Postoperative PainNCT03117062
Occlusal Reduction and Postoperative Pain
A study testing occlusal reduction in people with Postoperative Pain, run by Cairo University.
Trial summary
The purpose of this randomized clinical study was to evaluate the impact of occlusal reduction on the incidences of post-instrumentation and post-obturation pain. Forty four patients were included in this study. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- occlusal reduction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Jan 2015
- 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
- healthy adults of 18-50 years. The diagnosis of symptomatic irreversible pulpitis with symptomatic apical periodontitis in a posterior mandibular tooth was confirmed by history of chief complaint of moderate to severe lingering sharp throbbing pain with pain on biting, clinical examination revealing positive response to an electrical pulp tester and tenderness to percussion on tapping the tooth with the end of a mirror handle, and radiographic examination showing posterior tooth with no apical radiolucency or slight widening of lamina dura.
Who cannot join
- pregnant women, patients who reported bruxism or clenching, or patients who have administrated analgesics preoperatively during the past 12 hours that might alter their pain perception. Teeth that had no occlusal contact, no sensitivity to percussion, association with swelling or fistulous tract, greater than grade I mobility, or no possible restorability were also excluded.
About this study
Official title: Evaluation of Postoperative Pain Intensity Following Occlusal Reduction in Teeth Associated With Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis: A Randomized Clinical Study
The purpose of this randomized clinical study was to evaluate the impact of occlusal reduction on the incidences of post-instrumentation and post-obturation pain. Forty four patients were included in this study. Inclusion criteria were posterior mandibular teeth having symptomatic irreversible pulpitis and symptomatic apical periodontitis. Patients were randomized into two equal groups. In the intervention group the functional and nonfunctional cusps were reduced until absence of contact was confirmed, while in the control group the occlusal surfaces were left intact. Standard endodontic treatment was performed in two visits using rotary nickel titanium files for shaping, 2.5% sodium hypochlorite for cleaning and lateral condensation technique with resin sealer for obturation. Pain was assessed preoperatively, then after 6, 12, 24 and 48 hours following instrumentation, then after 6 and 12 hours following obturation. Visual Analogue Scale (VAS) was used as the primary outcome measure. Patients were given a placebo to be administrated in case of severe pain and ibuprofen 400mg was prescribed in case of persistent pain.
Read the detailed description
Recruitment of the study participants was done from the outpatient clinic of the Endodontic Department of the Faculty of Oral and Dental Medicine, Cairo University.
Randomization was done to assign participants to the study groups by chance and not choice. 44 numbers were generated and randomly allocated to either intervention or control group on a table using Microsoft Office Excel 2010. Each participant was given a number from 1 to 44 according to his turn in enrollment in the study.
Root canal treatment was completed in two visits. Before treatment, each patient was given pain scale chart and was asked to record their pain level. The tooth was anesthetized using inferior alveolar nerve block technique by local anesthesia of 1.8 - 3.6 ml of 2% Mepivacaine HCl. The access cavity preparation was performed using round carbide bur and Endo-z bur. After access cavity in the intervention group, all occlusal contacts on the functional and non-functional cusps as well as on the marginal ridges were reduced using a wheel diamond bur. Absence of contact was confirmed using an articulating paper. In the control group, all occlusal contacts were left intact. The tooth was then properly isolated with rubber dam. The patency of the root canals was confirmed using stainless steel hand K-files size #10 and #15. Working length was determined using an electronic apex locator and confirmed radiographically to be 1 mm shorter than radiographic apex. Mechanical preparation was done by crown-down technique using rotary Revo-S instruments and Ethylene Diamine Tetra Aceticacid gel as a lubricant. The canals were thoroughly irrigated using 3ml of 2.5% sodium hypochlorite following each instrument. After dryness of the canals using paper points, a cotton pellet was placed in the pulp chamber and the access cavity was sealed with a temporary filling. After 7 days, the root canals were obturated with lateral condensation technique using 0.04 taper gutta-percha and AdSeal resin-based root canal sealer.
Degree of postoperative pain was measured using visual analogue scale (VAS) after 6, 12, 24 and 48 hours after instrumentation then at 6 and 12 hours after obturation. The VAS consists of a 10-cm line anchored by two extremes "No pain" and "pain as bad as could be". The patients were asked to choose the mark that represents their level of pain. Pain level was assigned to one of four categorical scores: 1, None(0); 2,Mild(1-3); 3,Moderate(4-6); 4,Severe(7-10) 10.
In case of moderate to severe postoperative pain, the patients were instructed to take a capsule of placebo given to him/her at the end of each visit. In case of persistent pain, patients were allowed to take Ibuprofen 400mg. The incidence of placebo intake and number of analgesic tablets taken were recorded by the patients.
- Conditions
- Postoperative Pain
- Being tested
- occlusal reduction
- 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 relief
relief of occlusion following endodontic treatment
| Study group | Role | What they receive |
|---|---|---|
| Occlusal Reduction | Experimental | performing occlusal reduction on functional cusps until abscence of contact was confirmed Receives: Other: occlusal reduction |
| non-occlusal reduction | No intervention | occlusal surface left intact |
What is being measured
The primary outcome is the main question the study is designed to answer.
postinstrumentation pain
postoperative pain was measured using visual analogue scale (VAS) following root canal instrumentation
Measured: up to 48 hours following instrumentation
postobturation pain
postoperative pain was measured using visual analogue scale (VAS) following root canal obturation
Measured: upto 24 hours following obturation
Secondary outcomes (1)
incidence of placebo and analgesic intake
The incidence of placebo intake and number of analgesic tablets taken were recorded by the patients.
Measured: up to 48 hours following each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study startSep 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Sameeh Emara, Cairo University
- Investigators
- Radwa S Emara, Masters, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117062
- Sponsor's protocol ID
- CEBC-CU-2015-15-166
- Status last verified
- Apr 2017
- First submitted
- 6 Apr 2017
- Last updated
- 17 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD data are confidential and secured. Only accessed by principal investigator and supervisors
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postoperative Pain Intensity Following Occlusal Reduction in Teeth Associated With Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT03117062
- Acronym / sponsor ID
- CEBC-CU-2015-15-166
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 17 Apr 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.
The purpose of this randomized clinical study was to evaluate the impact of occlusal reduction on the incidences of post-instrumentation and post-obturation pain. Forty four patients were included in this study. Inclusion criteria were posterior mandibular teeth having symptomatic irreversible pulpitis and symptomatic apical periodontitis. Patients were randomized into two equal groups. In the intervention group the functional and nonfunctional cusps were reduced until absence of contact was confirmed, while in the control group the occlusal surfaces were left intact. Standard endodontic treatment was performed in two visits using rotary nickel titanium files for shaping, 2.5% sodium hypochlorite for cleaning and lateral condensation technique with resin sealer for obturation. Pain was assessed preoperatively, then after 6, 12, 24 and 48 hours following instrumentation, then after 6 and 12 hours following obturation. Visual Analogue Scale (VAS) was used as the primary outcome measure. Patients were given a placebo to be administrated in case of severe pain and ibuprofen 400mg was prescribed in case of persistent pain.
Detailed description
Recruitment of the study participants was done from the outpatient clinic of the Endodontic Department of the Faculty of Oral and Dental Medicine, Cairo University.
Randomization was done to assign participants to the study groups by chance and not choice. 44 numbers were generated and randomly allocated to either intervention or control group on a table using Microsoft Office Excel 2010. Each participant was given a number from 1 to 44 according to his turn in enrollment in the study.
Root canal treatment was completed in two visits. Before treatment, each patient was given pain scale chart and was asked to record their pain level. The tooth was anesthetized using inferior alveolar nerve block technique by local anesthesia of 1.8 - 3.6 ml of 2% Mepivacaine HCl. The access cavity preparation was performed using round carbide bur and Endo-z bur. After access cavity in the intervention group, all occlusal contacts on the functional and non-functional cusps as well as on the marginal ridges were reduced using a wheel diamond bur. Absence of contact was confirmed using an articulating paper. In the control group, all occlusal contacts were left intact. The tooth was then properly isolated with rubber dam. The patency of the root canals was confirmed using stainless steel hand K-files size #10 and #15. Working length was determined using an electronic apex locator and confirmed radiographically to be 1 mm shorter than radiographic apex. Mechanical preparation was done by crown-down technique using rotary Revo-S instruments and Ethylene Diamine Tetra Aceticacid gel as a lubricant. The canals were thoroughly irrigated using 3ml of 2.5% sodium hypochlorite following each instrument. After dryness of the canals using paper points, a cotton pellet was placed in the pulp chamber and the access cavity was sealed with a temporary filling. After 7 days, the root canals were obturated with lateral condensation technique using 0.04 taper gutta-percha and AdSeal resin-based root canal sealer.
Degree of postoperative pain was measured using visual analogue scale (VAS) after 6, 12, 24 and 48 hours after instrumentation then at 6 and 12 hours after obturation. The VAS consists of a 10-cm line anchored by two extremes "No pain" and "pain as bad as could be". The patients were asked to choose the mark that represents their level of pain. Pain level was assigned to one of four categorical scores: 1, None(0); 2,Mild(1-3); 3,Moderate(4-6); 4,Severe(7-10) 10.
In case of moderate to severe postoperative pain, the patients were instructed to take a capsule of placebo given to him/her at the end of each visit. In case of persistent pain, patients were allowed to take Ibuprofen 400mg. The incidence of placebo intake and number of analgesic tablets taken were recorded by the patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Occlusal Reduction | Experimental | Other: occlusal reductionperforming occlusal reduction on functional cusps until abscence of contact was confirmed |
| non-occlusal reduction | No intervention | –occlusal surface left intact |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy adults of 18-50 years. The diagnosis of symptomatic irreversible pulpitis with symptomatic apical periodontitis in a posterior mandibular tooth was confirmed by history of chief complaint of moderate to severe lingering sharp throbbing pain with pain on biting, clinical examination revealing positive response to an electrical pulp tester and tenderness to percussion on tapping the tooth with the end of a mirror handle, and radiographic examination showing posterior tooth with no apical radiolucency or slight widening of lamina dura.
Key exclusion criteria (1 listed)
- pregnant women, patients who reported bruxism or clenching, or patients who have administrated analgesics preoperatively during the past 12 hours that might alter their pain perception. Teeth that had no occlusal contact, no sensitivity to percussion, association with swelling or fistulous tract, greater than grade I mobility, or no possible restorability were also excluded.
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 reliefrelief of occlusion following endodontic treatment | Other | Occlusal Reduction |
Primary outcome
postinstrumentation pain
Time frame: up to 48 hours following instrumentation
postoperative pain was measured using visual analogue scale (VAS) following root canal instrumentation
postobturation pain
Time frame: upto 24 hours following obturation
postoperative pain was measured using visual analogue scale (VAS) following root canal obturation
1 secondary outcome
incidence of placebo and analgesic intake
Time frame: up to 48 hours following each visit
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 17 Apr 2017.
- Individual participant dataSharing planned: No. IPD data are confidential and secured. Only accessed by principal investigator and supervisors
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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.
Radwa S Emara, Masters principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing occlusal reduction in people with Postoperative Pain, 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 1 inclusion and 1 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 17 Apr 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. 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?
postinstrumentation pain (time frame: up to 48 hours following instrumentation). 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 17 Apr 2017; AzTrials last refreshed its copy on 27 Oct 2026.