Enhanced Early Soft-Tissue Healing With THERAVEX Technology

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

Study Overview

• Status: Completed
• Conditions: Wound Healing Time
• Intervention / Treatment: Device: THERAVEX Total Oral Care Plus; Device: Chlorhexidine 0.12% (Paroex); Other: Warm saline

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 Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Saint Joseph University of Beirut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

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Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: THERAVEX Total Oral Care Plus	Device: THERAVEX Total Oral Care Plus; 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.; Device: 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.; Other: Warm saline; 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.
Experimental: Chlorhexidine 0.12% Oral Rinse (Paroex); Paroex	Device: THERAVEX Total Oral Care Plus; 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.; Device: 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.; Other: Warm saline; 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.
Placebo Comparator: Warm Saline Rinse	Device: THERAVEX Total Oral Care Plus; 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.; Device: 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.; Other: Warm saline; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	7 DAYS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	7 DAYS

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Influence of Clinical Variables on Healing	Assessment of the effect of sex, extraction site location (anterior vs posterior), and dental arch (maxilla vs mandible) on healing outcomes. Early Healing Index (EHI)	7 DAYS
Safety and Clinical Outcomes	Change in pain intensity measured using the Visual Analog Scale (VAS; 0-10, where 0 indicates no pain and 10 indicates worst possible pain) at Day 7 post-extraction Visual Analog Scale (VAS)	7 DAYS

Collaborators and Investigators

• Sponsor: Biointelligent Technology Systems SL

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2024
• Primary Completion (Actual): May 1, 2025
• Study Completion (Actual): May 1, 2025

Study Registration Dates

• First Submitted: April 28, 2026
• First Submitted That Met QC Criteria: May 5, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: THERAVEX Technology
• Other Study ID Numbers: Tfemd-2025-31

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

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