Effect of a Bioactive Mineral-Ionic Mouthrinse on Periodontal Soft Tissue Healing and Postoperative Pain After Tooth Extraction: A Double-Blind Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 1
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants, outcome assessors, and data analysts were blinded to group allocation. The mouth rinses were prepared in identical containers with the same appearance, labeling, and volume to ensure indistinguishability between interventions.
The solutions were matched as closely as possible in color and presentation. Allocation concealment was maintained using coded labeling, and the randomization code was kept by an independent third party not involved in patient recruitment, treatment, or outcome assessment.
Blinding was maintained throughout the study period and was only broken after completion of data analysis.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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