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NCT Number: NCT07611123

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

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

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Key information

Conditions

Tooth Extraction Site Healing

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, King Abdulaziz University

Jeddah, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Normal Saline

Other

Sterile isotonic saline solution used as a control intervention. Participants were instructed to rinse according to the study protocol.

chlorhexidine (CHX)

Drug

Chlorhexidine gluconate solution (commonly 0.12%) used as an antimicrobial oral rinse following standard postoperative instructions.

Theravex Bioactive Solutions (Tissue Care Plus and Oral)

Drug

A bioactive mineral-based oral rinse designed to support postoperative oral tissue healing. Participants followed the same rinsing protocol as other groups.

Primary outcomes

  1. Early Soft Tissue Healing of the Extraction Socket

    Time frame: 7 days

    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.

Secondary outcomes

  1. Postoperative Pain Intensity

    Time frame: 7 days

    Assessment of postoperative pain intensity using a Visual Analog Scale (VAS) ranging from 0 to 10, where higher scores indicate greater pain intensity.

  2. Soft Tissue Healing Percentage (3D Analysis)

    Time frame: Day 3 to Day 7 post-extraction

    Quantitative assessment of soft tissue healing using 3D intraoral scanning and digital analysis to measure the percentage of wound closure.

  3. Clinical Soft Tissue Appearance

    Time frame: Day 3 and Day 7 post-extraction

    Clinical evaluation of soft tissue healing based on visual assessment of tissue closure, inflammation, edema, and overall wound appearance during follow-up visits.

  4. Patient-Reported Postoperative Comfort

    Time frame: Day 3 and Day 7 post-extraction.

    Assessment of patient-reported postoperative comfort and oral function during the healing period using standardized clinical follow-up questionnaires.

Sponsors and collaborators

Lead sponsor

Biointelligent Technology Systems SL

Industry

Collaborators

  • King Abdulaziz University

Registry information

Official study title

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

Acronym: Bioactive Mine

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 28, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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