Endodontic DiseasePhase 2NCT06913673
Postoperative Pain and Incidence of Extrusion Following the Use of Two Intra-canal Medications in Retreatment of Single Rooted Teeth
A Phase 2 study testing Bio-c Temp and Metapex in people with Endodontic Disease, run by Minia University.
Trial summary
This study aims to compare the postoperative pain and incidence of extrusion of two intracanal medications in the retreatment of single-rooted teeth. The main question it aims to answer is: Does the injection of intra-canal medication into the shaped root canal after complete removal of the old obturating material… Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Endodontic Disease
- What is being tested?
- Bio-c Temp and Metapex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 1 May 2025
- Phase
- Phase 2
- 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 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with failed endodontic treatment in single root teeth
- Systemic free
Who cannot join
- Muktirooted teeth
About this study
This study aims to compare the postoperative pain and incidence of extrusion of two intracanal medications in the retreatment of single-rooted teeth.
The main question it aims to answer is:
Does the injection of intra-canal medication into the shaped root canal after complete removal of the old obturating material lead to post-operative pain and paste extrusion to periapical tissues or not?
- Conditions
- Endodontic Disease
- Being tested
- Bio-c Temp, Metapex
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio-c TempOther
Intra-canal medication
MetapexOther
Intra-canal medication
| Study group | Role | What they receive |
|---|---|---|
| Group A: Metapex | Experimental | Non- surgical root canal retreatment with application of Metapex in to root canal after complete removal of the old obturation material. Receives: Other: Metapex |
| Group A:Bio-c Temp | Experimental | Non- surgical root canal retreatment with application of Bio-c Temp paste in to root canal after complete removal of the old obturation material. Receives: Other: Bio-c Temp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical assessment of the post retreatment pain.
Pain scores will be recorded on visual analog scale (VAS) using a 0 to 10 pain score basis with 0 being no pain and 10 being the worst pain the patient had ever experienced. (Record will be every 24h for 7 days)
Measured: One week after re-treatment procdure
Radiographic assessment of the extrusion of the paste into periapical tissues using Digital radiograph
Extrusion of the paste into periapical incidence of extrusion: Conventional digital radiograph will be taken after using intracanal medication pastes.
Measured: Immediate after retreatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontic DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ali, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913673
- Sponsor's protocol ID
- 1026/114
- Status last verified
- Apr 2025
- First submitted
- 20 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain and Incidence of Extrusion Following the Use of Two Intra-canal Medications in Retreatment of Single Rooted Teeth
- ClinicalTrials.gov ID
- NCT06913673
- Acronym / sponsor ID
- 1026/114
- Conditions
- Endodontic Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 6 Apr 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.
This study aims to compare the postoperative pain and incidence of extrusion of two intracanal medications in the retreatment of single-rooted teeth.
The main question it aims to answer is:
Does the injection of intra-canal medication into the shaped root canal after complete removal of the old obturating material lead to post-operative pain and paste extrusion to periapical tissues or not?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Metapex | Experimental | Other: MetapexNon- surgical root canal retreatment with application of Metapex in to root canal after complete removal of the old obturation material. |
| Group A:Bio-c Temp | Experimental | Other: Bio-c TempNon- surgical root canal retreatment with application of Bio-c Temp paste in to root canal after complete removal of the old obturation material. |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients with failed endodontic treatment in single root teeth
- Systemic free
Key exclusion criteria (1 listed)
- Muktirooted 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 |
|---|---|---|
| Bio-c TempIntra-canal medication | Other | Group A:Bio-c Temp |
| MetapexIntra-canal medication | Other | Group A: Metapex |
Primary outcome
Clinical assessment of the post retreatment pain.
Time frame: One week after re-treatment procdure
Pain scores will be recorded on visual analog scale (VAS) using a 0 to 10 pain score basis with 0 being no pain and 10 being the worst pain the patient had ever experienced. (Record will be every 24h for 7 days)
Radiographic assessment of the extrusion of the paste into periapical tissues using Digital radiograph
Time frame: Immediate after retreatment
Extrusion of the paste into periapical incidence of extrusion: Conventional digital radiograph will be taken after using intracanal medication pastes.
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 6 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bio-c Temp and Metapex in people with Endodontic Disease, 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 2 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: opening soon, as of the sponsor's last update on 6 Apr 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Clinical assessment of the post retreatment pain. (time frame: One week after re-treatment procdure). 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 6 Apr 2025.