Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-29 @ 2:52 AM
Study NCT ID:
NCT04376268
Status:
UNKNOWN
Last Update Posted:
2023-08-22
First Post:
2020-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Efficacy of Boric Acid Mouthwashes in Different Concentrations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D014095', 'term': 'Tooth, Impacted'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C032688', 'term': 'boric acid'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-20', 'studyFirstSubmitDate': '2020-05-02', 'studyFirstSubmitQcDate': '2020-05-02', 'lastUpdatePostDateStruct': {'date': '2023-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Pain', 'timeFrame': 'Postoperative 1st day', 'description': '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.'}, {'measure': 'Postoperative Swelling', 'timeFrame': 'Postoperatif 1st day', 'description': '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).'}, {'measure': 'Postoperative Trismus', 'timeFrame': 'Postoperative 1st day', 'description': '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.'}, {'measure': 'Postoperative Pain', 'timeFrame': 'Postoperative 2nd day', 'description': '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.'}, {'measure': 'Postoperative Pain', 'timeFrame': 'Postoperative 3rd day', 'description': '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.'}, {'measure': 'Postoperative Swelling', 'timeFrame': 'Postoperatif 3rd day', 'description': '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).'}, {'measure': 'Postoperative Trismus', 'timeFrame': 'Postoperative 3rd day', 'description': '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.'}, {'measure': 'Postoperative Pain', 'timeFrame': 'Postoperative 4th day', 'description': '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.'}, {'measure': 'Postoperative Pain', 'timeFrame': 'Postoperative 5th day', 'description': '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.'}, {'measure': 'Postoperative Pain', 'timeFrame': 'Postoperative 6th day', 'description': '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.'}, {'measure': 'Postoperative Pain', 'timeFrame': 'Postoperative 7th day', 'description': '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.'}, {'measure': 'Postoperative Swelling', 'timeFrame': 'Postoperatif 7th day', 'description': '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).'}, {'measure': 'Postoperative Trismus', 'timeFrame': 'Postoperative 7th day', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postoperative complications', 'impacted tooth', 'mouthwash', 'boric acid', 'chlorhexidine'], 'conditions': ['Impacted Third Molar Tooth']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* absence of any systemic disease\n* having impacted mandibular third molar teeth in a similar position\n* absence of allergy to any of the drugs used in the study,\n* absence of pregnancy/lactating state,\n* no history of any medication use during at least 2 week before the operation.\n\nExclusion Criteria:\n\n* not regularly coming to the controls,\n* not using their medicines regularly\n* using any additional medication that may affect the outcome of the study'}, 'identificationModule': {'nctId': 'NCT04376268', 'briefTitle': 'Comparison of the Efficacy of Boric Acid Mouthwashes in Different Concentrations', 'organization': {'class': 'OTHER', 'fullName': 'Yuzuncu Yil University'}, 'officialTitle': 'Comparison of the Efficacy of Boric Acid Mouthwashes in Different Concentrations in the Lower Third Molar Surgery in the Postoperative Period', 'orgStudyIdInfo': {'id': '01.08.2018/07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Chlorhexidine gluconate', 'description': 'Chlorhexidine is one of the most commonly used medications after tooth extraction. It exhibits a wide spectrum of antiseptic, bactericidal and bacteriostatic effects.', 'interventionNames': ['Drug: Chlorhexidine mouthwash']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chlorhexidine mouthwash with boric acid (0.1%)', 'description': '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.', 'interventionNames': ['Procedure: Chlorhexidine mouthwash with boric acid (0.1%)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chlorhexidine mouthwash with boric acid (0.5%)', 'description': '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.', 'interventionNames': ['Procedure: Chlorhexidine mouthwash with boric acid (0.5%)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chlorhexidine mouthwash with boric acid (1%)', 'description': '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.', 'interventionNames': ['Procedure: Chlorhexidine mouthwash with boric acid (1%)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chlorhexidine mouthwash with boric acid (1.5%)', 'description': '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.', 'interventionNames': ['Procedure: Chlorhexidine mouthwash with boric acid (1.5%)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chlorhexidine mouthwash with boric acid (2%)', 'description': '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.', 'interventionNames': ['Procedure: Chlorhexidine mouthwash with boric acid (2%)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chlorhexidine mouthwash with boric acid (2.5%)', 'description': '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.', 'interventionNames': ['Procedure: Chlorhexidine mouthwash with boric acid (2.5%)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Boric acid mouthwash (2%)', 'description': '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.', 'interventionNames': ['Procedure: Boric acid mouthwash (2%)']}], 'interventions': [{'name': 'Chlorhexidine mouthwash', 'type': 'DRUG', 'otherNames': ['Kloroben Oral Rinse'], 'description': '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.', 'armGroupLabels': ['Chlorhexidine gluconate']}, {'name': 'Chlorhexidine mouthwash with boric acid (0.1%)', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Chlorhexidine mouthwash with boric acid (0.1%)']}, {'name': 'Chlorhexidine mouthwash with boric acid (0.5%)', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Chlorhexidine mouthwash with boric acid (0.5%)']}, {'name': 'Chlorhexidine mouthwash with boric acid (1%)', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Chlorhexidine mouthwash with boric acid (1%)']}, {'name': 'Chlorhexidine mouthwash with boric acid (1.5%)', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Chlorhexidine mouthwash with boric acid (1.5%)']}, {'name': 'Chlorhexidine mouthwash with boric acid (2%)', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Chlorhexidine mouthwash with boric acid (2%)']}, {'name': 'Chlorhexidine mouthwash with boric acid (2.5%)', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Chlorhexidine mouthwash with boric acid (2.5%)']}, {'name': 'Boric acid mouthwash (2%)', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Boric acid mouthwash (2%)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65080', 'city': 'Van', 'country': 'Turkey (Türkiye)', 'facility': 'Van Yuzuncu Yil University, Faculty of Dentistry', 'geoPoint': {'lat': 38.49457, 'lon': 43.38323}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuzuncu Yil University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Oral and Maxillofacial Surgery Department', 'investigatorFullName': 'levent Cigerim', 'investigatorAffiliation': 'Yuzuncu Yil University'}}}}