Postoperative Flare upEarly Phase 1medNCT03209115
Influence of Calcium Hydroxide Chlorhexidine Combination vs. Calcium Hydroxide as an Intra Canal Medicaments in Retreatment Cases
A Early Phase 1 study testing combination of calcium hydroxide and chlorhexidine and Calcium Hydroxide in people with Postoperative Flare up, run by Cairo University.
Trial summary
Influence of Calcium hydroxide Chlorhexidine Combination vs. Calcium Hydroxide as an Intra canal Medicamentson Postoperative flare -up following two-Visit 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 Flare up
- What is being tested?
- combination of calcium hydroxide and chlorhexidine and Calcium Hydroxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 8 Jul 2017to 8 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' 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.
Who cannot join
- Complicating systemic disease
- Having severe pain and/or acute apical abscesses
- Being under 18 years of age
- Using antibiotics or corticosteroids
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Influence of Calcium Hydroxide Chlorhexidine Combination vs. Calcium Hydroxide as an Intra Canal Medicamentson Postoperative Flare -up Following Two-Visit Endodontic Retreatment Cases
Influence of Calcium hydroxide Chlorhexidine Combination vs. Calcium Hydroxide as an Intra canal Medicamentson Postoperative flare -up following two-Visit Endodontic Retreatment cases
Read the detailed description
- Each patient will be anesthetized with the same solution, 40 mg articaine hydrochloride + 0.006 mg/mL epinephrine hydrochloride (Ultracaine DS; Aventis Pharma, Istanbul, Turkey).
- The standard procedure for each group at the first appointment included rubber dam isolation,removing of previous coronal restorations, and root canal filling materials. The removal of previous root canal fillings will be performed with one of these: Gates Glidden drills, hand files, heated pluggers, and Ni-Ti rotary instruments.
- After the removal of previous root canal fillings, the working lengths were determined by apex locator and periapical radiographs 1 mm from the apexes.
- Chemo-mechanical preparation of root canals will be made with the master apical files ranged from #25 to #70 depending on the initial diameter or preparation of the root canals. Irrigation was performed with 2.5% NaOCl after each instrument in all cases. At the end of instrumentation, the final irrigation was made by saline, and the root canals were dried with paper points.
- In the 1st group the root canals will be medicated with a calcium hydroxide paste for 7 days.(calcium hydroxide injectable paste Metapex , 2.2g paste in a 1 syringe). In the 2nd group the root canals will be medicated with a calcium hydroxidechlorhexidine paste for 7 days. The paste consists of 1.2 g Ca(OH)2 powder per 1 mL 0.2% chlorhexidine in water. The teeth in both groups will be closed with a sterile dry cotton pellet and a minimum of 3 mm of temporary restorative material.
- In the next appointment, the tooth was reopened, the intra-canal paste will be removed and a patency file (size 08 Flexofile; Dentsply-Maillefer) was pushed through the foramen.
Master apical file will be checked again and then master cones will be placed and radiographed. Obturation will be done using lateral compaction technique with AD seal resin sealer using spreader for placement of auxiliary cones.
- Conditions
- Postoperative Flare up
- Being tested
- combination of calcium hydroxide and chlorhexidine, Calcium Hydroxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination of calcium hydroxide and chlorhexidineDrug
placement of calcium hydroxide and chlorhexidine as intracanal medicament after removal of old filling and mechanical preparation of root canal
Calcium HydroxideDrug
placement of calcium hydroxide as intracanal medicament after removal of old filling and mechanical preparation of root canal
| Study group | Role | What they receive |
|---|---|---|
| calcium hydroxide and chlorhexidine | Active comparator | Removal of old root canal filling and placing calcium hydroxide and chlorehexidine as intracanal medication Receives: Drug: combination of calcium hydroxide and chlorhexidine |
| calcium hydroxide | Active comparator | Removal of old root canal filling and placing calcium hydroxide as intracanal medication Receives: Drug: Calcium Hydroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative flare up (pain and swelling ) will be measured as below after 7 days from first visit postoperative pain
categorical ( 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start8 Jul 2017 (estimated)
- Primary completion8 Sep 2017 (estimated)
- Study completion8 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 Flare upStudies 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
- Intracanal medication
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hind Midhat AbdulGader Hussein, Cairo University
- Investigators
- Geraldine M Ahmed, Assistant professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209115
- Sponsor's protocol ID
- Hind
- Acronym
- med
- Status last verified
- Jul 2017
- First submitted
- 3 Jul 2017
- Last updated
- 6 Jul 2017
- Results posted
- 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 6 Jul 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 Medicamentson Postoperative Flare -up Following Two-Visit Endodontic Retreatment Cases
- ClinicalTrials.gov ID
- NCT03209115
- Acronym / sponsor ID
- med / Hind
- Conditions
- Postoperative Flare up
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 8 Jul 2017 (estimated)
- Primary completion
- 8 Sep 2017 (estimated)
- Study completion
- 8 Jul 2018 (estimated)
- First posted
- 6 Jul 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.
Influence of Calcium hydroxide Chlorhexidine Combination vs. Calcium Hydroxide as an Intra canal Medicamentson Postoperative flare -up following two-Visit Endodontic Retreatment cases
Detailed description
- Each patient will be anesthetized with the same solution, 40 mg articaine hydrochloride + 0.006 mg/mL epinephrine hydrochloride (Ultracaine DS; Aventis Pharma, Istanbul, Turkey).
- The standard procedure for each group at the first appointment included rubber dam isolation,removing of previous coronal restorations, and root canal filling materials. The removal of previous root canal fillings will be performed with one of these: Gates Glidden drills, hand files, heated pluggers, and Ni-Ti rotary instruments.
- After the removal of previous root canal fillings, the working lengths were determined by apex locator and periapical radiographs 1 mm from the apexes.
- Chemo-mechanical preparation of root canals will be made with the master apical files ranged from #25 to #70 depending on the initial diameter or preparation of the root canals. Irrigation was performed with 2.5% NaOCl after each instrument in all cases. At the end of instrumentation, the final irrigation was made by saline, and the root canals were dried with paper points.
- In the 1st group the root canals will be medicated with a calcium hydroxide paste for 7 days.(calcium hydroxide injectable paste Metapex , 2.2g paste in a 1 syringe). In the 2nd group the root canals will be medicated with a calcium hydroxidechlorhexidine paste for 7 days. The paste consists of 1.2 g Ca(OH)2 powder per 1 mL 0.2% chlorhexidine in water. The teeth in both groups will be closed with a sterile dry cotton pellet and a minimum of 3 mm of temporary restorative material.
- In the next appointment, the tooth was reopened, the intra-canal paste will be removed and a patency file (size 08 Flexofile; Dentsply-Maillefer) was pushed through the foramen.
Master apical file will be checked again and then master cones will be placed and radiographed. Obturation will be done using lateral compaction technique with AD seal resin sealer using spreader for placement of auxiliary cones.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Intracanal medication
| Arm | Type | Receives |
|---|---|---|
| calcium hydroxide and chlorhexidine | Active comparator | Drug: combination of calcium hydroxide and chlorhexidineRemoval of old root canal filling and placing calcium hydroxide and chlorehexidine as intracanal medication |
| calcium hydroxide | Active comparator | Drug: Calcium HydroxideRemoval of old root canal filling and placing calcium hydroxide as intracanal medication |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Complicating systemic disease
- Having severe pain and/or acute apical abscesses
- Being under 18 years of age
- Using antibiotics or corticosteroids
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 |
|---|---|---|
| combination of calcium hydroxide and chlorhexidineplacement of calcium hydroxide and chlorhexidine as intracanal medicament after removal of old filling and mechanical preparation of root canal | Drug | calcium hydroxide and chlorhexidine |
| Calcium Hydroxideplacement of calcium hydroxide as intracanal medicament after removal of old filling and mechanical preparation of root canal | Drug | calcium hydroxide |
Primary outcome
Postoperative flare up (pain and swelling ) will be measured as below after 7 days from first visit postoperative pain
Time frame: 7 days
categorical ( 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 6 Jul 2017.
- Individual participant dataSharing planned: No
Related trials for Postoperative Flare up
Not yet recruiting
Effect of a Herbal Intracanal Medication On Postoperative Pain And Flare up Incidence In Non Surgical Root Canal Retreatment
Postoperative Pain, Flare Up, Symptom
Not yet recruiting
Impact of Integrating Two Nano Based Irrigants With Two Activation Techniques in Treatment of Teeth With Acute Pulpitis on Postoperative Pain and Flare up Incidence
Postoperative Pain, Flare up
Not yet recruiting
Postoperative Pain and Flare-Up Rates in Diabetic Type II Patients Following The Use of Bioceramic Intracanal Medication
Postoperative Pain, Flare Up, Symptom
Not yet recruiting
Comparison of Endodontic Flare up in Single Visit Root Canal Treatment Versus Multiple Visit Root Canal Treatment in Patients Visiting Scd, Swat.
Postoperative Complication, Root Canal Therapy
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.
Geraldine M Ahmed, Assistant professor study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing combination of calcium hydroxide and chlorhexidine and Calcium Hydroxide in people with Postoperative Flare up, 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 5 inclusion and 4 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 6 Jul 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.
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 Hind Midhat Abdul Gader, bachelor (01146912244 ext. 2009, dr.hindhuss7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative flare up (pain and swelling ) will be measured as below after 7 days from first visit postoperative pain (time frame: 7 days). 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 6 Jul 2017.