Post Operative PainNCT05306535
Effect of Occlusal Reduction on Relief of Pain and Sensitivity to Percussion in Patients With Irreversible Pulpitis
A study testing Occlusal reduction in people with Post Operative Pain and Post-Op Complication, run by Altamash Institute of Dental Medicine at 1 site in Pakistan.
Trial summary
One of the most important aspects of endodontic practice is to abate pain during and post root canal treatment. An endodontist by all means should provide a painless endodontic treatment to their patients. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain, Post-Op Complication
- What is being tested?
- Occlusal reduction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2022to 30 Jun 2022
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No medical history
- patients suffering from Symptomatic Irreversible Pulpitis
- patients suffering from Apical Periodontitis
- patients requiring porcelain fused to metal crown
Who cannot join
- Patients who were not suitable for conventional root canal treatment
- multirooted teeth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Occlusal Reduction on Relief of Pain and Sensitivity to Percussion in Patients With Irreversible Pulpitis and Symptomatic Apical Periodontitis Treated in a Single Visit- a Randomized Clinical Trial
One of the most important aspects of endodontic practice is to abate pain during and post root canal treatment. An endodontist by all means should provide a painless endodontic treatment to their patients. This study is carried out to determine the effect of occlusal reduction on relief of pain and percussion in patients with irreversible pulpitis and symptomatic apical periodontitis treated in a single visit root canal treatment. Pain will be assessed preoperatively and then post operatively after completion of the root canal at 6 hours, 12 hours, 24 hours, 48 hours and 72 hours following obturation of root canal.
Read the detailed description
The objective of this randomized clinical trial is to evaluate the impact of occlusal reduction on the incidence of post obturation pain. 56 patients will be allocated randomly into 2 groups keeping 28 patients in each group which will meet the inclusion criteria of the study, patients diagnosed with symptomatic irreversible pulpitis and symptomatic apical periodontitis and requiring porcelain fused to metal crown with age ranging from 18 to 50 years. In the interventional group 2mm reduction will be done and assessment will be done to confirm the absence of occlusal contact while in control group no modification will be carried out on the occlusal surface. Single visit endodontic treatment will be carried out with 2.5% sodium hypochlorite for disinfection of the canal followed by crown down technique using rotary nickel titanium files for shaping the canals followed by obturating the canals with lateral condensation technique.
Pain will be assessed preoperatively and then post operatively at 6 hours, 12 hours, 24 hours, 48 hours and 72 hours following obturation of root canal. Visual Analogue Scale (VAS) will be used as a primary outcome measure.The VAS consists of a 10-cm line having two extremes NO PAIN and Extreme pain. Patients will be asked to choose the mark that represents their level of pain at the intervals mentioned above . Pain level are assigned to one of four categorical scores
1, None(0); 2, Mild (1-3) ; 3 Moderate (4-6); 4, Severe (7-10) 10. Tenderness to percussion will be evaluated postoperatively at 48 hour with readings either positive to tenderness or negative to tenderness Positive to tenderness will evaluate treatment not effective Negative to tenderness at 48 hour post obturation will evaluate treatment effectiveness Patients will be given placebo for administration in case severe pain and ibuprofen 400mg if the pain persisted. Documentation of intake of either placebo or analgesic will be done by the patient.
- Conditions
- Post Operative Pain, Post-Op Complication
- Being tested
- Occlusal reduction
- Keywords
- Occlusal reduction
- Medical subject headings
- Pain, Postoperative, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occlusal reductionProcedure or surgery
Occlusal reduction of the experimental single rooted tooth after root canal completion will be done to evaluation reduction in postoperative pain and sensitivity to percussion
| Study group | Role | What they receive |
|---|---|---|
| occlusal reduction | Experimental | Performing occlusal reduction on the experimental tooth until absence of occlusal contact is confirmed following completion of the endodontic treatment Receives: Procedure: Occlusal reduction |
| control | No intervention | No occlusal reduction or modification of the occlusal anatomy will be performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Obturation pain
Postobturation pain is measured using the visual analogue scale(VAS) with readings from 0-10 where 0 represents no pain and 10 represents the worst pain measured.
Measured: 6 hours upto 48 hours following obturation
Tenderness to percussion
Tenderness to percussion will be evaluated (score 0: no pain, score 1: slight pain score 2: severe pain)
Measured: At 48 hours post completion of the root canal treatment
Secondary outcomes (1)
Incidence of placebo and analgesic intake
The incidence of placebo and number analgesic taken will be recorded by the patient
Measured: from 6 hours up to 48 hours following completion of root canal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start1 Apr 2022
- Primary completion1 Apr 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altamash Institute of Dental Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hira Abbasi, Altamash Institute of Dental Medicine
- Investigators
- Hira Danish, Principal investigator, Employee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306535
- Sponsor's protocol ID
- Endodontic Pain
- Status last verified
- Aug 2022
- First submitted
- 15 Mar 2022
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Occlusal Reduction on Relief of Pain and Sensitivity to Percussion in Patients With Irreversible Pulpitis and Symptomatic Apical Periodontitis Treated in a Single Visit- a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05306535
- Acronym / sponsor ID
- Endodontic Pain
- Conditions
- Post Operative Pain, Post-Op Complication
- Keywords
- Occlusal reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Altamash Institute of Dental MedicineUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 1 Apr 2022 (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.
One of the most important aspects of endodontic practice is to abate pain during and post root canal treatment. An endodontist by all means should provide a painless endodontic treatment to their patients. This study is carried out to determine the effect of occlusal reduction on relief of pain and percussion in patients with irreversible pulpitis and symptomatic apical periodontitis treated in a single visit root canal treatment. Pain will be assessed preoperatively and then post operatively after completion of the root canal at 6 hours, 12 hours, 24 hours, 48 hours and 72 hours following obturation of root canal.
Detailed description
The objective of this randomized clinical trial is to evaluate the impact of occlusal reduction on the incidence of post obturation pain. 56 patients will be allocated randomly into 2 groups keeping 28 patients in each group which will meet the inclusion criteria of the study, patients diagnosed with symptomatic irreversible pulpitis and symptomatic apical periodontitis and requiring porcelain fused to metal crown with age ranging from 18 to 50 years. In the interventional group 2mm reduction will be done and assessment will be done to confirm the absence of occlusal contact while in control group no modification will be carried out on the occlusal surface. Single visit endodontic treatment will be carried out with 2.5% sodium hypochlorite for disinfection of the canal followed by crown down technique using rotary nickel titanium files for shaping the canals followed by obturating the canals with lateral condensation technique.
Pain will be assessed preoperatively and then post operatively at 6 hours, 12 hours, 24 hours, 48 hours and 72 hours following obturation of root canal. Visual Analogue Scale (VAS) will be used as a primary outcome measure.The VAS consists of a 10-cm line having two extremes NO PAIN and Extreme pain. Patients will be asked to choose the mark that represents their level of pain at the intervals mentioned above . Pain level are assigned to one of four categorical scores
1, None(0); 2, Mild (1-3) ; 3 Moderate (4-6); 4, Severe (7-10) 10. Tenderness to percussion will be evaluated postoperatively at 48 hour with readings either positive to tenderness or negative to tenderness Positive to tenderness will evaluate treatment not effective Negative to tenderness at 48 hour post obturation will evaluate treatment effectiveness Patients will be given placebo for administration in case severe pain and ibuprofen 400mg if the pain persisted. Documentation of intake of either placebo or analgesic will be done by the patient.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| occlusal reduction | Experimental | Procedure: Occlusal reductionPerforming occlusal reduction on the experimental tooth until absence of occlusal contact is confirmed following completion of the endodontic treatment |
| control | No intervention | –No occlusal reduction or modification of the occlusal anatomy will be performed |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- No medical history
- patients suffering from Symptomatic Irreversible Pulpitis
- patients suffering from Apical Periodontitis
- patients requiring porcelain fused to metal crown
Key exclusion criteria (2 listed)
- Patients who were not suitable for conventional root canal treatment
- multirooted teeth
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 reductionOcclusal reduction of the experimental single rooted tooth after root canal completion will be done to evaluation reduction in postoperative pain and sensitivity to percussion | Procedure or surgery | occlusal reduction |
Primary outcome
Post Obturation pain
Time frame: 6 hours upto 48 hours following obturation
Postobturation pain is measured using the visual analogue scale(VAS) with readings from 0-10 where 0 represents no pain and 10 represents the worst pain measured.
Tenderness to percussion
Time frame: At 48 hours post completion of the root canal treatment
Tenderness to percussion will be evaluated (score 0: no pain, score 1: slight pain score 2: severe pain)
1 secondary outcome
Incidence of placebo and analgesic intake
Time frame: from 6 hours up to 48 hours following completion of root canal
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 24 Aug 2022.
- 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.
Hira Danish principal investigator
Employee
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 Post Operative Pain and Post-Op Complication, run by Altamash Institute of Dental Medicine at 1 site in Pakistan.
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 2 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 24 Aug 2022. 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 Pakistan. 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?
Post Obturation pain (time frame: 6 hours upto 48 hours following obturation). 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 24 Aug 2022.