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NOT YET RECRUITING
NCT07879482
NA

Bone-Bioactive Liquid as an Adjunct in Endodontic Surgery

Sponsor: Ain Shams University

View on ClinicalTrials.gov

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. 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

Official title: Bone-Bioactive Liquid as an Adjunct in Endodontic Surgery: Effects on Postoperative Healing and Inflammatory Mediator Expression. (Randomized Controlled Clinical Trial)

Key Details

Gender

All

Age Range

21 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

34

Start Date

2026-11-01

Completion Date

2027-12

Last Updated

2026-10-16

Healthy Volunteers

Yes

Interventions

OTHER

Bone Bioactive Liquid in endosurgery

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.

PROCEDURE

conventional endodontic surgery

conventional endodontic microsurgery will be performed