Tooth Extraction Site HealingBioactive MineNCT07611123
Effect of a Bioactive Mineral-Ionic Mouthrinse on Periodontal Soft Tissue Healing
A study testing Normal Saline, chlorhexidine (CHX) and Theravex Bioactive Solutions (Tissue Care Plus and Oral) in people with Tooth Extraction Site Healing, run by Biointelligent Technology Systems SL at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Tooth Extraction Site Healing
- What is being tested?
- Normal Saline, chlorhexidine (CHX) and Theravex Bioactive Solutions (Tissue Care Plus and Oral)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 28 Apr 2026to 10 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Faculty of Dentistry, King Abdulaziz University
Jeddah
About this study
Official 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
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.
Read more
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
Read the 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.
- Conditions
- Tooth Extraction Site Healing
- Being tested
- Normal Saline, chlorhexidine (CHX), Theravex Bioactive Solutions (Tissue Care Plus and Oral)
- Keywords
- THERAVEX, THERAVEX REGENERA TOTAL ORAL CARE PLUS, THERAVEX TECHNOLOGY
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal SalineOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline | Placebo comparator | Placebo Receives: Other: Normal Saline; Drug: chlorhexidine (CHX); Drug: Theravex Bioactive Solutions (Tissue Care Plus and Oral) |
| Chlorhexidine (CHX) | Experimental | Chlorhexidine (CHX) Receives: Other: Normal Saline; Drug: chlorhexidine (CHX); Drug: Theravex Bioactive Solutions (Tissue Care Plus and Oral) |
| THERAVEX Total Oral Care Plus | Experimental | THERAVEX Total Oral Care Plus Receives: Other: Normal Saline; Drug: chlorhexidine (CHX); Drug: Theravex Bioactive Solutions (Tissue Care Plus and Oral) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 3 and Day 7 post-extraction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start28 Apr 2026
- Primary completion10 May 2026
- Study completion10 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth Extraction Site HealingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biointelligent Technology Systems SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- King Abdulaziz University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611123
- Sponsor's protocol ID
- 164-10-25
- Other IDs
- 164-10-25
- Acronym
- Bioactive Mine
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07611123
- Acronym / sponsor ID
- Bioactive Mine / 164-10-25
- Conditions
- Tooth Extraction Site Healing
- Keywords
- THERAVEX, THERAVEX REGENERA TOTAL ORAL CARE PLUS, THERAVEX TECHNOLOGY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Biointelligent Technology Systems SLIndustry (pharma, biotech, devices)
- Collaborators
- King Abdulaziz University
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- 10 May 2026 (actual)
- Study completion
- 10 May 2026 (actual)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Saline | Placebo comparator | Other: Normal Saline, Drug: chlorhexidine (CHX), Drug: Theravex Bioactive Solutions (Tissue Care Plus and Oral)Placebo |
| Chlorhexidine (CHX) | Experimental | Other: Normal Saline, Drug: chlorhexidine (CHX), Drug: Theravex Bioactive Solutions (Tissue Care Plus and Oral)Chlorhexidine (CHX) |
| THERAVEX Total Oral Care Plus | Experimental | Other: Normal Saline, Drug: chlorhexidine (CHX), Drug: Theravex Bioactive Solutions (Tissue Care Plus and Oral)THERAVEX Total Oral Care Plus |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal SalineSterile isotonic saline solution used as a control intervention. Participants were instructed to rinse according to the study protocol. | Other | Chlorhexidine (CHX), Normal Saline, THERAVEX Total Oral Care Plus |
| chlorhexidine (CHX)Chlorhexidine gluconate solution (commonly 0.12%) used as an antimicrobial oral rinse following standard postoperative instructions. | Drug | Chlorhexidine (CHX), Normal Saline, THERAVEX Total Oral Care Plus |
| 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. | Drug | Chlorhexidine (CHX), Normal Saline, THERAVEX Total Oral Care Plus |
Primary outcome
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.
4 secondary outcomes
Postoperative Pain Intensity
Time frame: 7 days
Soft Tissue Healing Percentage (3D Analysis)
Time frame: Day 3 to Day 7 post-extraction
Clinical Soft Tissue Appearance
Time frame: Day 3 and Day 7 post-extraction
Patient-Reported Postoperative Comfort
Time frame: Day 3 and Day 7 post-extraction.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal Saline, chlorhexidine (CHX) and Theravex Bioactive Solutions (Tissue Care Plus and Oral) in people with Tooth Extraction Site Healing, run by Biointelligent Technology Systems SL at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Soft Tissue Healing of the Extraction Socket (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.