Postoperative PainNCT07071675
Postoperative Pain and Flare-Up Rates in Diabetic Type II Patients Following The Use of Bioceramic Intracanal Medication
A study testing Calcium Hydroxide Intracanal medication and bioceramic based intracanal medication in people with Postoperative Pain and Flare Up, Symptom, run by Minia University.
Trial summary
The goal of this randomized clinical trial is to evaluate the Postoperative Pain and Flare-Up incidence following the use of Bio-Ceramic Based Intra-Canal Medication in Diabetic type II Patients compared to the Calcium Hydroxide based Intra-canal medicament. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Pain, Flare Up, Symptom, Flare up
- What is being tested?
- Calcium Hydroxide Intracanal medication and bioceramic based intracanal medication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with controlled diabetes mellitus type II.
- Necrotic single rooted teeth:
- with periapical lesion ranging (1-2mm) in diameter.
- with complete root formation.
- Without calcified root canals.
- Without root caries.
- Without external or internal root resorption.
- Without anatomical abnormalities such as fusion.
Who cannot join
- Pregnant females.
- Patients with other systemic diseases in combination with diabetes mellitus.
- Patients under antibiotic or analgesic administration.
- Patients with facial swelling.
- Teeth that are not indicated for endodontic treatment: bad oral hygiene, mobile teeth, or recessed teeth.
- Previously endodontically treated teeth.
- Teeth with sinus tract.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Postoperative Pain and Flare-Up Incidence Following the Use of Bio Ceramic Based Intra-Canal Medication in Diabetic Type II Patients (A Randomized Clinical Trial)
The goal of this randomized clinical trial is to evaluate the Postoperative Pain and Flare-Up incidence following the use of Bio-Ceramic Based Intra-Canal Medication in Diabetic type II Patients compared to the Calcium Hydroxide based Intra-canal medicament.
The main questions it aims to answer are:
Read more
- Is there any difference between using the two intracanal medicaments in the aspects of postoperative pain and flare-up incidence in diabetic type II patients?
- Do intracanal medications reduce postoperative pain and flare-up incidence in diabetic type II patients?
Participants will be divided into two groups:
( both groups will receive root canal treatment in single rooted teeth) then: First group: will receive "Calcium Hydroxide based" intracanal medicament Second group: will receive "Bio-Ceramic Based" intracanal medicament
Postoperative pain will be assessed using:
- visual analog scale (VAS), A scale from (0 to 10) where "0" means no pain and "10" means a severe pain that has never faced before.
- Patients will be contacted by phone at 6, 12, 24, 48, 72 hours and 7 days after the first visit to collect the postoperative pain data.
Flare-up is assessed:
- by asking the patient to notify the investigator if any sudden severe pain or swelling takes place.
- Conditions
- Postoperative Pain, Flare Up, Symptom, Flare up, Diabete Type 2
- Being tested
- Calcium Hydroxide Intracanal medication, bioceramic based intracanal medication
- Keywords
- postoperative pain, flare up, diabetes type II, Intra-Canal medication, bioceramic, calcium hydroxide
- Medical subject headings
- Pain, Postoperative, Symptom Flare Up, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium Hydroxide Intracanal medicationDrug
Treated using calcium hydroxide based material as an intracanal medicament
bioceramic based intracanal medicationDrug
treated using bio-ceramic based material as an intracanal medicament
| Study group | Role | What they receive |
|---|---|---|
| Calcium Hydroxide Group (GROUP I) | Experimental | Treated using calcium hydroxide as an intracanal medicament (n=28) Receives: Drug: Calcium Hydroxide Intracanal medication |
| Bioceramic Group (GROUP II) | Experimental | treated using bio-ceramic based material as an intracanal medicament (n=28) Receives: Drug: bioceramic based intracanal medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain intensity
Postoperative pain is to be assessed using visual analog scale (VAS), A scale from (0 to 10) where "0" means no pain and "10" means a severe pain that has never faced before.
Patients will be contacted by phone at 6, 12, 24, 48, 72 hours and 7 days after the first visit to collect the postoperative pain data.
Measured: 6, 12, 24, 48, 72 hours and 7 days after the first visit to collect the postoperative pain data.
Flare-Up Incidence
Flare-up is assessed through asking the patient to notify the investigator if any sudden severe pain or swelling takes place.
This could require an unscheduled emergency visit or prescription of additional medication.
Measured: Within 7 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completionSep 2026 (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 Minia 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
- Model description
- Participants will be randomly assigned to one of two parallel groups. Each group will receive a different intracanal medicament following root canal treatment. Postoperative pain and flare-up incidence will be assessed and compared between the two groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulrahman Issam Abdulkareem Marie, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071675
- Sponsor's protocol ID
- MU-EC Research NO.1064
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be shared due to privacy concerns and the limited scope of data use approved by the ethics committee. The study is designed for internal analysis only and does not include provisions for public data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain and Flare-Up Incidence Following the Use of Bio Ceramic Based Intra-Canal Medication in Diabetic Type II Patients (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT07071675
- Acronym / sponsor ID
- MU-EC Research NO.1064
- Conditions
- Postoperative Pain, Flare Up, Symptom, Flare up, Diabete Type 2
- Keywords
- postoperative pain, flare up, diabetes type II, Intra-Canal medication, bioceramic, calcium hydroxide
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 17 Jul 2025 (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 goal of this randomized clinical trial is to evaluate the Postoperative Pain and Flare-Up incidence following the use of Bio-Ceramic Based Intra-Canal Medication in Diabetic type II Patients compared to the Calcium Hydroxide based Intra-canal medicament.
The main questions it aims to answer are:
- Is there any difference between using the two intracanal medicaments in the aspects of postoperative pain and flare-up incidence in diabetic type II patients?
- Do intracanal medications reduce postoperative pain and flare-up incidence in diabetic type II patients?
Participants will be divided into two groups:
( both groups will receive root canal treatment in single rooted teeth) then: First group: will receive "Calcium Hydroxide based" intracanal medicament Second group: will receive "Bio-Ceramic Based" intracanal medicament
Postoperative pain will be assessed using:
- visual analog scale (VAS), A scale from (0 to 10) where "0" means no pain and "10" means a severe pain that has never faced before.
- Patients will be contacted by phone at 6, 12, 24, 48, 72 hours and 7 days after the first visit to collect the postoperative pain data.
Flare-up is assessed:
- by asking the patient to notify the investigator if any sudden severe pain or swelling takes place.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups. Each group will receive a different intracanal medicament following root canal treatment. Postoperative pain and flare-up incidence will be assessed and compared between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Calcium Hydroxide Group (GROUP I) | Experimental | Drug: Calcium Hydroxide Intracanal medicationTreated using calcium hydroxide as an intracanal medicament (n=28) |
| Bioceramic Group (GROUP II) | Experimental | Drug: bioceramic based intracanal medicationtreated using bio-ceramic based material as an intracanal medicament (n=28) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with controlled diabetes mellitus type II.
- Necrotic single rooted teeth:
Key exclusion criteria (7 listed)
- Pregnant females.
- Patients with other systemic diseases in combination with diabetes mellitus.
- Patients under antibiotic or analgesic administration.
- Patients with facial swelling.
- Teeth that are not indicated for endodontic treatment: bad oral hygiene, mobile teeth, or recessed teeth.
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 Intracanal medicationTreated using calcium hydroxide based material as an intracanal medicament | Drug | Calcium Hydroxide Group (GROUP I) |
| bioceramic based intracanal medicationtreated using bio-ceramic based material as an intracanal medicament | Drug | Bioceramic Group (GROUP II) |
Primary outcome
postoperative pain intensity
Time frame: 6, 12, 24, 48, 72 hours and 7 days after the first visit to collect the postoperative pain data.
Postoperative pain is to be assessed using visual analog scale (VAS), A scale from (0 to 10) where "0" means no pain and "10" means a severe pain that has never faced before. Patients will be contacted by phone at 6, 12, 24, 48, 72 hours and 7 days after the first visit to collect the postoperative pain data.
Flare-Up Incidence
Time frame: Within 7 days post-treatment
Flare-up is assessed through asking the patient to notify the investigator if any sudden severe pain or swelling takes place. This could require an unscheduled emergency visit or prescription of additional medication.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be shared due to privacy concerns and the limited scope of data use approved by the ethics committee. The study is designed for internal analysis only and does not include provisions for public data sharing.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium Hydroxide Intracanal medication and bioceramic based intracanal medication in people with Postoperative Pain and Flare Up, Symptom, run by Minia 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 7 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: opening soon, as of the sponsor's last update on 20 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdulrahman Issam Marie (+201069060274, mr.marie98@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain intensity (time frame: 6, 12, 24, 48, 72 hours and 7 days after the first visit to collect the postoperative pain data.). 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 20 Jul 2025.