlusal reduction is one of the factors that means the chewing surface of the teeth are cut off and no longer in contact.Despite the large number of studies on this subject, no consensus has been reached. Decoupling group standardization and arriving at a more consistent conclusion were the goals of this research. The aim of this research is to evaluate the impact of occlusal reduction on postoperative pain in both symptomatic and asymptomatic molar teeth.
- Conditions
- Irriversible Pulpitis
- Being tested
- occlusal reduction
- Keywords
- Analgesics, Occlusal reduction, Postoperative pain, Single-visit endodontic treatment
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
occlusal reductionOther
Also called occlusal reduction procedure
Occlusal reduction is a procedure that applied patients for different aims. One of these aims is pain relief after endodontic treatment and there are some studies about this topic however, there is no consensus about it. This discrepency could be related to differences of the inclusion criteria for this reason this study aimed to get a reliable result.
| Study group | Role | What they receive |
|---|---|---|
| Occlusal reduction, | Other | one of the group received occlusal reduction after root canal treatment while other did not. Receives: Other: occlusal reduction |
| no occlusal reduction | No intervention | this group did not receive any occlusal reduction after root canal treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of occlusal reduction on pain relief
This study was primarily aim to understand the effect of occlusal reduction on pain relief after root canal treatment of irriversible pulpitis. After root canal treatment patients were called to estimate their pain levels. A 0-3 rate verbal rating scale was used for this aim.
0: no discomfort or pain
- mild pain (not requiring analgesic medication)
- moderate pain (requiring analgesic medication)
- severe pain (interfering with physical activity and minimally responsive to analgesics)
Measured: from enrollment to the end each patient called for a week to understand their pain levels and each of them called after 1st, 3th, 7th days treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start3 Aug 2020
- Primary completion29 Jan 2021
- Study completion5 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Irriversible PulpitisStudies of the same condition, open and under way.
- More trials run by Sakarya 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AYSENUR KAMACI ESEN, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953856
- Sponsor's protocol ID
- E-71522473-050.01.04-39802-329
- Status last verified
- Apr 2025
- First submitted
- 5 Apr 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Ahmed YE, Emara RS, Sarhan SM, El Boghdadi RM, El-Bayoumi MAA, El-Far HMM, Sabet NE, Abou El-Nasr HM, Gawdat SI, Amin SAW. Post-treatment endodontic pain following occlusal reduction in mandibular posterior teeth with symptomatic irreversible pulpitis and sensitivity to percussion: a single-centre randomized controlled trial. Int Endod J. 2020 Sep;53(9):1170-1180. doi: 10.1111/iej.13328. Epub 2020 Jun 15.
PubMed 32418236Parirokh M, Rekabi AR, Ashouri R, Nakhaee N, Abbott PV, Gorjestani H. Effect of occlusal reduction on postoperative pain in teeth with irreversible pulpitis and mild tenderness to percussion. J Endod. 2013 Jan;39(1):1-5. doi: 10.1016/j.joen.2012.08.008. Epub 2012 Sep 29.
PubMed 23228248Emara RS, Abou El Nasr HM, El Boghdadi RM. Evaluation of postoperative pain intensity following occlusal reduction in teeth associated with symptomatic irreversible pulpitis and symptomatic apical periodontitis: a randomized clinical study. Int Endod J. 2019 Mar;52(3):288-296. doi: 10.1111/iej.13012. Epub 2018 Sep 28.
PubMed 30171777Rosenberg PA, Babick PJ, Schertzer L, Leung A. The effect of occlusal reduction on pain after endodontic instrumentation. J Endod. 1998 Jul;24(7):492-6. doi: 10.1016/S0099-2399(98)80054-X.
PubMed 9693578Nguyen-Nhon D, Nagendrababu V, Pulikkotil SJ, Rossi-Fedele G. Effect of occlusal reduction on postendodontic pain: A systematic review and meta-analysis of randomised clinical trials. Aust Endod J. 2020 Aug;46(2):282-294. doi: 10.1111/aej.12380. Epub 2019 Oct 22.
PubMed 31638301Sathorn C, Parashos P, Messer H. The prevalence of postoperative pain and flare-up in single- and multiple-visit endodontic treatment: a systematic review. Int Endod J. 2008 Feb;41(2):91-9. doi: 10.1111/j.1365-2591.2007.01316.x. Epub 2007 Oct 23.
PubMed 17956561
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Occlusal Reduction on Post-operative Pain of Symptomatic and Asymptomatic Molar Teeth
- ClinicalTrials.gov ID
- NCT06953856
- Acronym / sponsor ID
- E-71522473-050.01.04-39802-329
- Conditions
- Irriversible Pulpitis
- Keywords
- Analgesics, Occlusal reduction, Postoperative pain, Single-visit endodontic treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 29 Jan 2021 (actual)
- Study completion
- 5 Feb 2021 (actual)
- First posted
- 1 May 2025 (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.
Introduction: This study aimed to compare the intensity of postoperative pain after single-visit root canal treatment of symptomatic or asymptomatic teeth following occlusal reduction.
Methods: A total of 140 symptomatic or asymptomatic patients in need of root canal therapy were registered in this prospective, single-center, single-blind, randomized clinical trial.
For all patients, root canal treatment was carried out in a single visit, and the teeth were restored using composite resin. The teeth were randomly allocated into two equal groups according to whether occlusal reduction was done or not. The patients' pain were assessed using a 0-3 verbal rate scale 1, 3, and 7 days following root canal treatment. The pain incidence and intensity were compared using the chi-square and Fisher's exact tests.
Detailed description
Root canal treatments is usually associated with post-operative pain and this is a bothersome situation for both patient and practitioner. Due to this reason number of researches focus on the factors that may relief patients pain. Occlusal reduction is one of the factors that means the chewing surface of the teeth are cut off and no longer in contact.Despite the large number of studies on this subject, no consensus has been reached. Decoupling group standardization and arriving at a more consistent conclusion were the goals of this research. The aim of this research is to evaluate the impact of occlusal reduction on postoperative pain in both symptomatic and asymptomatic molar teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Occlusal reduction, | Other | Other: occlusal reductionone of the group received occlusal reduction after root canal treatment while other did not. |
| no occlusal reduction | No intervention | –this group did not receive any occlusal reduction after root canal treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healty patients
- Maxillary and mandibulary first and second molars
- Irriversible pulpitis cases with or without prior discomfort
Key exclusion criteria (15 listed)
- Patients under 18 years old,
- Patients older 65 years old,
- Teeth with previously undergone root canal treatment,
- Complicating systemic diseases,
- Allergies o local anesthetic agents,
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 |
|---|---|---|
| occlusal reductionAlso: occlusal reduction procedureOcclusal reduction is a procedure that applied patients for different aims. One of these aims is pain relief after endodontic treatment and there are some studies about this topic however, there is no consensus about it. This discrepency could be related to differences of the inclusion criteria for this reason this study aimed to get a reliable result. | Other | Occlusal reduction, |
Primary outcome
Effect of occlusal reduction on pain relief
Time frame: from enrollment to the end each patient called for a week to understand their pain levels and each of them called after 1st, 3th, 7th days treatment.
This study was primarily aim to understand the effect of occlusal reduction on pain relief after root canal treatment of irriversible pulpitis. After root canal treatment patients were called to estimate their pain levels. A 0-3 rate verbal rating scale was used for this aim. 0: no discomfort or pain 1. mild pain (not requiring analgesic medication) 2. moderate pain (requiring analgesic medication) 3. severe pain (interfering with physical activity and minimally responsive to analgesics)
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 1 May 2025.
- Background: PubMed 32418236Ahmed YE, Emara RS, Sarhan SM, El Boghdadi RM, El-Bayoumi MAA, El-Far HMM, Sabet NE, Abou El-Nasr HM, Gawdat SI, Amin SAW. Post-treatment endodontic pain following occlusal reduction in mandibular posterior teeth with symptomatic irreversible pulpitis and sensitivity to percussion: a single-centre randomized controlled trial. Int Endod J. 2020 Sep;53(9):1170-1180. doi: 10.1111/iej.13328. Epub 2020 Jun 15.
- Results publication: PubMed 23228248Parirokh M, Rekabi AR, Ashouri R, Nakhaee N, Abbott PV, Gorjestani H. Effect of occlusal reduction on postoperative pain in teeth with irreversible pulpitis and mild tenderness to percussion. J Endod. 2013 Jan;39(1):1-5. doi: 10.1016/j.joen.2012.08.008. Epub 2012 Sep 29.
- Results publication: PubMed 30171777Emara RS, Abou El Nasr HM, El Boghdadi RM. Evaluation of postoperative pain intensity following occlusal reduction in teeth associated with symptomatic irreversible pulpitis and symptomatic apical periodontitis: a randomized clinical study. Int Endod J. 2019 Mar;52(3):288-296. doi: 10.1111/iej.13012. Epub 2018 Sep 28.
- Results publication: PubMed 9693578Rosenberg PA, Babick PJ, Schertzer L, Leung A. The effect of occlusal reduction on pain after endodontic instrumentation. J Endod. 1998 Jul;24(7):492-6. doi: 10.1016/S0099-2399(98)80054-X.
- Results publication: PubMed 31638301Nguyen-Nhon D, Nagendrababu V, Pulikkotil SJ, Rossi-Fedele G. Effect of occlusal reduction on postendodontic pain: A systematic review and meta-analysis of randomised clinical trials. Aust Endod J. 2020 Aug;46(2):282-294. doi: 10.1111/aej.12380. Epub 2019 Oct 22.
- Results publication: PubMed 17956561Sathorn C, Parashos P, Messer H. The prevalence of postoperative pain and flare-up in single- and multiple-visit endodontic treatment: a systematic review. Int Endod J. 2008 Feb;41(2):91-9. doi: 10.1111/j.1365-2591.2007.01316.x. Epub 2007 Oct 23.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing occlusal reduction in people with Irriversible Pulpitis, run by Sakarya 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 15 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 1 May 2025. 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?
Effect of occlusal reduction on pain relief (time frame: from enrollment to the end each patient called for a week to understand their pain levels and each of them called after 1st, 3th, 7th days treatment.). 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 NCT06953856, which also lists 6 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 1 May 2025.