Evaluate Occlusal Reduction on Post-operative PainNCT03189771
Effect of Occlusal Reduction on Post-operative Pain
A study testing occlusal surface reduction in people with Evaluate Occlusal Reduction on Post-operative Pain and Teeth With Symptomatic Irreversible Pulpitis, run by Cairo University.
Trial summary
effect of occlusal reduction on post-operative pain is evaluated after single visit root canal treatment in upper and lower molar teeth in patients with sypmtomatic irreversible pulpitis and apical periondontis Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Evaluate Occlusal Reduction on Post-operative Pain, Teeth With Symptomatic Irreversible Pulpitis, Apical Periodontitis
- What is being tested?
- occlusal surface reduction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 27 Jun 2017to 30 Jul 2018
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient's age between 20-50 years with no sex predilection.
- Medically free patients.
- Patients suffering from symptomatic irreversible pulpitis with symptomatic apical periodontitis in maxillary and mandibular molars with:
- Preoperative pain.
- Vital pulp.
- Sensitivity to percussion.
- Occlusal contact with the opposing teeth.
- Normal periapical radiographic appearance or slight widening in the periodontal membrane space.
Who cannot join
- Pregnant females.
- Patients having a significant systemic disorder.
- Patients who had administered analgesics or antibiotics during the last 12 hours preoperatively.
- Patients having bruxism or clenching.
- Teeth having :
- No occlusal contact.
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- No sensitivity to percussion.
- Association with swelling or fistulous tract.
- Acute or chronic peri-apical abscess.
- Greater than grade I mobility.
- Pocket depth greater than 5mm.
- No possible restorability.
- Previous endodontic treatment
About this study
Official title: Effect of Occlusal Reduction on Post-operative Pain in Patients With Irreversible Pulpitis and Symptomatic Apical Periodontitis Treated in a Single-visit: A Randomized Clinical Trial
effect of occlusal reduction on post-operative pain is evaluated after single visit root canal treatment in upper and lower molar teeth in patients with sypmtomatic irreversible pulpitis and apical periondontis
- Conditions
- Evaluate Occlusal Reduction on Post-operative Pain, Teeth With Symptomatic Irreversible Pulpitis, Apical Periodontitis
- Being tested
- occlusal surface reduction
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
occlusal surface reductionProcedure or surgery
occlusal surface reduction after single visit root canal treatment
| Study group | Role | What they receive |
|---|---|---|
| occlusal surface reduction | Experimental | occlusal surface reduction after single visit root canal treatment Receives: Procedure: occlusal surface reduction |
| no occlusal surface reduction | Placebo comparator | No occlusal surface reduction after single visit root canal treatment Receives: Procedure: occlusal surface reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
pre-operative pain before single visit root canal treatment by NRS (numerical rating scale)
Primary outcome will be assessed by NRS (numerical rating scale), the unit of measurement is categorical.The scale is from (0-10) (1-3) Mild pain (4-6) Moderate pain (7-10) Severe pain
Measured: Baseline
post-operative pain after single visit root canal treatment by NRS (numerical rating scale)
Primary outcome will be assessed by NRS (numerical rating scale), the unit of measurement is categorical.The scale is from (0-10) (1-3) Mild pain (4-6) Moderate pain (7-10) Severe pain
Measured: after treatment by 6 hours
post-operative pain after single visit root canal treatment by NRS (numerical rating scale)
Primary outcome will be assessed by NRS (numerical rating scale), the unit of measurement is categorical.The scale is from (0-10) (1-3) Mild pain (4-6) Moderate pain (7-10) Severe pain
Measured: after treatment by 12 hours
post-operative pain after single visit root canal treatment by NRS (numerical rating scale)
Primary outcome will be assessed by NRS (numerical rating scale), the unit of measurement is categorical.The scale is from (0-10) (1-3) Mild pain (4-6) Moderate pain (7-10) Severe pain
Measured: after treatment by 24 hours
post-operative pain after single visit root canal treatment by NRS (numerical rating scale)
Primary outcome will be assessed by NRS (numerical rating scale), the unit of measurement is categorical.The scale is from (0-10) (1-3) Mild pain (4-6) Moderate pain (7-10) Severe pain
Measured: after treatment by 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start27 Jun 2017 (estimated)
- Primary completion1 Jul 2018 (estimated)
- Study completion30 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluate Occlusal Reduction on Post-operative PainStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fadwa sheesh, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189771
- Sponsor's protocol ID
- evidence comittee
- Status last verified
- Jun 2017
- First submitted
- 9 Jun 2017
- Last updated
- 16 Jun 2017
- 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 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Occlusal Reduction on Post-operative Pain in Patients With Irreversible Pulpitis and Symptomatic Apical Periodontitis Treated in a Single-visit: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03189771
- Acronym / sponsor ID
- evidence comittee
- Conditions
- Evaluate Occlusal Reduction on Post-operative Pain, Teeth With Symptomatic Irreversible Pulpitis, Apical Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 27 Jun 2017 (estimated)
- Primary completion
- 1 Jul 2018 (estimated)
- Study completion
- 30 Jul 2018 (estimated)
- First posted
- 16 Jun 2017 (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.
effect of occlusal reduction on post-operative pain is evaluated after single visit root canal treatment in upper and lower molar teeth in patients with sypmtomatic irreversible pulpitis and apical periondontis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| occlusal surface reduction | Experimental | Procedure: occlusal surface reductionocclusal surface reduction after single visit root canal treatment |
| no occlusal surface reduction | Placebo comparator | Procedure: occlusal surface reductionNo occlusal surface reduction after single visit root canal treatment |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patient's age between 20-50 years with no sex predilection.
- Medically free patients.
- Patients suffering from symptomatic irreversible pulpitis with symptomatic apical periodontitis in maxillary and mandibular molars with:
Key exclusion criteria (13 listed)
- Pregnant females.
- Patients having a significant systemic disorder.
- Patients who had administered analgesics or antibiotics during the last 12 hours preoperatively.
- Patients having bruxism or clenching.
- Teeth having :
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 surface reductionocclusal surface reduction after single visit root canal treatment | Procedure or surgery | no occlusal surface reduction, occlusal surface reduction |
Primary outcome
pre-operative pain before single visit root canal treatment by NRS (numerical rating scale)
Time frame: Baseline
Primary outcome will be assessed by NRS (numerical rating scale), the unit of measurement is categorical.The scale is from (0-10) (1-3) Mild pain (4-6) Moderate pain (7-10) Severe pain
post-operative pain after single visit root canal treatment by NRS (numerical rating scale)
Time frame: after treatment by 6 hours
Primary outcome will be assessed by NRS (numerical rating scale), the unit of measurement is categorical.The scale is from (0-10) (1-3) Mild pain (4-6) Moderate pain (7-10) Severe pain
post-operative pain after single visit root canal treatment by NRS (numerical rating scale)
Time frame: after treatment by 12 hours
Primary outcome will be assessed by NRS (numerical rating scale), the unit of measurement is categorical.The scale is from (0-10) (1-3) Mild pain (4-6) Moderate pain (7-10) Severe pain
post-operative pain after single visit root canal treatment by NRS (numerical rating scale)
Time frame: after treatment by 24 hours
Primary outcome will be assessed by NRS (numerical rating scale), the unit of measurement is categorical.The scale is from (0-10) (1-3) Mild pain (4-6) Moderate pain (7-10) Severe pain
post-operative pain after single visit root canal treatment by NRS (numerical rating scale)
Time frame: after treatment by 48 hours
Primary outcome will be assessed by NRS (numerical rating scale), the unit of measurement is categorical.The scale is from (0-10) (1-3) Mild pain (4-6) Moderate pain (7-10) Severe pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing occlusal surface reduction in people with Evaluate Occlusal Reduction on Post-operative Pain and Teeth With Symptomatic Irreversible Pulpitis, run by Cairo University.
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 8 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
pre-operative pain before single visit root canal treatment by NRS (numerical rating scale) (time frame: Baseline). The study lists 5 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 16 Jun 2017.