Patients Diagnosed With Persistent Apical Periodontitis in Maxillary Anterior Regions Require Endodontic MicrosurgeryNCT07879482
Bone-Bioactive Liquid as an Adjunct in Endodontic Surgery
A study testing Bone Bioactive Liquid in endosurgery and conventional endodontic surgery in people with Patients Diagnosed With Persistent Apical Periodontitis in Maxillary Anterior Regions Require Endodontic Microsurgery, run by Ain Shams University.
Trial summary
This randomized controlled clinical trial will include patients indicated for endodontic microsurgery due to persistent periapical lesions. Participants will be randomly allocated into two groups. Preoperative CBCT will be taken for each patient, and patients will be scheduled for endodontic microsurgery. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Patients Diagnosed With Persistent Apical Periodontitis in Maxillary Anterior Regions Require Endodontic Microsurgery
- What is being tested?
- Bone Bioactive Liquid in endosurgery and conventional endodontic surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to Dec 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Inclusion Criteria: Patients diagnosed with persistent apical periodontitis in maxillary anterior regions require endodontic microsurgery
- Lesion diameter 5-8mm Exclusion Criteria: smokers
- Diabetic patients
- pregnancy
- root fracture
- Teeth require adjunctive procedures at the time of root-end surgery, such as root amputation, soft tissue grafting, replantation, or perforation repair.
- previous apical surgery
- immunocompromised patients.
About this study
Official title: Bone-Bioactive Liquid as an Adjunct in Endodontic Surgery: Effects on Postoperative Healing and Inflammatory Mediator Expression. (Randomized Controlled Clinical Trial)
This randomized controlled clinical trial will include patients indicated for endodontic microsurgery due to persistent periapical lesions. Participants will be randomly allocated into two groups. Preoperative CBCT will be taken for each patient, and patients will be scheduled for endodontic microsurgery. Preoperative gingival crevicular fluid samples will be collected. During the surgical procedure the test group will receive application of BBL as a final flush to the bony cavity and surface conditioning of the root end before closure of the surgical site, while the control group will undergo conventional microsurgery without BBL. Standardized surgical procedures will be followed in both groups. Postoperative pain will be assessed using the Visual Analog Scale (VAS) at defined time points following surgery. Inflammatory mediator expressions (e.g., IL-1β and TNF α) will be evaluated using enzyme-linked immunosorbent assay (ELISA) in comparison to preoperative samples to assess the inflammatory response associated with healing at 10th day postsurgical followed by soft tissue healing clinical assessment using Early Healing Score (EHS). Bone healing will be assessed radiographically using cone-beam computed tomography (CBCT) at 6-month follow-ups, with quantitative three-dimensional analysis of lesion volume reduction
- Being tested
- Bone Bioactive Liquid in endosurgery, conventional endodontic surgery
- Keywords
- Bone Bioactive liquid , endosurgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Bioactive Liquid in endosurgeryOther
A volume of bone bioactive liquid (BBL) (Theravex Tissue Care Plus) will be used depending on the size of lesion calculated using standard equation (π/6×D×W×H) and based upon what was suggested in implant surgery . The solution will be delivered to the bony crypt and root-end surface using a sterile syringe with a blunt needle to ensure complete coverage of the exposed bone walls and resected root surface. The BBL will remain in passive contact with the surgical site for 60-secs seconds without suction to facilitate adsorption and interaction with the mineralized tissues. Excess solutions will gently be aspirated without additional irrigation to preserve the bioactive layer. The flap will be repositioned and sutured using microsurgical techniques.
conventional endodontic surgeryProcedure or surgery
conventional endodontic microsurgery will be performed
| Study group | Role | What they receive |
|---|---|---|
| BBL group | Experimental | A volume of bone bioactive liquid (BBL) (Theravex Tissue Care Plus) will be used depending on the size of lesion calculated using standard equation (π/6×D×W×H) and based upon what was suggested in implant surgery . The solution will be delivered to the bony crypt and root-end surface using a sterile syringe with a blunt needle to ensure complete coverage of the exposed bone walls and resected root surface.
The BBL will remain in passive contact with the surgical site for 60-secs seconds without suction to facilitate adsorption and interaction with the mineralized tissues.
Excess solutions will gently be aspirated without additional irrigation to preserve the bioactive layer. The flap will be repositioned and sutured using microsurgical techniques. Receives: Other: Bone Bioactive Liquid in endosurgery |
| Control group | Active comparator | conventional endodontic microsurgery will be performed Receives: Procedure: conventional endodontic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periapical bone healing assessed radiographically using CBCT
Preoperative CBCT will be taken. CBCT scans will be obtained.Another scan will be taken after 6 months with cumulative exposure pre and post approximately 240 µSv (0.24 mSv), which is comparable to nearly 24 days of natural background radiation exposure.
Measured: 1 year
Secondary outcomes (1)
Expression levels of inflammatory mediator
Gingival crevicular fluid (GCF) samples will be collected from the surgical site using standardized paper strips (PerioPaper). Prior to sampling, the area will be isolated with cotton rolls and gently air-dried to prevent saliva contamination. Paper strips will be inserted 1-2 mm into the gingival sulcus adjacent to the surgical site and will be left in place for 30 seconds. Samples contaminated with blood or saliva will be discarded.
Collected samples will be stored immediately at -80°C until analysis.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Diagnosed With Persistent Apical Periodontitis in Maxillary Anterior Regions Require Endodontic MicrosurgeryStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia Hani, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879482
- Sponsor's protocol ID
- Ain Shams University
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone-Bioactive Liquid as an Adjunct in Endodontic Surgery: Effects on Postoperative Healing and Inflammatory Mediator Expression. (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07879482
- Acronym / sponsor ID
- Ain Shams University
- Keywords
- Bone Bioactive liquid , endosurgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 16 Oct 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.
This randomized controlled clinical trial will include patients indicated for endodontic microsurgery due to persistent periapical lesions. Participants will be randomly allocated into two groups. Preoperative CBCT will be taken for each patient, and patients will be scheduled for endodontic microsurgery. Preoperative gingival crevicular fluid samples will be collected. During the surgical procedure the test group will receive application of BBL as a final flush to the bony cavity and surface conditioning of the root end before closure of the surgical site, while the control group will undergo conventional microsurgery without BBL. Standardized surgical procedures will be followed in both groups. Postoperative pain will be assessed using the Visual Analog Scale (VAS) at defined time points following surgery. Inflammatory mediator expressions (e.g., IL-1β and TNF α) will be evaluated using enzyme-linked immunosorbent assay (ELISA) in comparison to preoperative samples to assess the inflammatory response associated with healing at 10th day postsurgical followed by soft tissue healing clinical assessment using Early Healing Score (EHS). Bone healing will be assessed radiographically using cone-beam computed tomography (CBCT) at 6-month follow-ups, with quantitative three-dimensional analysis of lesion volume reduction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BBL group | Experimental | Other: Bone Bioactive Liquid in endosurgeryA volume of bone bioactive liquid (BBL) (Theravex Tissue Care Plus) will be used depending on the size of lesion calculated using standard equation (π/6×D×W×H) and based upon what was suggested in implant surgery . The solution will be delivered to the bony crypt and root-end surface using a sterile syringe with a blunt needle to ensure complete coverage of the exposed bone walls and resected root surface. The BBL will remain in passive contact with the surgical site for 60-secs seconds without suction to facilitate adsorption and interaction with the mineralized tissues. Excess solutions will gently be aspirated without additional irrigation to preserve the bioactive layer. The flap will be repositioned and sutured using microsurgical techniques. |
| Control group | Active comparator | Procedure: conventional endodontic surgeryconventional endodontic microsurgery will be performed |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Bone Bioactive Liquid in endosurgeryA volume of bone bioactive liquid (BBL) (Theravex Tissue Care Plus) will be used depending on the size of lesion calculated using standard equation (π/6×D×W×H) and based upon what was suggested in implant surgery . The solution will be delivered to the bony crypt and root-end surface using a sterile syringe with a blunt needle to ensure complete coverage of the exposed bone walls and resected root surface. The BBL will remain in passive contact with the surgical site for 60-secs seconds without suction to facilitate adsorption and interaction with the mineralized tissues. Excess solutions will gently be aspirated without additional irrigation to preserve the bioactive layer. The flap will be repositioned and sutured using microsurgical techniques. | Other | BBL group |
| conventional endodontic surgeryconventional endodontic microsurgery will be performed | Procedure or surgery | Control group |
Primary outcome
Periapical bone healing assessed radiographically using CBCT
Time frame: 1 year
Preoperative CBCT will be taken. CBCT scans will be obtained.Another scan will be taken after 6 months with cumulative exposure pre and post approximately 240 µSv (0.24 mSv), which is comparable to nearly 24 days of natural background radiation exposure.
1 secondary outcome
Expression levels of inflammatory mediator
Time frame: 10 days
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 16 Oct 2026.
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 study testing Bone Bioactive Liquid in endosurgery and conventional endodontic surgery in people with Patients Diagnosed With Persistent Apical Periodontitis in Maxillary Anterior Regions Require Endodontic Microsurgery, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 16 Oct 2026. 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?
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?
Periapical bone healing assessed radiographically using CBCT (time frame: 1 year). 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 16 Oct 2026.