Symptomatic Apical Periodontitis(BCvsCaOH)NCT07585721
Postoperative Pain and Substance P Levels After Bioceramic vs Calcium Hydroxide Intracanal Medicaments in Symptomatic Apical Periodontitis
A study testing Calcium Hydroxide (Ca(OH)2) and Bioceramic Intracanal Medicament in people with Symptomatic Apical Periodontitis, run by Future University in Egypt at 1 site in Egypt.
Trial summary
Clinical Evaluation of the Postoperative Pain and Substance P levels Following the use of Bioceramic verses Calcium Hydroxide Intracanal Medicaments in Permanent Mandibular molars with Symptomatic Apical Periodontitis Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Symptomatic Apical Periodontitis
- What is being tested?
- Calcium Hydroxide (Ca(OH)2) and Bioceramic Intracanal Medicament
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2026to 1 Feb 2027
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- - Patients aged 18-45 years with no sex predilection
- Medically free Patients with no systemic conditions that can affect post operative pain response.
- Patients should not be taking any pain medications 24 hours before intervention
- Positive patients' acceptance for participating in the study
- Patient able to sign informed consent
- Permanent mandibular molars diagnosis with Symptomatic Apical Periodontitis
- Permanent molars without any anatomical variations or severe curvatures
Who cannot join
- - Medically compromised patients
- Patients who have received antibiotic therapy within the last 2 weeks.
- Pregnant or lactating women.
- Patients with known allergy to any of the irrigants used.
- Patients with swelling or acute peri-apical abscess or fistulous tract.
- Teeth that have:
Show all 14Show fewer
- Wide or open apex .
- Vital pulp tissue .
- Periodontally affected with grade 2or 3 mobility.
- Non restorable teeth .
- Abnormal anatomy and calcified canals .
- Pervious root canal treatment.
- severe curved canal
- Buccolingual and mesiodistal radiographs were taken to evaluate the root canal anatomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Salma Tarek Abdullah, Bachelors degree contact
Egypt1 site, 1 recruiting
- Recruiting
Future University in Egypt - Faculty of Oral and Dental Medicine
Cairo
About this study
Official title: Clinical Evaluation of the Postoperative Pain and Substance P Levels Following the Use of Bioceramic Verses Calcium Hydroxide Intracanal Medicaments in Permanent Mandibular Molars With Symptomatic Apical Periodontitis
Clinical Evaluation of the Postoperative Pain and Substance P levels Following the use of Bioceramic verses Calcium Hydroxide Intracanal Medicaments in Permanent Mandibular molars with Symptomatic Apical Periodontitis
Read the detailed description
This study aims to evaluate postoperative pain levels and Substance P expression following the use of two different intracanal medicaments: bioceramic materials and calcium hydroxide in permanent mandibular molars diagnosed with symptomatic apical periodontitis.
A total of 28 patients will be included in this study and randomly allocated into two equal groups (n=14 each). Group I will receive calcium hydroxide (Ca(OH)₂) as an intracanal medicament, while Group II will receive a bioceramic intracanal medicament.
Standardized endodontic procedures will be performed for all participants. Postoperative pain will be assessed using a visual analog scale (VAS) at different time intervals following treatment.
In addition, samples will be collected to evaluate Substance P levels as a biochemical marker associated with pain and inflammation.
The comparison between the two groups will help determine the effectiveness of each intracanal medicament in reducing postoperative pain and inflammatory response. The results of this study may contribute to improving clinical decision-making in endodontic therapy.
- Conditions
- Symptomatic Apical Periodontitis
- Being tested
- Calcium Hydroxide (Ca(OH)2), Bioceramic Intracanal Medicament
- Keywords
- Postoperative Pain, Substance P, Calcium Hydroxide, Bioceramic intra-canal medication, BIO-C TEMP, Mandibular Molars, Intra canal medication, Endodontics, Root Canal Treatment, inflammatory mediators, Symptomatic Apical Periodontitis
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium Hydroxide (Ca(OH)2)Drug
Also called Meta paste - Meta Biomed
Calcium hydroxide will be used as an intracanal medicament during root canal treatment in Permanent Mandibular molars with Symptomatic Apical Periodontitis
Bioceramic Intracanal MedicamentDrug
Also called Bio- C temp - Angelus
Bioceramic material will be used as an intracanal medicament during root canal treatment in Permanent Mandibular molars with Symptomatic Apical Periodontitis
| Study group | Role | What they receive |
|---|---|---|
| Calcium Hydroxide Group | Experimental | Meta Paste (Meta Biomed) Receives: Drug: Calcium Hydroxide (Ca(OH)2) |
| Bioceramic Group | Experimental | Bio-C Temp Angelus Receives: Drug: Bioceramic Intracanal Medicament |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of postoperative pain levels
Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores will be recorded at 6 hours, 24 hours, 48 hours, 72 hours, and 7 days after treatment to compare postoperative pain levels between the two medicament groups and evaluate the correlation between Substance P reduction and pain perception.
Measured: one week
Secondary outcomes (1)
neurogenic biomarker Substance P Level
To compare the effectiveness of bio ceramic intracanal medicament (Bio-C Temp) and calcium hydroxide in reducing the neurogenic biomarker Substance P in periapical samples of molars diagnosed with symptomatic apical periodontitis
Measured: one week after the pulp Extirpation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start1 Jun 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Apical PeriodontitisStudies 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
- Model description
- Participants will be randomly assigned into two parallel groups to receive either calcium hydroxide or bioceramic intracanal medicament.
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, salma tarek abdullah, Future University in Egypt
- Investigators
- Adel Abdelwahed, Prof. Ass. of endodontic, Principal investigator, Prof. Ass. of endodontic, faculty of Oral and Dental Medicine Future University in EgyptAhmed Amer ibrahim elwakad, Lecturer of Endodontics, Principal investigator, Lecturer of Endodontics, Faculty of Oral and Dental Medicine, Future university in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585721
- Sponsor's protocol ID
- FUE.REC(24)/2-2026
- Acronym
- (BCvsCaOH)
- Status last verified
- Jun 2026
- First submitted
- 27 Apr 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Postoperative Pain and Substance P Levels Following the Use of Bioceramic Verses Calcium Hydroxide Intracanal Medicaments in Permanent Mandibular Molars With Symptomatic Apical Periodontitis
- ClinicalTrials.gov ID
- NCT07585721
- Acronym / sponsor ID
- (BCvsCaOH) / FUE.REC(24)/2-2026
- Conditions
- Symptomatic Apical Periodontitis
- Keywords
- Postoperative Pain, Substance P, Calcium Hydroxide, Bioceramic intra-canal medication, BIO-C TEMP, Mandibular Molars, Intra canal medication, Endodontics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 14 May 2026 (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.
Clinical Evaluation of the Postoperative Pain and Substance P levels Following the use of Bioceramic verses Calcium Hydroxide Intracanal Medicaments in Permanent Mandibular molars with Symptomatic Apical Periodontitis
Detailed description
This study aims to evaluate postoperative pain levels and Substance P expression following the use of two different intracanal medicaments: bioceramic materials and calcium hydroxide in permanent mandibular molars diagnosed with symptomatic apical periodontitis.
A total of 28 patients will be included in this study and randomly allocated into two equal groups (n=14 each). Group I will receive calcium hydroxide (Ca(OH)₂) as an intracanal medicament, while Group II will receive a bioceramic intracanal medicament.
Standardized endodontic procedures will be performed for all participants. Postoperative pain will be assessed using a visual analog scale (VAS) at different time intervals following treatment.
In addition, samples will be collected to evaluate Substance P levels as a biochemical marker associated with pain and inflammation.
The comparison between the two groups will help determine the effectiveness of each intracanal medicament in reducing postoperative pain and inflammatory response. The results of this study may contribute to improving clinical decision-making in endodontic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned into two parallel groups to receive either calcium hydroxide or bioceramic intracanal medicament.
| Arm | Type | Receives |
|---|---|---|
| Calcium Hydroxide Group | Experimental | Drug: Calcium Hydroxide (Ca(OH)2)Meta Paste (Meta Biomed) |
| Bioceramic Group | Experimental | Drug: Bioceramic Intracanal MedicamentBio-C Temp Angelus |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- - Patients aged 18-45 years with no sex predilection
- Medically free Patients with no systemic conditions that can affect post operative pain response.
- Patients should not be taking any pain medications 24 hours before intervention
- Positive patients' acceptance for participating in the study
- Patient able to sign informed consent
Key exclusion criteria (14 listed)
- - Medically compromised patients
- Patients who have received antibiotic therapy within the last 2 weeks.
- Pregnant or lactating women.
- Patients with known allergy to any of the irrigants used.
- Patients with swelling or acute peri-apical abscess or fistulous tract.
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 (Ca(OH)2)Also: Meta paste - Meta BiomedCalcium hydroxide will be used as an intracanal medicament during root canal treatment in Permanent Mandibular molars with Symptomatic Apical Periodontitis | Drug | Calcium Hydroxide Group |
| Bioceramic Intracanal MedicamentAlso: Bio- C temp - AngelusBioceramic material will be used as an intracanal medicament during root canal treatment in Permanent Mandibular molars with Symptomatic Apical Periodontitis | Drug | Bioceramic Group |
Primary outcome
Assessment of postoperative pain levels
Time frame: one week
Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores will be recorded at 6 hours, 24 hours, 48 hours, 72 hours, and 7 days after treatment to compare postoperative pain levels between the two medicament groups and evaluate the correlation between Substance P reduction and pain perception.
1 secondary outcome
neurogenic biomarker Substance P Level
Time frame: one week after the pulp Extirpation
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 25 Sep 2026.
- Individual participant dataSharing planned: No. No individual participant data will be shared.
Related trials for Symptomatic Apical Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruiting
Multiple-Visit RCT in Teeth With SAP: Interappointment Dressing or Not?
Endodontically Treated Teeth, Calcium Hydroxide
Recruiting
Effect of Ultrasonic and Diode Laser Activated Irrigation on Postoperative Pain Following Root Canal Treatment
Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis
Not yet recruiting
Photobiomodulation After Nonsurgical Root Canal Treatment
Symptomatic Apical Periodontitis, Postoperative Pain
Not yet recruiting
Comparison of Postoperative Pain After Root Canal Treatment Using Hand-Held vs Rotary ProTaper Files: A Randomized Controlled Trial
Symptomatic Irreversible Pulpitis (SIP), Symptomatic Apical Periodontitis
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.
Salma Tarek Abdullah, Bachelors degree contact
Adel Abdelwahed, Prof. Ass. of endodontic principal investigator
Prof. Ass. of endodontic, faculty of Oral and Dental Medicine Future University in Egypt
Ahmed Amer ibrahim elwakad, Lecturer of Endodontics principal investigator
Lecturer of Endodontics, Faculty of Oral and Dental Medicine, Future university in Egypt
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 (Ca(OH)2) and Bioceramic Intracanal Medicament in people with Symptomatic Apical Periodontitis, run by Future University in Egypt 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 7 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 25 Sep 2026. 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?
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 Salma Tarek Abdullah, Bachelors degree (+201060044225 ext. +201007510555, salma1319142066@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of postoperative pain levels (time frame: 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 25 Sep 2026.