Back to resultsEffect of St. John's Wort and Olive Oils on the Postoperative Complications
Primary Purpose
Impacted Third Molar Tooth
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Chlorhexidine Gluconate 0.12 % Mouthwash + benzydamine hydrochloride
St. John's wort oil
Virgin olive oil
Sponsored by
About this trial
This is an interventional treatment trial for Impacted Third Molar Tooth
Eligibility Criteria
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
Sites / Locations
- Van Yuzuncu Yil University, Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
chlorhexidine gluconate plus benzydamine hydrochloride
St. John's wort oil
Virgin olive oil
Arm Description
Chlorhexidine is one of the most commonly used medications after tooth extraction. It exhibits a wide spectrum of antiseptic, bactericidal and bacteriostatic effects. The most common side effect of chlorhexidine is oral discoloration, taste changes and allergic responses. Furthermore, it has been reported that chlorhexidine has cytotoxic effect on gingival fibroblasts, epithelial cells, neutrophils and red blood cells; also shows incremental trend in genotoxicity as the duration of usage is increased. Benzydamine hydrochloride is a nonsteroidal anti-inflammatory drug that elicits anti-inflammatory, analgesic, anesthetic and antimicrobial effects. It is often used in addition to the topical application of chlorhexidine.. However, side effects such as urticaria, erythema, pruritus, photosensitivity, bronchospasm and renal problems can be observed associated with the use of benzydamine.
St. John's Wort (Hypericum perforatum) is a European medicinal plant with a history of more than 2000 years which possessing a variety of important constituents including phloroglucinols (hyperforin and adhyperforin), naphthodianthrones (hypericin and pseudohypericin), xanthones, essential oil, biflavones (biapigenin and amentoflavone), flavonol derivatives and phenolic compounds. The important components of St. John's Wort such as hypericin and hyperforin exert anti-inflammatory, antimicrobial, anticancer effects as well as stimulating tissue growth and differentiation. Hypericin exhibits anti-inflammatory effects by inhibiting the production of interleukin-12; whereas hyperforin reveals this effect by inhibiting the mechanisms of cyclooxygenase 1, 5-lipoxygenase and prostaglandin E2. St. John's Wort oil is extracted by maceration of the hypericum herb in carrier oil, such as virgin olive oil.
The olive oil, a product extracted from the fruit of Olea europaea, exerts also antioxidant and anti-inflammatory effects due to its important contents including oleic acids, phenolic acids, secoiridoids and flavonoids. The oral application of olive oil has been shown to have protective anti-inflammatory effects and accelerated epithelial healing.
Outcomes
Primary Outcome Measures
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.
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.
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 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 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.
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.
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..
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.
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 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 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.
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.
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.
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.
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.
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.
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.
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.
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 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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04373421
Brief Title
Effect of St. John's Wort and Olive Oils on the Postoperative Complications
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
August 15, 2018 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
June 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impacted Third Molar Tooth
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
chlorhexidine gluconate plus benzydamine hydrochloride
Arm Type
Active Comparator
Arm Description
Chlorhexidine is one of the most commonly used medications after tooth extraction. It exhibits a wide spectrum of antiseptic, bactericidal and bacteriostatic effects. The most common side effect of chlorhexidine is oral discoloration, taste changes and allergic responses. Furthermore, it has been reported that chlorhexidine has cytotoxic effect on gingival fibroblasts, epithelial cells, neutrophils and red blood cells; also shows incremental trend in genotoxicity as the duration of usage is increased. Benzydamine hydrochloride is a nonsteroidal anti-inflammatory drug that elicits anti-inflammatory, analgesic, anesthetic and antimicrobial effects. It is often used in addition to the topical application of chlorhexidine.. However, side effects such as urticaria, erythema, pruritus, photosensitivity, bronchospasm and renal problems can be observed associated with the use of benzydamine.
Arm Title
St. John's wort oil
Arm Type
Active Comparator
Arm Description
St. John's Wort (Hypericum perforatum) is a European medicinal plant with a history of more than 2000 years which possessing a variety of important constituents including phloroglucinols (hyperforin and adhyperforin), naphthodianthrones (hypericin and pseudohypericin), xanthones, essential oil, biflavones (biapigenin and amentoflavone), flavonol derivatives and phenolic compounds. The important components of St. John's Wort such as hypericin and hyperforin exert anti-inflammatory, antimicrobial, anticancer effects as well as stimulating tissue growth and differentiation. Hypericin exhibits anti-inflammatory effects by inhibiting the production of interleukin-12; whereas hyperforin reveals this effect by inhibiting the mechanisms of cyclooxygenase 1, 5-lipoxygenase and prostaglandin E2. St. John's Wort oil is extracted by maceration of the hypericum herb in carrier oil, such as virgin olive oil.
Arm Title
Virgin olive oil
Arm Type
Active Comparator
Arm Description
The olive oil, a product extracted from the fruit of Olea europaea, exerts also antioxidant and anti-inflammatory effects due to its important contents including oleic acids, phenolic acids, secoiridoids and flavonoids. The oral application of olive oil has been shown to have protective anti-inflammatory effects and accelerated epithelial healing.
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine Gluconate 0.12 % Mouthwash + benzydamine hydrochloride
Other Intervention Name(s)
Kloroben Oral Rinse
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
St. John's wort oil
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
Virgin olive oil
Intervention 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.
Primary Outcome Measure Information:
Title
Postoperative Pain
Description
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.
Time Frame
Postoperatif 1st day
Title
Postoperative Jaw Function
Description
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.
Time Frame
Postoperatif 1st day
Title
Postoperative Swelling
Description
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.
Time Frame
Postoperative 1st day
Title
Postoperative Trismus
Description
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).
Time Frame
Postoperative 1st day
Title
Postoperative Pain
Description
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.
Time Frame
Postoperatif 2nd day
Title
Postoperative Jaw Function
Description
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.
Time Frame
Postoperatif 2nd day
Title
Postoperative Pain
Description
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..
Time Frame
Postoperatif 3rd day
Title
Postoperative Jaw Function
Description
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.
Time Frame
Postoperatif 3rd day
Title
Postoperative Swelling
Description
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.
Time Frame
Postoperative 3rd day
Title
Postoperative Trismus
Description
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).
Time Frame
Postoperative 3rd day
Title
Postoperative Pain
Description
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.
Time Frame
Postoperatif 4th day
Title
Postoperative Jaw Function
Description
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.
Time Frame
Postoperatif 4th day
Title
Postoperative Pain
Description
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.
Time Frame
Postoperatif 5th day
Title
Postoperative Jaw Function
Description
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.
Time Frame
Postoperatif 5th day
Title
Postoperative Pain
Description
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.
Time Frame
Postoperatif 6th day
Title
Postoperative Jaw Function
Description
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.
Time Frame
Postoperatif 6th day
Title
Postoperative Pain
Description
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.
Time Frame
Postoperatif 7th day
Title
Postoperative Jaw Function
Description
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.
Time Frame
Postoperatif 7th day
Title
Postoperative Swelling
Description
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.
Time Frame
Postoperative 7th day
Title
Postoperative Trismus
Description
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).
Time Frame
Postoperative 7th day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serap KESKIN TUNC, PhD
Organizational Affiliation
Van Yuzuncu Yil University, Faculty of Dentistry, Van, Tusba, Turkey, 65080
Official's Role
Study Chair
Facility Information:
Facility Name
Van Yuzuncu Yil University, Faculty of Dentistry
City
Van
ZIP/Postal Code
65080
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of St. John's Wort and Olive Oils on the Postoperative Complications
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