Effect of St. John's Wort and Olive Oils on the Postoperative Complications

Impacted Third Molar Tooth Clinical Trial

Official title:

Effect of St. John's Wort Oil and Olive Oil on the Postoperative Complications After Impacted Third Molar Surgery: Randomized, Double-blind Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04373421
• Other study ID #: 01.08.2018/08
• Status: Completed
• Phase: Phase 4
• Start date: August 15, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: October 2021
• Source: Yuzuncu Yil University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, to preclude the adverse effects of these chemical agents, there has been a search for plant-derived alternatives with anti-inflammatory, antibacterial and analgesic properties as part of the oral care routine following surgical removal of impacted third molars. However, there is no study investigating the comparison of different essential oils in the literature. Thus, this multicenter study was aimed to evaluate the effects of St. John's wort oil and virgin olive oil on the postoperative complications and compared with chlorhexidine gluconate plus benzydamine hydrochloride mouthwash after the removal of impacted wisdom teeth.This study was aimed to evaluate the effects of St. John's wort oil, virgin olive oil, and chlorhexidine gluconate plus benzydamine hydrochloride on the postoperative complications after the removal of impacted wisdom teeth.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 1, 2020
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• be 18-40 years old
• has unilateral mandibular impacted third molars with similar angulation position according to Winter's classification (mesio-angular) and similar impaction degree according to Pell & Gregory's classification (class II, Level B).
• absence of any systemic disease
• absence of pregnancy/lactating state,

Exclusion Criteria:

• Patients with smoking habits, drug abuse, history of pericoronitis associated with the lower third molar
• not regularly coming to the controls

Related Conditions & MeSH terms

• Impacted Third Molar Tooth
• Postoperative Complications
• Tooth, Impacted

Intervention

Drug:
• Chlorhexidine Gluconate 0.12 % Mouthwash + benzydamine hydrochloride
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.

Procedure:
• St. John's wort oil
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.
• Virgin olive oil
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.

Locations

Country	Name	City	State
Turkey	Van Yuzuncu Yil University, Faculty of Dentistry	Van

Sponsors (1)

Lead Sponsor	Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Pain	To record the level of pain, patients were instructed to rate it on a 100-mm visual analog scale (VAS) was used wherein 0 indicated no pain and 100 indicated the worst pain imaginable.	Postoperatif 1st day
Primary	Postoperative Jaw Function	For the assessment of difficulty during jaw function, patients were asked to rate it on a 100-mm VAS, wherein 0 indicated no limitation and 100 indicated severe limitation.	Postoperatif 1st day
Primary	Postoperative Swelling	Facial swelling was assessed using a thread and millimeter ruler and averaged the following five measurements: Distance I (from the angle of the mandible to labial commissure); Distance II (from the angle of the mandible to the nasal border); Distance III (from the angle of the mandible to the external corner of the eye); Distance IV (from the angle of the mandible to tragus) and Distance V (from the angle of the mandible to soft pogonion). For evaluation of changes in the abovementioned distances during the postoperative period, the percentage of facial swelling was calculated by subtracting the preoperative measurements from the postoperative measurements then divided by the preoperative measurements and multiplied by 100.	Postoperative 1st day
Primary	Postoperative Trismus	For evaluation of trismus, the percentage of difference in maximum mouth opening during the postoperative period (B) was calculated by subtracting the preoperative measurement (A) from the postoperative measurement then dividing by the preoperative measurement (A) and multiplying by 100 (percentage of difference = [B - A]/B × 100).	Postoperative 1st day
Primary	Postoperative Pain	To record the level of pain, patients were instructed to rate it on a 100-mm visual analog scales (VAS) was used wherein 0 indicated no pain and 100 indicated the worst pain imaginable.	Postoperatif 2nd day
Primary	Postoperative Jaw Function	For the assessment of difficulty during jaw function, patients were asked to rate it on a 100-mm VAS, wherein 0 indicated no limitation and 100 indicated severe limitation.	Postoperatif 2nd day
Primary	Postoperative Pain	To record the level of pain, patients were instructed to rate it on a 100-mm visual analog scales (VAS) was used wherein 0 indicated no pain and 100 indicated the worst pain imaginable..	Postoperatif 3rd day
Primary	Postoperative Jaw Function	For the assessment of difficulty during jaw function, patients were asked to rate it on a 100-mm VAS, wherein 0 indicated no limitation and 100 indicated severe limitation.	Postoperatif 3rd day
Primary	Postoperative Swelling	Facial swelling was assessed using a thread and millimeter ruler and averaged the following five measurements: Distance I (from the angle of the mandible to labial commissure); Distance II (from the angle of the mandible to the nasal border); Distance III (from the angle of the mandible to the external corner of the eye); Distance IV (from the angle of the mandible to tragus) and Distance V (from the angle of the mandible to soft pogonion). For evaluation of changes in the abovementioned distances during the postoperative period, the percentage of facial swelling was calculated by subtracting the preoperative measurements from the postoperative measurements then divided by the preoperative measurements and multiplied by 100.	Postoperative 3rd day
Primary	Postoperative Trismus	For evaluation of trismus, the percentage of difference in maximum mouth opening during the postoperative period (B) was calculated by subtracting the preoperative measurement (A) from the postoperative measurement then dividing by the preoperative measurement (A) and multiplying by 100 (percentage of difference = [B - A]/B × 100).	Postoperative 3rd day
Primary	Postoperative Pain	To record the level of pain, patients were instructed to rate it on a 100-mm visual analog scales (VAS) was used wherein 0 indicated no pain and 100 indicated the worst pain imaginable.	Postoperatif 4th day
Primary	Postoperative Jaw Function	For the assessment of difficulty during jaw function, patients were asked to rate it on a 100-mm VAS, wherein 0 indicated no limitation and 100 indicated severe limitation.	Postoperatif 4th day
Primary	Postoperative Pain	To record the level of pain, patients were instructed to rate it on a 100-mm visual analog scales (VAS) was used wherein 0 indicated no pain and 100 indicated the worst pain imaginable.	Postoperatif 5th day
Primary	Postoperative Jaw Function	For the assessment of difficulty during jaw function, patients were asked to rate it on a 100-mm VAS, wherein 0 indicated no limitation and 100 indicated severe limitation.	Postoperatif 5th day
Primary	Postoperative Pain	To record the level of pain, patients were instructed to rate it on a 100-mm visual analog scales (VAS) was used wherein 0 indicated no pain and 100 indicated the worst pain imaginable.	Postoperatif 6th day
Primary	Postoperative Jaw Function	For the assessment of difficulty during jaw function, patients were asked to rate it on a 100-mm VAS, wherein 0 indicated no limitation and 100 indicated severe limitation.	Postoperatif 6th day
Primary	Postoperative Pain	To record the level of pain, patients were instructed to rate it on a 100-mm visual analog scales (VAS) was used wherein 0 indicated no pain and 100 indicated the worst pain imaginable.	Postoperatif 7th day
Primary	Postoperative Jaw Function	For the assessment of difficulty during jaw function, patients were asked to rate it on a 100-mm VAS, wherein 0 indicated no limitation and 100 indicated severe limitation.	Postoperatif 7th day
Primary	Postoperative Swelling	Facial swelling was assessed using a thread and millimeter ruler and averaged the following five measurements: Distance I (from the angle of the mandible to labial commissure); Distance II (from the angle of the mandible to the nasal border); Distance III (from the angle of the mandible to the external corner of the eye); Distance IV (from the angle of the mandible to tragus) and Distance V (from the angle of the mandible to soft pogonion). For evaluation of changes in the abovementioned distances during the postoperative period, the percentage of facial swelling was calculated by subtracting the preoperative measurements from the postoperative measurements then divided by the preoperative measurements and multiplied by 100.	Postoperative 7th day
Primary	Postoperative Trismus	For evaluation of trismus, the percentage of difference in maximum mouth opening during the postoperative period (B) was calculated by subtracting the preoperative measurement (A) from the postoperative measurement then dividing by the preoperative measurement (A) and multiplying by 100 (percentage of difference = [B - A]/B × 100).	Postoperative 7th day