An interventional study of Bone Bioactive Liquid in endosurgery and conventional endodontic surgery in Patients Diagnosed With Persistent Apical Periodontitis in Maxillary Anterior Regions Require Endodontic Microsurgery, sponsored by Ain Shams University. Not yet recruiting. Open to participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
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
Ain Shams University is the lead sponsor of 1,930 studies on the registry; 433 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Inclusion Criteria: Patients diagnosed with persistent apical periodontitis in maxillary anterior regions require endodontic microsurgery
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.
Other: Bone Bioactive Liquid in endosurgery
conventional endodontic microsurgery will be performed
Procedure: conventional endodontic surgery
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 microsurgery will be performed
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.
Time frame: 1 year
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.
Time frame: 10 days
Soft tissue healing
The evaluation of soft tissue healing will be conducted at 10th day postoperative using the Early Healing Score (EHS). The Early Healing Score (EHS) is based on three clinical parameters: re-epithelialization (CSR), hemostasis (CSH), and inflammation (CSI).
Time frame: 10 days
Postoperative pain assessment
Study participants will complete preoperative questionnaires to assess preoperative pain intensity using VAS
Time frame: 7days
No study locations are listed for this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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