Effect of a Bioactive Mineral-Ionic Mouthrinse on Periodontal Soft Tissue Healing (Bioactive Mine)
Effect of a Bioactive Mineral-Ionic Mouthrinse on Periodontal Soft Tissue Healing and Postoperative Pain After Tooth Extraction: A Double-Blind Randomized Clinical Trial
This randomized, double-blinded clinical trial was designed to evaluate the effects of a bioactive mineral-ionic mouthrinse (THERAVEX® Total Oral Care Plus) on postoperative healing and patient comfort following simple tooth extraction. Tooth extraction is one of the most common dental procedures and is frequently associated with postoperative pain, inflammation, and delayed soft tissue healing. Conventional mouthrinses such as chlorhexidine are widely used for their antimicrobial properties; however, alternative approaches aimed at supporting the physiological healing process are increasingly being investigated.
A total of 94 systemically healthy patients requiring simple tooth extraction were enrolled and randomly allocated into three parallel groups receiving either a bioactive mineral-ionic mouthrinse, chlorhexidine 0.12%, or normal saline as postoperative oral rinses. Participants and investigators were blinded to group allocation throughout the study period.
The primary objective of the study was to assess early soft tissue healing of the extraction socket using standardized clinical measurements of buccolingual (BL) and mesiodistal (MD) socket dimensions at different postoperative time points. Secondary objectives included the evaluation of postoperative pain using a visual analog scale (VAS), as well as clinical assessment of tissue response during the healing period.
The study aims to investigate whether a bioactive mineral-ionic oral rinse may serve as a supportive postoperative strategy for enhancing early wound healing and improving patient-reported comfort after dental extraction procedures
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Tooth extraction is one of the most frequently performed procedures in clinical dentistry and is commonly associated with postoperative discomfort, inflammation, and temporary impairment of oral function during the healing period. Early soft tissue closure and patient comfort are important factors influencing postoperative recovery and overall treatment experience.
Postoperative oral rinses are routinely prescribed following extraction procedures to support oral hygiene and reduce local microbial accumulation. Chlorhexidine-based mouthrinses are widely used due to their antiseptic properties; however, interest has increased in alternative approaches that may additionally support the biological processes involved in tissue repair.
Bioactive mineral-ionic formulations have been proposed as supportive agents capable of modulating the local wound environment through physicochemical mechanisms that may contribute to tissue stabilization and postoperative comfort. The present study was designed to clinically investigate the postoperative use of a bioactive mineral-ionic oral rinse in patients undergoing simple tooth extraction.
This study was conducted as a randomized, double-blinded, parallel-group clinical trial comparing a bioactive mouthrinse with commonly used postoperative rinsing approaches. Clinical follow-up evaluations were performed during the early healing phase after extraction in order to assess tissue response and patient-reported postoperative experience under standardized clinical conditions.
The purpose of this investigation is to further explore the potential role of bioactive oral care strategies as supportive postoperative adjuncts in routine dental extraction procedures.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Jeddah, Saudi-Arabien
- Faculty of Dentistry, King Abdulaziz University
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
Adults aged 18 years and older Patients requiring simple tooth extraction Systemically healthy individuals (ASA I or II) Ability and willingness to follow study instructions Provision of written informed consent
Exclusion Criteria:
Patients with systemic conditions that may impair wound healing (e.g., uncontrolled diabetes, immunosuppressive disorders) Use of antibiotics, anti-inflammatory drugs, or antiseptic mouth rinses within 7 days prior to the procedure Presence of acute infection at the extraction site History of hypersensitivity or allergy to any component of the study products Pregnant or breastfeeding women Smokers (or heavy smokers, if aplica según tu protocolo) Patients with poor oral hygiene or periodontal disease affecting the study site Participation in another clinical study within the last 30 days
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Placebo-Komparator: Normale Kochsalzlösung
Placebo
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Sterile isotonic saline solution used as a control intervention.
Participants were instructed to rinse according to the study protocol.
Chlorhexidine gluconate solution (commonly 0.12%) used as an antimicrobial oral rinse following standard postoperative instructions.
A bioactive mineral-based oral rinse designed to support postoperative oral tissue healing.
Participants followed the same rinsing protocol as other groups.
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Experimental: THERAVEX Total Oral Care Plus
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Sterile isotonic saline solution used as a control intervention.
Participants were instructed to rinse according to the study protocol.
Chlorhexidine gluconate solution (commonly 0.12%) used as an antimicrobial oral rinse following standard postoperative instructions.
A bioactive mineral-based oral rinse designed to support postoperative oral tissue healing.
Participants followed the same rinsing protocol as other groups.
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Experimental: Chlorhexidine (CHX)
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Sterile isotonic saline solution used as a control intervention.
Participants were instructed to rinse according to the study protocol.
Chlorhexidine gluconate solution (commonly 0.12%) used as an antimicrobial oral rinse following standard postoperative instructions.
A bioactive mineral-based oral rinse designed to support postoperative oral tissue healing.
Participants followed the same rinsing protocol as other groups.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Early Soft Tissue Healing of the Extraction Socket
Zeitfenster: 7 days
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Assessment of early postoperative soft tissue healing following tooth extraction using clinical measurements of buccolingual (BL) and mesiodistal (MD) socket dimensions.
Measurements will be performed at baseline (Day 0), Day 3, and Day 7 using standardized periodontal measurement techniques to evaluate dimensional changes during the healing process.
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7 days
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Postoperative Pain Intensity
Zeitfenster: 7 days
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Assessment of postoperative pain intensity using a Visual Analog Scale (VAS) ranging from 0 to 10, where higher scores indicate greater pain intensity.
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7 days
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Soft Tissue Healing Percentage (3D Analysis)
Zeitfenster: Day 3 to Day 7 post-extraction
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Quantitative assessment of soft tissue healing using 3D intraoral scanning and digital analysis to measure the percentage of wound closure.
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Day 3 to Day 7 post-extraction
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Clinical Soft Tissue Appearance
Zeitfenster: Day 3 and Day 7 post-extraction
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Clinical evaluation of soft tissue healing based on visual assessment of tissue closure, inflammation, edema, and overall wound appearance during follow-up visits.
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Day 3 and Day 7 post-extraction
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Patient-Reported Postoperative Comfort
Zeitfenster: Day 3 and Day 7 post-extraction.
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Assessment of patient-reported postoperative comfort and oral function during the healing period using standardized clinical follow-up questionnaires.
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Day 3 and Day 7 post-extraction.
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Mitarbeiter und Ermittler
Mitarbeiter
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 164-10-25 (Andere Kennung: Department of Periodontics, Faculty of Dentistry, King Abdulaziz University, Jeddah, KSA)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Description:
De-identified individual participant data (IPD) that underlie the results reported in this study will be made available upon reasonable request. Data will include demographic information, outcome measures, and relevant clinical variables.
Time Frame:
Data will be available beginning 6 months after publication and ending 5 years following publication.
Access Criteria:
Data will be shared with qualified researchers who provide a methodologically sound proposal. Requests should be directed to the corresponding author. Access will be granted after review and approval of the proposal, and a data access agreement may be required.
IPD-Sharing-Zeitrahmen
IPD-Sharing-Zugriffskriterien
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
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