Comparison of the Efficacy of Boric Acid Mouthwashes in Different Concentrations

Comparison of the Efficacy of Boric Acid Mouthwashes in Different Concentrations in the Lower Third Molar Surgery in the Postoperative Period

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Impacted Third Molar Tooth
• Intervention / Treatment: Drug: Chlorhexidine mouthwash; Procedure: Chlorhexidine mouthwash with boric acid (0.1%); Procedure: Chlorhexidine mouthwash with boric acid (0.5%); Procedure: Chlorhexidine mouthwash with boric acid (1%); Procedure: Chlorhexidine mouthwash with boric acid (1.5%); Procedure: Chlorhexidine mouthwash with boric acid (2%); Procedure: Chlorhexidine mouthwash with boric acid (2.5%); Procedure: Boric acid mouthwash (2%)

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Van, Turkey, 65080
    • Van Yuzuncu Yil University, Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Chlorhexidine gluconate; Chlorhexidine is one of the most commonly used medications after tooth extraction. It exhibits a wide spectrum of antiseptic, bactericidal and bacteriostatic effects.	Drug: Chlorhexidine mouthwash; After anesthesia, the horizontal incision was made with no. 15 scalpel blade and a full thickness mucoperiosteal flap was raised. In all surgical procedures, bone removal and/or tooth sectioning were performed under abundant irrigation. Following the extraction, granulation tissues were removed, and post extraction cavity was irrigated with sterile 0.9% saline solution. After the bleeding was controlled, the mucoperiosteal flap was repositioned by 3.0 silk sutures. The patients were postoperatively prescribed paracetamol (Parol® 500 mg, Atabay Chemical Industry, Istanbul, Turkey) to use when required with a maximum of 4 doses per day. Patients were instructed to maintain a soft diet, and refrain from mouth washing, brushing and flossing during the first 24 hour. They were also instructed to rinse their mouth with 15 ml of mouthwash for 30 seconds, 3 times a day, and continue until the 7th postoperative day.; Other Names: Kloroben Oral Rinse
Active Comparator: 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.	Procedure: Chlorhexidine mouthwash with boric acid (0.1%); After anesthesia, the horizontal incision was made with no. 15 scalpel blade and a full thickness mucoperiosteal flap was raised. In all surgical procedures, bone removal and/or tooth sectioning were performed under abundant irrigation. Following the extraction, granulation tissues were removed, and post extraction cavity was irrigated with sterile 0.9% saline solution. After the bleeding was controlled, the mucoperiosteal flap was repositioned by 3.0 silk sutures. The patients were postoperatively prescribed paracetamol (Parol® 500 mg, Atabay Chemical Industry, Istanbul, Turkey) to use when required with a maximum of 4 doses per day. Patients were instructed to maintain a soft diet, and refrain from mouth washing, brushing and flossing during the first 24 hour. They were also instructed to rinse their mouth with 15 ml of mouthwash for 30 seconds, 3 times a day, and continue until the 7th postoperative day.
Active Comparator: 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.	Procedure: Chlorhexidine mouthwash with boric acid (0.5%); After anesthesia, the horizontal incision was made with no. 15 scalpel blade and a full thickness mucoperiosteal flap was raised. In all surgical procedures, bone removal and/or tooth sectioning were performed under abundant irrigation. Following the extraction, granulation tissues were removed, and post extraction cavity was irrigated with sterile 0.9% saline solution. After the bleeding was controlled, the mucoperiosteal flap was repositioned by 3.0 silk sutures. The patients were postoperatively prescribed paracetamol (Parol® 500 mg, Atabay Chemical Industry, Istanbul, Turkey) to use when required with a maximum of 4 doses per day. Patients were instructed to maintain a soft diet, and refrain from mouth washing, brushing and flossing during the first 24 hour. They were also instructed to rinse their mouth with 15 ml of mouthwash for 30 seconds, 3 times a day, and continue until the 7th postoperative day.
Active Comparator: 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.	Procedure: Chlorhexidine mouthwash with boric acid (1%); After anesthesia, the horizontal incision was made with no. 15 scalpel blade and a full thickness mucoperiosteal flap was raised. In all surgical procedures, bone removal and/or tooth sectioning were performed under abundant irrigation. Following the extraction, granulation tissues were removed, and post extraction cavity was irrigated with sterile 0.9% saline solution. After the bleeding was controlled, the mucoperiosteal flap was repositioned by 3.0 silk sutures. The patients were postoperatively prescribed paracetamol (Parol® 500 mg, Atabay Chemical Industry, Istanbul, Turkey) to use when required with a maximum of 4 doses per day. Patients were instructed to maintain a soft diet, and refrain from mouth washing, brushing and flossing during the first 24 hour. They were also instructed to rinse their mouth with 15 ml of mouthwash for 30 seconds, 3 times a day, and continue until the 7th postoperative day.
Active Comparator: 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.	Procedure: Chlorhexidine mouthwash with boric acid (1.5%); After anesthesia, the horizontal incision was made with no. 15 scalpel blade and a full thickness mucoperiosteal flap was raised. In all surgical procedures, bone removal and/or tooth sectioning were performed under abundant irrigation. Following the extraction, granulation tissues were removed, and post extraction cavity was irrigated with sterile 0.9% saline solution. After the bleeding was controlled, the mucoperiosteal flap was repositioned by 3.0 silk sutures. The patients were postoperatively prescribed paracetamol (Parol® 500 mg, Atabay Chemical Industry, Istanbul, Turkey) to use when required with a maximum of 4 doses per day. Patients were instructed to maintain a soft diet, and refrain from mouth washing, brushing and flossing during the first 24 hour. They were also instructed to rinse their mouth with 15 ml of mouthwash for 30 seconds, 3 times a day, and continue until the 7th postoperative day.
Active Comparator: 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.	Procedure: Chlorhexidine mouthwash with boric acid (2%); After anesthesia, the horizontal incision was made with no. 15 scalpel blade and a full thickness mucoperiosteal flap was raised. In all surgical procedures, bone removal and/or tooth sectioning were performed under abundant irrigation. Following the extraction, granulation tissues were removed, and post extraction cavity was irrigated with sterile 0.9% saline solution. After the bleeding was controlled, the mucoperiosteal flap was repositioned by 3.0 silk sutures. The patients were postoperatively prescribed paracetamol (Parol® 500 mg, Atabay Chemical Industry, Istanbul, Turkey) to use when required with a maximum of 4 doses per day. Patients were instructed to maintain a soft diet, and refrain from mouth washing, brushing and flossing during the first 24 hour. They were also instructed to rinse their mouth with 15 ml of mouthwash for 30 seconds, 3 times a day, and continue until the 7th postoperative day.
Active Comparator: 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.	Procedure: Chlorhexidine mouthwash with boric acid (2.5%); After anesthesia, the horizontal incision was made with no. 15 scalpel blade and a full thickness mucoperiosteal flap was raised. In all surgical procedures, bone removal and/or tooth sectioning were performed under abundant irrigation. Following the extraction, granulation tissues were removed, and post extraction cavity was irrigated with sterile 0.9% saline solution. After the bleeding was controlled, the mucoperiosteal flap was repositioned by 3.0 silk sutures. The patients were postoperatively prescribed paracetamol (Parol® 500 mg, Atabay Chemical Industry, Istanbul, Turkey) to use when required with a maximum of 4 doses per day. Patients were instructed to maintain a soft diet, and refrain from mouth washing, brushing and flossing during the first 24 hour. They were also instructed to rinse their mouth with 15 ml of mouthwash for 30 seconds, 3 times a day, and continue until the 7th postoperative day.
Active Comparator: 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.	Procedure: Boric acid mouthwash (2%); After anesthesia, the horizontal incision was made with no. 15 scalpel blade and a full thickness mucoperiosteal flap was raised. In all surgical procedures, bone removal and/or tooth sectioning were performed under abundant irrigation. Following the extraction, granulation tissues were removed, and post extraction cavity was irrigated with sterile 0.9% saline solution. After the bleeding was controlled, the mucoperiosteal flap was repositioned by 3.0 silk sutures. The patients were postoperatively prescribed paracetamol (Parol® 500 mg, Atabay Chemical Industry, Istanbul, Turkey) to use when required with a maximum of 4 doses per day. Patients were instructed to maintain a soft diet, and refrain from mouth washing, brushing and flossing during the first 24 hour. They were also instructed to rinse their mouth with 15 ml of mouthwash for 30 seconds, 3 times a day, and continue until the 7th postoperative day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain	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 1st day
Postoperative Swelling	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).	Postoperatif 1st day
Postoperative Trismus	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.	Postoperative 1st day
Postoperative Pain	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 2nd day
Postoperative Pain	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 3rd day
Postoperative Swelling	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).	Postoperatif 3rd day
Postoperative Trismus	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.	Postoperative 3rd day
Postoperative Pain	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 4th day
Postoperative Pain	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 5th day
Postoperative Pain	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 6th day
Postoperative Pain	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 7th day
Postoperative Swelling	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).	Postoperatif 7th day
Postoperative Trismus	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.	Postoperative 7th day

Collaborators and Investigators

• Sponsor: Yuzuncu Yıl University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2019
• Primary Completion (Estimated): November 15, 2023
• Study Completion (Estimated): December 15, 2023

Study Registration Dates

• First Submitted: May 2, 2020
• First Submitted That Met QC Criteria: May 2, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 20, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: chlorhexidine; postoperative complications; mouthwash; boric acid; impacted tooth
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth, Impacted; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: 01.08.2018/07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No