Comparison of the Efficacy of Boric Acid Mouthwashes in Different Concentrations

Phase 4

Active, not recruiting

• Conditions: Impacted Third Molar Tooth
• Interventions: Drug: Chlorhexidine mouthwash; Procedure: Chlorhexidine mouthwash with boric acid (2%); Procedure: Chlorhexidine mouthwash with boric acid (1.5%); Procedure: Chlorhexidine mouthwash with boric acid (0.1%); Procedure: Chlorhexidine mouthwash with boric acid (2.5%); Procedure: Chlorhexidine mouthwash with boric acid (0.5%); Procedure: Chlorhexidine mouthwash with boric acid (1%); Procedure: Boric acid mouthwash (2%)

• Registration Number: NCT04376268
• Lead Sponsor: Yuzuncu Yıl University

Brief Summary

Surgical removal of impacted third molars is one of the most frequent procedures carried out in the oral and maxillofacial surgery clinics. There are a varying range of postoperative complications including pain, edema and swelling. Antibiotics, analgesics and mouthwashes are usually prescribed for the treatment of these complications. Patients undergoing impacted third molar surgery are frequently prescribed chlorhexidine mouthwashes with/without benzydamine hydrochloride. However, there has been a search for alternatives with anti-inflammatory, antibacterial and analgesic properties as part of the oral care routine following surgical removal of impacted third molars. Thus, this multicenter study was aimed to evaluate the effects of chlorhexidine mouthwashes with different boric acid concentrations (%0.1, %0.5, %1, %1.5, %2 and %2.5), and boric acid mouthwash on the postoperative complications and compared with chlorhexidine mouthwash after the removal of impacted wisdom teeth.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-15
• Study First Submitted: 2020-05-02
• Study First Submitted QC: 2020-05-02
• Study First Posted: 2020-05-06
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-20
• Last Update Posted: 2023-08-22
• Primary Completion: 2023-11-15
• Study Completion: 2023-12-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• absence of any systemic disease
• having impacted mandibular third molar teeth in a similar position
• absence of allergy to any of the drugs used in the study,
• absence of pregnancy/lactating state,
• no history of any medication use during at least 2 week before the operation.

Exclusion Criteria

• not regularly coming to the controls,
• not using their medicines regularly
• using any additional medication that may affect the outcome of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Chlorhexidine gluconate	Chlorhexidine mouthwash	Chlorhexidine is one of the most commonly used medications after tooth extraction. It exhibits a wide spectrum of antiseptic, bactericidal and bacteriostatic effects.
Chlorhexidine mouthwash with boric acid (2%)	Chlorhexidine mouthwash with boric acid (2%)	Due to its antibacterial properties, boric acid is effective on gram (+) and gram (-) microorganisms such as candida albicans, streptococcus mutans, staphylococcus aureus, enterococcus faecalis, enterococcus faesium, escherichia coli, klebsiella pneumonia and pseudomonas aeruginosa. With these features, it is used in periodontology, endodontics and restorative therapy as a antiseptic.
Chlorhexidine mouthwash with boric acid (1.5%)	Chlorhexidine mouthwash with boric acid (1.5%)	Due to its antibacterial properties, boric acid is effective on gram (+) and gram (-) microorganisms such as candida albicans, streptococcus mutans, staphylococcus aureus, enterococcus faecalis, enterococcus faesium, escherichia coli, klebsiella pneumonia and pseudomonas aeruginosa. With these features, it is used in periodontology, endodontics and restorative therapy as a antiseptic.
Chlorhexidine mouthwash with boric acid (0.1%)	Chlorhexidine mouthwash with boric acid (0.1%)	Due to its antibacterial properties, boric acid is effective on gram (+) and gram (-) microorganisms such as candida albicans, streptococcus mutans, staphylococcus aureus, enterococcus faecalis, enterococcus faesium, escherichia coli, klebsiella pneumonia and pseudomonas aeruginosa. With these features, it is used in periodontology, endodontics and restorative therapy as a antiseptic.
Chlorhexidine mouthwash with boric acid (2.5%)	Chlorhexidine mouthwash with boric acid (2.5%)	Due to its antibacterial properties, boric acid is effective on gram (+) and gram (-) microorganisms such as candida albicans, streptococcus mutans, staphylococcus aureus, enterococcus faecalis, enterococcus faesium, escherichia coli, klebsiella pneumonia and pseudomonas aeruginosa. With these features, it is used in periodontology, endodontics and restorative therapy as a antiseptic.
Chlorhexidine mouthwash with boric acid (0.5%)	Chlorhexidine mouthwash with boric acid (0.5%)	Due to its antibacterial properties, boric acid is effective on gram (+) and gram (-) microorganisms such as candida albicans, streptococcus mutans, staphylococcus aureus, enterococcus faecalis, enterococcus faesium, escherichia coli, klebsiella pneumonia and pseudomonas aeruginosa. With these features, it is used in periodontology, endodontics and restorative therapy as a antiseptic.
Chlorhexidine mouthwash with boric acid (1%)	Chlorhexidine mouthwash with boric acid (1%)	Due to its antibacterial properties, boric acid is effective on gram (+) and gram (-) microorganisms such as candida albicans, streptococcus mutans, staphylococcus aureus, enterococcus faecalis, enterococcus faesium, escherichia coli, klebsiella pneumonia and pseudomonas aeruginosa. With these features, it is used in periodontology, endodontics and restorative therapy as a antiseptic.
Boric acid mouthwash (2%)	Boric acid mouthwash (2%)	Due to its antibacterial properties, boric acid is effective on gram (+) and gram (-) microorganisms such as candida albicans, streptococcus mutans, staphylococcus aureus, enterococcus faecalis, enterococcus faesium, escherichia coli, klebsiella pneumonia and pseudomonas aeruginosa. With these features, it is used in periodontology, endodontics and restorative therapy as a antiseptic.

Primary Outcome Measures

Name	Time	Method
Postoperative Pain	Postoperative 7th day	In order to evaluate the postoperative pain, a seven-day scheduled pain diary was given to the patients. To record the level of pain, patients were instructed to rate it on a 10-cm visual analog scales (VAS) was used wherein 0 indicated no pain and 10 indicated the worst pain imaginable.
Postoperative Swelling	Postoperatif 7th day	Facial swelling was assessed using thread and millimeter ruler and five following measurements were taken: Distance I (from angle of the mandible to labial commissure); Distance II (from angle of the mandible to nasal border); Distance III (from angle of the mandible to external corner of the eye); Distance IV (from angle of the mandible to tragus) and Distance V (from angle of the mandible to soft pogonion).
Postoperative Trismus	Postoperative 7th day	The maximum mouth opening (MMO) was measured in millimeters with a caliper from the incisal edge of the right upper and lower incisor teeth. For evaluation of trismus, the percentage of difference in MMO during postoperative period was calculated by subtracting the preoperative measurement from the postoperative measurement then divided by the preoperative measurement and multiplied by 100.

Trial Locations

Locations (1)

Van Yuzuncu Yil University, Faculty of Dentistry; 🇹🇷 Van, Turkey