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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Beirut, Libanon
- Saint Joseph University of Beirut
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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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Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: THERAVEX Total Oral Care Plus
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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.
Participants used a 0.12% chlorhexidine oral rinse, starting 12 hours after extraction, rinsing twice daily for approximately one minute for 7 days.
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.
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Experimenteel: Chlorhexidine 0.12% Oral Rinse (Paroex)
Paroex
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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.
Participants used a 0.12% chlorhexidine oral rinse, starting 12 hours after extraction, rinsing twice daily for approximately one minute for 7 days.
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.
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Placebo-vergelijker: Warm Saline Rinse
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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.
Participants used a 0.12% chlorhexidine oral rinse, starting 12 hours after extraction, rinsing twice daily for approximately one minute for 7 days.
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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Effect of Mouthwash Type on Healing
Tijdsspanne: 7 DAYS
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Comparison of healing percentage between intervention groups (THERAVEX, chlorhexidine, and saline) using linear mixed-effects models.
Early Healing Index (EHI)
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7 DAYS
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Early Soft-Tissue Healing Percentage
Tijdsspanne: 7 DAYS
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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)
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7 DAYS
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Effect of Mouthwash Type on Healing
Tijdsspanne: 7 DAYS
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Comparison of healing percentage between intervention groups (THERAVEX, chlorhexidine, and saline) using linear mixed-effects models.Early Healing Index (EHI)
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7 DAYS
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Influence of Clinical Variables on Healing
Tijdsspanne: 7 DAYS
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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)
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7 DAYS
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Safety and Clinical Outcomes
Tijdsspanne: 7 DAYS
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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)
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7 DAYS
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Medewerkers en onderzoekers
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Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- Tfemd-2025-31
Plan Individuele Deelnemersgegevens (IPD)
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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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