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

Effect of a Bioactive Mineral-Ionic Mouthrinse on Periodontal Soft Tissue Healing and Postoperative Pain After Tooth Extraction: A Double-Blind Randomized Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Tooth Extraction Site Healing
• Intervention / Treatment: Other: Normal Saline; Drug: chlorhexidine (CHX); Drug: Theravex Bioactive Solutions (Tissue Care Plus and Oral)

Detailed Description

Tooth extraction is one of the most frequently performed procedures in clinical dentistry and is commonly associated with postoperative discomfort, inflammation, and temporary impairment of oral function during the healing period. Early soft tissue closure and patient comfort are important factors influencing postoperative recovery and overall treatment experience.

Postoperative oral rinses are routinely prescribed following extraction procedures to support oral hygiene and reduce local microbial accumulation. Chlorhexidine-based mouthrinses are widely used due to their antiseptic properties; however, interest has increased in alternative approaches that may additionally support the biological processes involved in tissue repair.

Bioactive mineral-ionic formulations have been proposed as supportive agents capable of modulating the local wound environment through physicochemical mechanisms that may contribute to tissue stabilization and postoperative comfort. The present study was designed to clinically investigate the postoperative use of a bioactive mineral-ionic oral rinse in patients undergoing simple tooth extraction.

This study was conducted as a randomized, double-blinded, parallel-group clinical trial comparing a bioactive mouthrinse with commonly used postoperative rinsing approaches. Clinical follow-up evaluations were performed during the early healing phase after extraction in order to assess tissue response and patient-reported postoperative experience under standardized clinical conditions.

The purpose of this investigation is to further explore the potential role of bioactive oral care strategies as supportive postoperative adjuncts in routine dental extraction procedures.

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Jeddah, Saudi Arabia
    • Faculty of Dentistry, King Abdulaziz University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Adults aged 18 years and older Patients requiring simple tooth extraction Systemically healthy individuals (ASA I or II) Ability and willingness to follow study instructions Provision of written informed consent

Exclusion Criteria:

Patients with systemic conditions that may impair wound healing (e.g., uncontrolled diabetes, immunosuppressive disorders) Use of antibiotics, anti-inflammatory drugs, or antiseptic mouth rinses within 7 days prior to the procedure Presence of acute infection at the extraction site History of hypersensitivity or allergy to any component of the study products Pregnant or breastfeeding women Smokers (or heavy smokers, if aplica según tu protocolo) Patients with poor oral hygiene or periodontal disease affecting the study site Participation in another clinical study within the last 30 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Normal Saline; Placebo	Other: Normal Saline; Sterile isotonic saline solution used as a control intervention. Participants were instructed to rinse according to the study protocol.; Drug: chlorhexidine (CHX); Chlorhexidine gluconate solution (commonly 0.12%) used as an antimicrobial oral rinse following standard postoperative instructions.; Drug: Theravex Bioactive Solutions (Tissue Care Plus and Oral); A bioactive mineral-based oral rinse designed to support postoperative oral tissue healing. Participants followed the same rinsing protocol as other groups.
Experimental: THERAVEX Total Oral Care Plus	Other: Normal Saline; Sterile isotonic saline solution used as a control intervention. Participants were instructed to rinse according to the study protocol.; Drug: chlorhexidine (CHX); Chlorhexidine gluconate solution (commonly 0.12%) used as an antimicrobial oral rinse following standard postoperative instructions.; Drug: Theravex Bioactive Solutions (Tissue Care Plus and Oral); A bioactive mineral-based oral rinse designed to support postoperative oral tissue healing. Participants followed the same rinsing protocol as other groups.
Experimental: Chlorhexidine (CHX)	Other: Normal Saline; Sterile isotonic saline solution used as a control intervention. Participants were instructed to rinse according to the study protocol.; Drug: chlorhexidine (CHX); Chlorhexidine gluconate solution (commonly 0.12%) used as an antimicrobial oral rinse following standard postoperative instructions.; Drug: Theravex Bioactive Solutions (Tissue Care Plus and Oral); A bioactive mineral-based oral rinse designed to support postoperative oral tissue healing. Participants followed the same rinsing protocol as other groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early Soft Tissue Healing of the Extraction Socket	Assessment of early postoperative soft tissue healing following tooth extraction using clinical measurements of buccolingual (BL) and mesiodistal (MD) socket dimensions. Measurements will be performed at baseline (Day 0), Day 3, and Day 7 using standardized periodontal measurement techniques to evaluate dimensional changes during the healing process.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain Intensity	Assessment of postoperative pain intensity using a Visual Analog Scale (VAS) ranging from 0 to 10, where higher scores indicate greater pain intensity.	7 days
Soft Tissue Healing Percentage (3D Analysis)	Quantitative assessment of soft tissue healing using 3D intraoral scanning and digital analysis to measure the percentage of wound closure.	Day 3 to Day 7 post-extraction
Clinical Soft Tissue Appearance	Clinical evaluation of soft tissue healing based on visual assessment of tissue closure, inflammation, edema, and overall wound appearance during follow-up visits.	Day 3 and Day 7 post-extraction
Patient-Reported Postoperative Comfort	Assessment of patient-reported postoperative comfort and oral function during the healing period using standardized clinical follow-up questionnaires.	Day 3 and Day 7 post-extraction.

Collaborators and Investigators

• Sponsor: Biointelligent Technology Systems SL
• Collaborators: King Abdulaziz University

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2026
• Primary Completion (Actual): May 10, 2026
• Study Completion (Actual): May 10, 2026

Study Registration Dates

• First Submitted: May 4, 2026
• First Submitted That Met QC Criteria: May 20, 2026
• First Posted (Actual): May 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: THERAVEX; THERAVEX REGENERA TOTAL ORAL CARE PLUS; THERAVEX TECHNOLOGY
• Additional Relevant MeSH Terms: Organic Chemicals; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions; Solutions; Biguanides; Guanidines; Amidines; Chlorhexidine; Saline Solution
• Other Study ID Numbers: 164-10-25 (Other Identifier: Department of Periodontics, Faculty of Dentistry, King Abdulaziz University, Jeddah, KSA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Description:

De-identified individual participant data (IPD) that underlie the results reported in this study will be made available upon reasonable request. Data will include demographic information, outcome measures, and relevant clinical variables.

Time Frame:

Data will be available beginning 6 months after publication and ending 5 years following publication.

Access Criteria:

Data will be shared with qualified researchers who provide a methodologically sound proposal. Requests should be directed to the corresponding author. Access will be granted after review and approval of the proposal, and a data access agreement may be required.

• IPD Sharing Time Frame: Data will be available beginning 6 months after publication and ending 5 years following publication.
• IPD Sharing Access Criteria: Data will be shared with qualified researchers who provide a methodologically sound proposal. Requests should be directed to the corresponding author. Access will be granted after review and approval of the proposal, and a data access agreement may be required.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No