Clinical Trial

Effect of a Bioactive Mineral-Ionic Mouthrinse on Periodontal Soft Tissue Healing

Study acronym: Bioactive Mine
Completed
View on ClinicalTrials.gov →
Summary
This randomized, double-blinded clinical trial was designed to evaluate the effects of a bioactive mineral-ionic mouthrinse (THERAVEX® Total Oral Care Plus) on postoperative healing and patient comfort following simple tooth extraction. Tooth extraction is one of the most common dental procedures and is frequently associated with postoperative pain, inflammation, and delayed soft tissue healing. Conventional mouthrinses such as chlorhexidine are widely used for their antimicrobial properties; however, alternative approaches aimed at supporting the physiological healing process are increasingly being investigated. A total of 94 systemically healthy patients requiring simple tooth extraction were enrolled and randomly allocated into three parallel groups receiving either a bioactive mineral-ionic mouthrinse, chlorhexidine 0.12%, or normal saline as postoperative oral rinses. Participants and investigators were blinded to group allocation throughout the study period. The primary objective of the study was to assess early soft tissue healing of the extraction socket using standardized clinical measurements of buccolingual (BL) and mesiodistal (MD) socket dimensions at different postoperative time points. Secondary objectives included the evaluation of postoperative pain using a visual analog scale (VAS), as well as clinical assessment of tissue response during the healing period. The study aims to investigate whether a bioactive mineral-ionic oral rinse may serve as a supportive postoperative strategy for enhancing early wound healing and improving patient-reported comfort after dental extraction procedures
Protocol Amendment History 1 change
notable Primary completion pushed: 2025-11-02 -> 2026-05-10 2026-05-30
Trial Details
NCT Number NCT07611123
Lead Sponsor Biointelligent Technology Systems SL
Collaborators: King Abdulaziz University
Conditions Tooth Extraction Site Healing
Enrollment 94 participants
Start Date 2026-04-28
Primary Completion 2026-05-10 (estimated)
Study Completion 2026-05-10 (estimated)
Updated on ClinicalTrials.gov 2026-05-29