Enhanced Early Soft-Tissue Healing With… | Clinical Trial

Key information

Conditions

Wound Healing Time

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Joseph University of Beirut

Beirut, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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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Treatment and study plan

THERAVEX Total Oral Care Plus

Device

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 saline

Other

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.

Primary outcomes

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)

Secondary outcomes

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)

Other outcomes

Influence of Clinical Variables on Healing

Time frame: 7 DAYS

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)
Safety and Clinical Outcomes

Time frame: 7 DAYS

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)

Sponsors and collaborators

Lead sponsor

Biointelligent Technology Systems SL

Industry

Registry information

Official study 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

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: May 12, 2026
Registry last updated: Jun 3, 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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