Effect of a Bioactive Mineral-Ionic Mouthrinse on Periodontal Soft Tissue Healing

NCT07611123 | Completed DMC

• 1 other identifier: 164-10-25
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tooth Extraction Site Healing

Keywords

THERAVEX; THERAVEX REGENERA TOTAL ORAL CARE PLUS; THERAVEX TECHNOLOGY

Outcome Measures

Primary Outcomes (1)

• Early Soft Tissue Healing of the Extraction Socket

  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.

  7 days

Secondary Outcomes (4)

• Postoperative Pain Intensity

  7 days

• Soft Tissue Healing Percentage (3D Analysis)

  Day 3 to Day 7 post-extraction

• Clinical Soft Tissue Appearance

  Day 3 and Day 7 post-extraction

• Patient-Reported Postoperative Comfort

  Day 3 and Day 7 post-extraction.

Study Arms (3)

Normal Saline

PLACEBO COMPARATOR

Placebo

Other: Normal Saline; Drug: chlorhexidine (CHX); Drug: Theravex Bioactive Solutions (Tissue Care Plus and Oral)

Chlorhexidine (CHX)

EXPERIMENTAL

Chlorhexidine (CHX)

Other: Normal Saline; Drug: chlorhexidine (CHX); Drug: Theravex Bioactive Solutions (Tissue Care Plus and Oral)

THERAVEX Total Oral Care Plus

EXPERIMENTAL

THERAVEX Total Oral Care Plus

Other: Normal Saline; Drug: chlorhexidine (CHX); Drug: Theravex Bioactive Solutions (Tissue Care Plus and Oral)

Interventions

Normal Saline OTHER

Sterile isotonic saline solution used as a control intervention. Participants were instructed to rinse according to the study protocol.

Chlorhexidine (CHX); Normal Saline; THERAVEX Total Oral Care Plus

chlorhexidine (CHX) DRUG

Chlorhexidine gluconate solution (commonly 0.12%) used as an antimicrobial oral rinse following standard postoperative instructions.

Chlorhexidine (CHX); Normal Saline; THERAVEX Total Oral Care Plus

Theravex Bioactive Solutions (Tissue Care Plus and Oral) DRUG

A bioactive mineral-based oral rinse designed to support postoperative oral tissue healing. Participants followed the same rinsing protocol as other groups.

Chlorhexidine (CHX); Normal Saline; THERAVEX Total Oral Care Plus

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biointelligent Technology Systems SL: lead
• King Abdulaziz University: collaborator

Study Sites (1)

Faculty of Dentistry, King Abdulaziz University

Jeddah, Saudi Arabia

Location

MeSH Terms

Interventions

Saline Solution; Chlorhexidine

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

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

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 28, 2026
• Study Start: April 28, 2026
• Primary Completion: May 10, 2026
• Study Completion: May 10, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.

Locations

SA (1)