Postoperative PainNCT03064191
Influence of Intra Canal Medications on Postoperative Flare-up in Endodontic Re-treatment Cases
A study testing calcium hydroxide chlorhexidine combination and calcium hydroxide intra-canal medicament in people with Postoperative Pain and Pain, Dental, run by rayan rabie dahab at 1 site in Egypt.
Trial summary
Is to evaluate the influence of the calcium hydroxide / chlorhexidine combination and calcium hydroxide alone as an intra-canal medication in postoperative flare-up in two visits endodontic retreatment cases 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, Pain, Dental
- What is being tested?
- calcium hydroxide chlorhexidine combination and calcium hydroxide intra-canal medicament
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2017to 13 Apr 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
- 1. Patients' needs retreatment.
- 2. Patients in good health with no systemic disease (American Society of Anesthesiologists Class II)
- 3. Age range is between 20 and 50 years.
- 4. Patients who can understand the categorical tool (points)for measurement
- 5. Patients able to sign informed consent.
Who cannot join
- 1) Complicating systemic disease
- 2) Having severe pain and/or acute apical abscesses
- 3) Being under 18 years of age
- 4) Using antibiotics or corticosteroids,
- 5) having multiple teeth that required retreatment to eliminate the possibility of pain referral
- 6) Having root canals that could not be treated well with initial root canal treatment.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Univeristy of Cairo
Cairo
rayan ra dahab, master, 00201068775688, rayanrabiedahab@gmail.com
hisham na hassan, master, 00201068778033, dr_hishamnabeel@hotmail.com
About this study
Official title: Influence of Calcium Hydroxide Chlorhexidine Combination vs. Calcium Hydroxide as an Intra Canal Medicaments on Postoperative Flare -up Following Two-Visits Endodontic Retreatment Cases: Single Blinded Randomized Clinical Trial
Is to evaluate the influence of the calcium hydroxide / chlorhexidine combination and calcium hydroxide alone as an intra-canal medication in postoperative flare-up in two visits endodontic retreatment cases
Read the detailed description
Problem: patient needs retreatment Intervention: calcium hydroxide chlorhexidine combination as an intra-canal medicament Control: calcium hydroxide alone as an intra-canal medicament Outcome: postoperative flare-up (pain and swelling) Time: after 7 days from 1st visit. population will be examined:
- Patients' needs retreatment.
- Patients in good health with no systemic disease (American Society of Anesthesiologists Class II)
- Age range is between 20 and 50 years.
- Patients who can understand the categorical tool (points)for measurement
- Patients able to sign informed consent.
- Conditions
- Postoperative Pain, Pain, Dental
- Being tested
- calcium hydroxide chlorhexidine combination, calcium hydroxide intra-canal medicament
- Keywords
- intra-canal medications
- Medical subject headings
- Pain, Postoperative, Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcium hydroxide chlorhexidine combinationCombination product
Also called intra-canal medicament combination
Endodontic intra-canal medicament used for decreasing postoperative signs ans symptoms
calcium hydroxide intra-canal medicamentOther
Also called calcium hydroxide, gold standard intra-canal medicament
Endodontic intra-canal medicament used for decreasing postoperative signs and symptoms.
| Study group | Role | What they receive |
|---|---|---|
| calcium hydroxide chlorhexidine | Active comparator | intervention: calcium hydroxide chlorhexidine combination an intra-canal medication composed of calcium hydroxide powder and chlorhexidine solution as a combination to be administered as intra-canal paste for decreasing postoperative symptoms Receives: Combination Product: calcium hydroxide chlorhexidine combination |
| calcium hydroxide | Active comparator | intervention: calcium hydroxide an intra-canal medicament composed of calcium hydroxide paste for decreasing postoperative symptoms and signs . Receives: Other: calcium hydroxide intra-canal medicament |
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring patients postoperative pain and swelling following endodontic re-treatment sessions using Categorical (4 points) unit using questionnaire.
postoperative pain and swelling will be measured by:Categorical (4 points). The incidence of postoperative discomfort was recorded and expressed as numbers and percentages
Subjectively into 4 points:
- no pain
- Mild pain: recognizable but not discomforting pain that required no analgesics.
- Moderate pain: discomforting but bearable pain(analgesics if used were effective in relieving pain)
- Severe pain: difficult to bear (analgesics were effective in relieving pain). Patients with severe postoperative pain and/or occurrence of swelling were classified as flare-ups.3 Objectively : percussion test
Measured: 7 days between the 2 visits ( one week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study startSep 2017 (estimated)
- Primary completion13 Mar 2018 (estimated)
- Study completion13 Apr 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.
- 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
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- rayan rabie dahab
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, rayan rabie dahab, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064191
- Sponsor's protocol ID
- CEBD-CU-2017-02-11
- Status last verified
- Sep 2017
- First submitted
- 16 Feb 2017
- Last updated
- 12 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Calcium Hydroxide Chlorhexidine Combination vs. Calcium Hydroxide as an Intra Canal Medicaments on Postoperative Flare -up Following Two-Visits Endodontic Retreatment Cases: Single Blinded Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03064191
- Acronym / sponsor ID
- CEBD-CU-2017-02-11
- Conditions
- Postoperative Pain, Pain, Dental
- Keywords
- intra-canal medications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- rayan rabie dahabUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- Sep 2017 (estimated)
- Primary completion
- 13 Mar 2018 (estimated)
- Study completion
- 13 Apr 2018 (estimated)
- First posted
- 24 Feb 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.
Is to evaluate the influence of the calcium hydroxide / chlorhexidine combination and calcium hydroxide alone as an intra-canal medication in postoperative flare-up in two visits endodontic retreatment cases
Detailed description
Problem: patient needs retreatment Intervention: calcium hydroxide chlorhexidine combination as an intra-canal medicament Control: calcium hydroxide alone as an intra-canal medicament Outcome: postoperative flare-up (pain and swelling) Time: after 7 days from 1st visit. population will be examined:
- Patients' needs retreatment.
- Patients in good health with no systemic disease (American Society of Anesthesiologists Class II)
- Age range is between 20 and 50 years.
- Patients who can understand the categorical tool (points)for measurement
- Patients able to sign informed consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| calcium hydroxide chlorhexidine | Active comparator | Combination Product: calcium hydroxide chlorhexidine combinationintervention: calcium hydroxide chlorhexidine combination an intra-canal medication composed of calcium hydroxide powder and chlorhexidine solution as a combination to be administered as intra-canal paste for decreasing postoperative symptoms |
| calcium hydroxide | Active comparator | Other: calcium hydroxide intra-canal medicamentintervention: calcium hydroxide an intra-canal medicament composed of calcium hydroxide paste for decreasing postoperative symptoms and signs . |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 1. Patients' needs retreatment.
- 2. Patients in good health with no systemic disease (American Society of Anesthesiologists Class II)
- 3. Age range is between 20 and 50 years.
- 4. Patients who can understand the categorical tool (points)for measurement
- 5. Patients able to sign informed consent.
Key exclusion criteria (6 listed)
- 1) Complicating systemic disease
- 2) Having severe pain and/or acute apical abscesses
- 3) Being under 18 years of age
- 4) Using antibiotics or corticosteroids,
- 5) having multiple teeth that required retreatment to eliminate the possibility of pain referral
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 |
|---|---|---|
| calcium hydroxide chlorhexidine combinationAlso: intra-canal medicament combinationEndodontic intra-canal medicament used for decreasing postoperative signs ans symptoms | Combination product | calcium hydroxide chlorhexidine |
| calcium hydroxide intra-canal medicamentAlso: calcium hydroxide, gold standard intra-canal medicamentEndodontic intra-canal medicament used for decreasing postoperative signs and symptoms. | Other | calcium hydroxide |
Primary outcome
measuring patients postoperative pain and swelling following endodontic re-treatment sessions using Categorical (4 points) unit using questionnaire.
Time frame: 7 days between the 2 visits ( one week)
postoperative pain and swelling will be measured by:Categorical (4 points). The incidence of postoperative discomfort was recorded and expressed as numbers and percentages Subjectively into 4 points: 1. no pain 2. Mild pain: recognizable but not discomforting pain that required no analgesics. 3. Moderate pain: discomforting but bearable pain(analgesics if used were effective in relieving pain) 4. Severe pain: difficult to bear (analgesics were effective in relieving pain). Patients with severe postoperative pain and/or occurrence of swelling were classified as flare-ups.3 Objectively : percussion test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing calcium hydroxide chlorhexidine combination and calcium hydroxide intra-canal medicament in people with Postoperative Pain and Pain, Dental, run by rayan rabie dahab 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 6 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 12 Sep 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. 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?
Contact associate professor (00201226322227, Geraldine.ahmed@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measuring patients postoperative pain and swelling following endodontic re-treatment sessions using Categorical (4 points) unit using questionnaire. (time frame: 7 days between the 2 visits ( one week)). 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 12 Sep 2017.