Postoperative PainEarly Phase 1NCT03199482
Effect of Pretreatment Dexamethazone on Pain and Success of Nerve Block
A Early Phase 1 study testing Dexamethasone Oral Tablet in people with Postoperative Pain, run by Cairo University at 1 site in Egypt.
Trial summary
A Comparative Evaluation of the effect of pretreatment dexamethasone versus placebo on post-endodontic pain and success of inferior alveolar nerve block in Mandibular molars with symptomatic Irreversible Pulpitis: A Blinded Randomized Clinical Trial Therapeutic study Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Dexamethasone Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jul 2017to 7 Jul 2018
- Phase
- Early Phase 1
- 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
- Patients in good health with no systemic disease (American Society of Anesthesiologists Class II)
- Patients having symptomatic irreversible pulpitis in one of their mandibular molars
- Age range is between 20 and 50 years
- Patients who can understand the categorical tool (points) for measurement
- Patients able to sign informed consent
Who cannot join
- Patients with positive percussion test
- Patients having history of necrosis with or without apical pathosis
- Patients have sinus tract or fistula extraoral or intraoral
- Patients having active pain in more than one molar
- Patients who had taken analgesics in the 12 hours preceding the preparation.
- Complicating systemic disease
- Subjects with allergies and hypersensitivity to or unable to take dexamethasone
- Teeth with grade 2 or 3 mobility
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry
Cairo, Manyal, 02
mai mohamed safei eldin, bachelore, 0102232932 ext. 2012, mai.safei247@gmail.com
About this study
Official title: A Comparative Evaluation of Effect of Dexamethazone on Postendodontic Pain and Success of Inferior Alveolar Nerve Block in Mandibular Molars With Symptomatic Irreversible Pulpitis
A Comparative Evaluation of the effect of pretreatment dexamethasone versus placebo on post-endodontic pain and success of inferior alveolar nerve block in Mandibular molars with symptomatic Irreversible Pulpitis: A Blinded Randomized Clinical Trial Therapeutic study
Read the detailed description
Participants, Interventions and Outcome
Setting:
Patients are of the clinic of endodontics at the faculty of oral and dental medicine, Cairo University, Urban area, Cairo governorate, Egypt.
- The dental Unit is Adec 200 U.S.A.
- The x-ray Machine is ViVi, S.r.I, Italy
- The x-ray films are Kodac, speed D, size 2.
- The operators are master degree students in the department of Endodontics.
- No dental assistant
- Time: 2017-2016
Procedure steps:
- Patients are asked to rate the pain level on numerical rating scale before the administration of drug to get the baseline record for the pain preoperatively.
- Thirty minutes before the endodontic procedure,dexamethasone (0.5 mg) or a placebo will be administered.Root canal therapy in all cases was completed in a single visit.
- After explanation of the treatment procedures (according to individual needs), the tooth will be anesthetized by an inferior alveolar nerve block (1.8 ml mepivacaine hydrochloride 2% 1: 100,000 epinephrine) using a side loading aspirating syringe and 27-gauge long needle.
- At 15-minutes post injection, access cavity will be performed using round bur size 4 and endo-z bur and the pain is recorded .
- Tooth is then isolated using rubber dam to prevent introduction of saliva and Bactria from the oral cavity.
- Checking the patency of the canal with K- file size 10 taper 0.02, extirpation of pulp with H-file size 15 taper 0.02 with recording the pain.
- Cleaning and shaping will be performed with a hybrid technique using hand K-files and rotary files for all teeth.
- Irrigation will be performed with 2.5% NaOCl after each instrument in all cases. At the end of instrumentation, the final irrigation will made by saline.
- After drying the canals with sterile paper points, they will be coated with AD-Seal sealer and obturated with gutta-percha using the lateral condensation technique.
- The tooth will be then temporized by using cavit temporary filling and reduced from occlusion.
- A rescue medication (ibuprofen) will be prescribed and the patients will be instructed to take it only if they experienced severe pain postoperatively. If rescue medication will be taken within the 48 hours after the treatment, then the patient will be excluded from the study.
Patients will be asked to make a mark on the point that represents level of perceived pain. (before the commencement of any treatment [baseline score]; at access and pulp extirpation, immediately after treatment completion; and 6, 12, 24, and 48 hours after the commencement of treatment). All subjects will be recalled after 2 days to return the pain diary and for a clinical evaluation.
- Conditions
- Postoperative Pain
- Being tested
- Dexamethasone Oral Tablet, Placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone Oral TabletDrug
single dose of tablet 0.5 mg dexamethasone given to patients before starting of root canal treatment by 30 minutes or placebo
PlaceboDrug
Placebo will be administrated 30 minutes before start of root canal treatment
| Study group | Role | What they receive |
|---|---|---|
| Drug dexamethasone | Active comparator | preoperative single dose of dexamethasone 0.5 mg oral tablet given to patients before starting of root canal treatment by 30 minutes. Receives: Drug: Dexamethasone Oral Tablet |
| Placebo | Placebo comparator | Placebo will be administrated to patients before stating of root canal treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Numerical rating scale
Measured: 48 hours
Secondary outcomes (1)
success of inferior alveolar nerve block
Numerical rating scale
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start12 Jul 2017 (estimated)
- Primary completion12 Oct 2017 (estimated)
- Study completion7 Jul 2018 (estimated)
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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- dexamethazone
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Mohamed Safei Eldin Sayed, Cairo University
- Investigators
- Manar Hamouda, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03199482
- Sponsor's protocol ID
- kinda
- Status last verified
- Jun 2017
- First submitted
- 18 Jun 2017
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Evaluation of Effect of Dexamethazone on Postendodontic Pain and Success of Inferior Alveolar Nerve Block in Mandibular Molars With Symptomatic Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT03199482
- Acronym / sponsor ID
- kinda
- Conditions
- Postoperative Pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Jul 2017 (estimated)
- Primary completion
- 12 Oct 2017 (estimated)
- Study completion
- 7 Jul 2018 (estimated)
- First posted
- 27 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.
A Comparative Evaluation of the effect of pretreatment dexamethasone versus placebo on post-endodontic pain and success of inferior alveolar nerve block in Mandibular molars with symptomatic Irreversible Pulpitis: A Blinded Randomized Clinical Trial Therapeutic study
Detailed description
Participants, Interventions and Outcome
Setting:
Patients are of the clinic of endodontics at the faculty of oral and dental medicine, Cairo University, Urban area, Cairo governorate, Egypt.
- The dental Unit is Adec 200 U.S.A.
- The x-ray Machine is ViVi, S.r.I, Italy
- The x-ray films are Kodac, speed D, size 2.
- The operators are master degree students in the department of Endodontics.
- No dental assistant
- Time: 2017-2016
Procedure steps:
- Patients are asked to rate the pain level on numerical rating scale before the administration of drug to get the baseline record for the pain preoperatively.
- Thirty minutes before the endodontic procedure,dexamethasone (0.5 mg) or a placebo will be administered.Root canal therapy in all cases was completed in a single visit.
- After explanation of the treatment procedures (according to individual needs), the tooth will be anesthetized by an inferior alveolar nerve block (1.8 ml mepivacaine hydrochloride 2% 1: 100,000 epinephrine) using a side loading aspirating syringe and 27-gauge long needle.
- At 15-minutes post injection, access cavity will be performed using round bur size 4 and endo-z bur and the pain is recorded .
- Tooth is then isolated using rubber dam to prevent introduction of saliva and Bactria from the oral cavity.
- Checking the patency of the canal with K- file size 10 taper 0.02, extirpation of pulp with H-file size 15 taper 0.02 with recording the pain.
- Cleaning and shaping will be performed with a hybrid technique using hand K-files and rotary files for all teeth.
- Irrigation will be performed with 2.5% NaOCl after each instrument in all cases. At the end of instrumentation, the final irrigation will made by saline.
- After drying the canals with sterile paper points, they will be coated with AD-Seal sealer and obturated with gutta-percha using the lateral condensation technique.
- The tooth will be then temporized by using cavit temporary filling and reduced from occlusion.
- A rescue medication (ibuprofen) will be prescribed and the patients will be instructed to take it only if they experienced severe pain postoperatively. If rescue medication will be taken within the 48 hours after the treatment, then the patient will be excluded from the study.
Patients will be asked to make a mark on the point that represents level of perceived pain. (before the commencement of any treatment [baseline score]; at access and pulp extirpation, immediately after treatment completion; and 6, 12, 24, and 48 hours after the commencement of treatment). All subjects will be recalled after 2 days to return the pain diary and for a clinical evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- dexamethazone
| Arm | Type | Receives |
|---|---|---|
| Drug dexamethasone | Active comparator | Drug: Dexamethasone Oral Tabletpreoperative single dose of dexamethasone 0.5 mg oral tablet given to patients before starting of root canal treatment by 30 minutes. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be administrated to patients before stating of root canal treatment |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients in good health with no systemic disease (American Society of Anesthesiologists Class II)
- Patients having symptomatic irreversible pulpitis in one of their mandibular molars
- Age range is between 20 and 50 years
- Patients who can understand the categorical tool (points) for measurement
- Patients able to sign informed consent
Key exclusion criteria (8 listed)
- Patients with positive percussion test
- Patients having history of necrosis with or without apical pathosis
- Patients have sinus tract or fistula extraoral or intraoral
- Patients having active pain in more than one molar
- Patients who had taken analgesics in the 12 hours preceding the preparation.
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 |
|---|---|---|
| Dexamethasone Oral Tabletsingle dose of tablet 0.5 mg dexamethasone given to patients before starting of root canal treatment by 30 minutes or placebo | Drug | Drug dexamethasone |
| PlaceboPlacebo will be administrated 30 minutes before start of root canal treatment | Drug | Placebo |
Primary outcome
Postoperative pain
Time frame: 48 hours
Numerical rating scale
1 secondary outcome
success of inferior alveolar nerve block
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
- 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.
Manar Hamouda, Professor study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dexamethasone Oral Tablet in people with Postoperative Pain, run by Cairo University at 1 site in Egypt.
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 5 inclusion and 8 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 27 Jun 2017. 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 Egypt. 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. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact mai M sayed, bachelore (01012232932 ext. 2012, mai.safei247@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: 48 hours). 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 27 Jun 2017.