Enhanced Early Soft-Tissue Healing With THERAVEX Technology

NCT07580599 | Completed DMC

• 1 other identifier: Tfemd-2025-31
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

randomized, double-blind clinical trial aims to evaluate the effect of different postoperative mouthwashes on early soft-tissue healing following tooth extraction

Conditions

Wound Healing Time

Keywords

THERAVEX Technology

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Effect of Mouthwash Type on Healing

  7 DAYS

Other Outcomes (2)

• Influence of Clinical Variables on Healing

  7 DAYS

• Safety and Clinical Outcomes

  7 DAYS

Study Arms (3)

THERAVEX Total Oral Care Plus

EXPERIMENTAL

THERAVEX Total Oral Care Plus

Device: THERAVEX Total Oral Care Plus; Device: Chlorhexidine 0.12% (Paroex); Other: Warm saline

Chlorhexidine 0.12% Oral Rinse (Paroex)

EXPERIMENTAL

Paroex

Device: THERAVEX Total Oral Care Plus; Device: Chlorhexidine 0.12% (Paroex); Other: Warm saline

Warm Saline Rinse

PLACEBO COMPARATOR

Warm Saline Rinse

Device: THERAVEX Total Oral Care Plus; Device: Chlorhexidine 0.12% (Paroex); Other: Warm saline

Interventions

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% Oral Rinse (Paroex); THERAVEX Total Oral Care Plus; Warm Saline Rinse

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.

Chlorhexidine 0.12% Oral Rinse (Paroex); THERAVEX Total Oral Care Plus; Warm Saline Rinse

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.

Chlorhexidine 0.12% Oral Rinse (Paroex); THERAVEX Total Oral Care Plus; Warm Saline Rinse

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biointelligent Technology Systems SL: lead

Study Sites (1)

Saint Joseph University of Beirut

Beirut, Lebanon

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 12, 2026
• Study Start: December 10, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: June 3, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

LE (1)