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randomized, double-blind clinical trial aims to evaluate the effect of different postoperative mouthwashes on early soft-tissue healing following tooth extraction
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THERAVEX Total Oral Care Plus | Experimental | THERAVEX Total Oral Care Plus |
|
| Chlorhexidine 0.12% Oral Rinse (Paroex) | Experimental | Paroex |
|
| Warm Saline Rinse | Placebo Comparator | Warm Saline Rinse |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Joseph University of Beirut | Beirut | Lebanon |
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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|
| 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. |
|
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 |