Wound Healing TimeNCT07580599
Enhanced Early Soft-Tissue Healing With THERAVEX Technology
A study testing THERAVEX Total Oral Care Plus, Chlorhexidine 0.12% (Paroex) and Warm saline in people with Wound Healing Time, run by Biointelligent Technology Systems SL at 1 site in Lebanon.
Trial summary
randomized, double-blind clinical trial aims to evaluate the effect of different postoperative mouthwashes on early soft-tissue healing following tooth extraction Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Healing Time
- What is being tested?
- THERAVEX Total Oral Care Plus, Chlorhexidine 0.12% (Paroex) and Warm saline
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteLebanon
- Study dates
- 10 Dec 2024to 1 May 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥18 years. Systemically healthy individuals. Patients requiring non-surgical tooth extraction of one to three teeth. Stable periodontal condition and adequate oral hygiene. Ability and willingness to comply with study procedures. Provision of written informed consent.
Who cannot join
- Use of systemic antibiotics within the previous 3 months. Pregnancy or breastfeeding. Presence of infectious diseases or active oral infections. Immunosuppressive conditions or ongoing immunosuppressive therapy. History of bisphosphonate use. History of radiotherapy or chemotherapy. Heavy smoking habits. Uncontrolled systemic diseases. Any condition known to interfere with bone or soft-tissue healing.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of New Bone Bioactive Liquid (BBL), 0.12% Chlorhexidine and Saline Solution Mouthwashes for Socket Healing One Week Postoperatively: A Randomized, Double Blinded Clinical Study
randomized, double-blind clinical trial aims to evaluate the effect of different postoperative mouthwashes on early soft-tissue healing following tooth extraction
Read the detailed description
his randomized, double-blind clinical trial aims to evaluate the effect of different postoperative mouthwashes on early soft-tissue healing following tooth extraction. The study specifically investigates the efficacy of a mineral-based ionic oral rinse (THERAVEX Total Oral Care Plus) compared with 0.12% chlorhexidine and warm saline solution.
A total of 92 extraction sites from systemically healthy adult patients undergoing non-surgical tooth extraction were included. Participants were allocated to one of three intervention groups and followed for a period of 7 days. Intraoral digital scans were obtained immediately after extraction and at follow-up, and healing was assessed using three-dimensional surface analysis to quantify reduction in wound area over time.
The primary objective is to determine whether modulation of the local ionic microenvironment using THERAVEX Technology enhances early soft-tissue healing compared with conventional postoperative mouthwashes. Secondary analyses evaluate the influence of clinical variables such as sex, extraction site location, and dental arch on healing outcomes.
- Conditions
- Wound Healing Time
- Being tested
- THERAVEX Total Oral Care Plus, Chlorhexidine 0.12% (Paroex), Warm saline
- Keywords
- THERAVEX Technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THERAVEX Total Oral Care PlusDevice
Participants used a mineral-based ionic oral rinse containing calcium, magnesium, and phosphate species. The mouthwash was administered according to the manufacturer's instructions, starting 12 hours after tooth extraction, with rinsing performed twice daily for approximately one minute over a 7-day postoperative period.
Chlorhexidine 0.12% (Paroex)Device
Participants used a 0.12% chlorhexidine oral rinse, starting 12 hours after extraction, rinsing twice daily for approximately one minute for 7 days.
Warm salineOther
Participants used a warm saline solution prepared by dissolving one teaspoon of salt in approximately 240 mL of lukewarm water, rinsing twice daily for approximately one minute for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| THERAVEX Total Oral Care Plus | Experimental | THERAVEX Total Oral Care Plus Receives: Device: THERAVEX Total Oral Care Plus; Device: Chlorhexidine 0.12% (Paroex); Other: Warm saline |
| Chlorhexidine 0.12% Oral Rinse (Paroex) | Experimental | Paroex Receives: Device: THERAVEX Total Oral Care Plus; Device: Chlorhexidine 0.12% (Paroex); Other: Warm saline |
| Warm Saline Rinse | Placebo comparator | Warm Saline Rinse Receives: Device: THERAVEX Total Oral Care Plus; Device: Chlorhexidine 0.12% (Paroex); Other: Warm saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Mouthwash Type on Healing
Comparison of healing percentage between intervention groups (THERAVEX, chlorhexidine, and saline) using linear mixed-effects models. Early Healing Index (EHI)
Measured: 7 DAYS
Early Soft-Tissue Healing Percentage
Percentage of soft-tissue healing at 7 days following tooth extraction, quantified by three-dimensional digital intraoral scanning and surface analysis. Healing was defined as the reduction in wound surface area between baseline (immediately post-extraction) and day 7. Early Healing Index (EHI)
Measured: 7 DAYS
Secondary outcomes (1)
Effect of Mouthwash Type on Healing
Comparison of healing percentage between intervention groups (THERAVEX, chlorhexidine, and saline) using linear mixed-effects models.Early Healing Index (EHI)
Measured: 7 DAYS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start10 Dec 2024
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound Healing TimeStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biointelligent Technology Systems SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580599
- Sponsor's protocol ID
- Tfemd-2025-31
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant Data (IPD) that will be shared include de-identified datasets underlying the reported results, including baseline demographic and clinical characteristics, treatment allocation, intraoral digital scan-derived measurements of wound surface area, calculated healing percentages, and variables related to extraction site characteristics (sex, extraction zone, and dental arch).
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of New Bone Bioactive Liquid (BBL), 0.12% Chlorhexidine and Saline Solution Mouthwashes for Socket Healing One Week Postoperatively: A Randomized, Double Blinded Clinical Study
- ClinicalTrials.gov ID
- NCT07580599
- Acronym / sponsor ID
- Tfemd-2025-31
- Conditions
- Wound Healing Time
- Keywords
- THERAVEX Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Biointelligent Technology Systems SLIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 12 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.
randomized, double-blind clinical trial aims to evaluate the effect of different postoperative mouthwashes on early soft-tissue healing following tooth extraction
Detailed description
his randomized, double-blind clinical trial aims to evaluate the effect of different postoperative mouthwashes on early soft-tissue healing following tooth extraction. The study specifically investigates the efficacy of a mineral-based ionic oral rinse (THERAVEX Total Oral Care Plus) compared with 0.12% chlorhexidine and warm saline solution.
A total of 92 extraction sites from systemically healthy adult patients undergoing non-surgical tooth extraction were included. Participants were allocated to one of three intervention groups and followed for a period of 7 days. Intraoral digital scans were obtained immediately after extraction and at follow-up, and healing was assessed using three-dimensional surface analysis to quantify reduction in wound area over time.
The primary objective is to determine whether modulation of the local ionic microenvironment using THERAVEX Technology enhances early soft-tissue healing compared with conventional postoperative mouthwashes. Secondary analyses evaluate the influence of clinical variables such as sex, extraction site location, and dental arch on healing outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| THERAVEX Total Oral Care Plus | Experimental | Device: THERAVEX Total Oral Care Plus, Device: Chlorhexidine 0.12% (Paroex), Other: Warm salineTHERAVEX Total Oral Care Plus |
| Chlorhexidine 0.12% Oral Rinse (Paroex) | Experimental | Device: THERAVEX Total Oral Care Plus, Device: Chlorhexidine 0.12% (Paroex), Other: Warm salineParoex |
| Warm Saline Rinse | Placebo comparator | Device: THERAVEX Total Oral Care Plus, Device: Chlorhexidine 0.12% (Paroex), Other: Warm salineWarm Saline Rinse |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged ≥18 years. Systemically healthy individuals. Patients requiring non-surgical tooth extraction of one to three teeth. Stable periodontal condition and adequate oral hygiene. Ability and willingness to comply with study procedures. Provision of written informed consent.
Key exclusion criteria (2 listed)
- Use of systemic antibiotics within the previous 3 months. Pregnancy or breastfeeding. Presence of infectious diseases or active oral infections. Immunosuppressive conditions or ongoing immunosuppressive therapy. History of bisphosphonate use. History of radiotherapy or chemotherapy. Heavy smoking habits. Uncontrolled systemic diseases. Any condition known to interfere with bone or soft-tissue healing.
- -
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 |
|---|---|---|
| THERAVEX Total Oral Care PlusParticipants used a mineral-based ionic oral rinse containing calcium, magnesium, and phosphate species. The mouthwash was administered according to the manufacturer's instructions, starting 12 hours after tooth extraction, with rinsing performed twice daily for approximately one minute over a 7-day postoperative period. | Device | Chlorhexidine 0.12% Oral Rinse (Paroex), THERAVEX Total Oral Care Plus, Warm Saline Rinse |
| Chlorhexidine 0.12% (Paroex)Participants used a 0.12% chlorhexidine oral rinse, starting 12 hours after extraction, rinsing twice daily for approximately one minute for 7 days. | Device | Chlorhexidine 0.12% Oral Rinse (Paroex), THERAVEX Total Oral Care Plus, Warm Saline Rinse |
| Warm salineParticipants used a warm saline solution prepared by dissolving one teaspoon of salt in approximately 240 mL of lukewarm water, rinsing twice daily for approximately one minute for 7 days. | Other | Chlorhexidine 0.12% Oral Rinse (Paroex), THERAVEX Total Oral Care Plus, Warm Saline Rinse |
Primary outcome
Effect of Mouthwash Type on Healing
Time frame: 7 DAYS
Comparison of healing percentage between intervention groups (THERAVEX, chlorhexidine, and saline) using linear mixed-effects models. Early Healing Index (EHI)
Early Soft-Tissue Healing Percentage
Time frame: 7 DAYS
Percentage of soft-tissue healing at 7 days following tooth extraction, quantified by three-dimensional digital intraoral scanning and surface analysis. Healing was defined as the reduction in wound surface area between baseline (immediately post-extraction) and day 7. Early Healing Index (EHI)
1 secondary outcome
Effect of Mouthwash Type on Healing
Time frame: 7 DAYS
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 3 Jun 2026.
- Individual participant dataSharing planned: Yes. Individual Participant Data (IPD) that will be shared include de-identified datasets underlying the reported results, including baseline demographic and clinical characteristics, treatment allocation, intraoral digital scan-derived measurements of wound surface area, calculated healing percentages, and variables related to extraction site characteristics (sex, extraction zone, and dental arch).
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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 THERAVEX Total Oral Care Plus, Chlorhexidine 0.12% (Paroex) and Warm saline in people with Wound Healing Time, run by Biointelligent Technology Systems SL at 1 site in Lebanon.
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 2 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 3 Jun 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 Lebanon. 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?
Effect of Mouthwash Type on Healing (time frame: 7 DAYS). The study lists 2 primary outcomes in all. 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 3 Jun 2026.