Impacted Third Molar ToothPhase 4NCT04373421
Effect of St. John's Wort and Olive Oils on the Postoperative Complications
A Phase 4 study testing Chlorhexidine Gluconate 0.12 % Mouthwash + benzydamine hydrochloride, St. John's wort oil and Virgin olive oil in people with Impacted Third Molar Tooth, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Impacted Third Molar Tooth
- What is being tested?
- Chlorhexidine Gluconate 0.12 % Mouthwash + benzydamine hydrochloride, St. John's wort oil and Virgin olive oil
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2018to 1 Jun 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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,
Who cannot join
- Patients with smoking habits, drug abuse, history of pericoronitis associated with the lower third molar
- not regularly coming to the controls
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van Yuzuncu Yil University, Faculty of Dentistry
Van, 65080
About this study
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
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.
- Conditions
- Impacted Third Molar Tooth
- Being tested
- Chlorhexidine Gluconate 0.12 % Mouthwash + benzydamine hydrochloride, St. John's wort oil, Virgin olive oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine Gluconate 0.12 % Mouthwash + benzydamine hydrochlorideDrug
Also called Kloroben Oral Rinse
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.
St. John's wort oilProcedure or surgery
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 oilProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| chlorhexidine gluconate plus benzydamine hydrochloride | Active comparator | 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. Receives: Drug: Chlorhexidine Gluconate 0.12 % Mouthwash + benzydamine hydrochloride |
| St. John's wort oil | Active comparator | 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. Receives: Procedure: St. John's wort oil |
| Virgin olive oil | Active comparator | 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. Receives: Procedure: Virgin olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperatif 1st day
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.
Measured: Postoperatif 1st day
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.
Measured: Postoperative 1st day
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).
Measured: Postoperative 1st day
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.
Measured: Postoperatif 2nd day
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.
Measured: Postoperatif 2nd day
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..
Measured: Postoperatif 3rd day
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.
Measured: Postoperatif 3rd day
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.
Measured: Postoperative 3rd day
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).
Measured: Postoperative 3rd day
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.
Measured: Postoperatif 4th day
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.
Measured: Postoperatif 4th day
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.
Measured: Postoperatif 5th day
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.
Measured: Postoperatif 5th day
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.
Measured: Postoperatif 6th day
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.
Measured: Postoperatif 6th day
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.
Measured: Postoperatif 7th day
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.
Measured: Postoperatif 7th day
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.
Measured: Postoperative 7th day
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).
Measured: Postoperative 7th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start15 Aug 2018
- Primary completion31 Mar 2019
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Impacted Third Molar ToothStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, levent Cigerim, Yuzuncu Yil University
- Investigators
- Serap KESKIN TUNC, PhD, Study chair, Van Yuzuncu Yil University, Faculty of Dentistry, Van, Tusba, Turkey, 65080
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373421
- Sponsor's protocol ID
- 01.08.2018/08
- Status last verified
- Oct 2021
- First submitted
- 29 Apr 2020
- Last updated
- 1 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04373421
- Acronym / sponsor ID
- 01.08.2018/08
- Conditions
- Impacted Third Molar Tooth
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 4 May 2020 (actual)
- Results
- Posted 1 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| chlorhexidine gluconate plus benzydamine hydrochloride | Active comparator | Drug: Chlorhexidine Gluconate 0.12 % Mouthwash + benzydamine hydrochlorideChlorhexidine 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 oil | Active comparator | Procedure: St. John's wort oilSt. 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. |
| Virgin olive oil | Active comparator | Procedure: Virgin olive oilThe 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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,
Key exclusion criteria (2 listed)
- Patients with smoking habits, drug abuse, history of pericoronitis associated with the lower third molar
- not regularly coming to the controls
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorhexidine Gluconate 0.12 % Mouthwash + benzydamine hydrochlorideAlso: Kloroben Oral RinseAfter 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. | Drug | chlorhexidine gluconate plus benzydamine hydrochloride |
| St. John's wort oilAfter 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 or surgery | St. John's wort oil |
| Virgin olive oilAfter 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 or surgery | Virgin olive oil |
Primary outcome
Postoperative Pain
Time frame: Postoperatif 1st day
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
Time frame: Postoperatif 1st day
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
Time frame: Postoperative 1st day
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
Time frame: Postoperative 1st day
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
Time frame: Postoperatif 2nd day
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
Time frame: Postoperatif 2nd day
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
Time frame: Postoperatif 3rd day
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
Time frame: Postoperatif 3rd day
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
Time frame: Postoperative 3rd day
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
Time frame: Postoperative 3rd day
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
Time frame: Postoperatif 4th day
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
Time frame: Postoperatif 4th day
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
Time frame: Postoperatif 5th day
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
Time frame: Postoperatif 5th day
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
Time frame: Postoperatif 6th day
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
Time frame: Postoperatif 6th day
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
Time frame: Postoperatif 7th day
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
Time frame: Postoperatif 7th day
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
Time frame: Postoperative 7th day
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
Time frame: Postoperative 7th day
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serap KESKIN TUNC, PhD study chair
Van Yuzuncu Yil University, Faculty of Dentistry, Van, Tusba, Turkey, 65080
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chlorhexidine Gluconate 0.12 % Mouthwash + benzydamine hydrochloride, St. John's wort oil and Virgin olive oil in people with Impacted Third Molar Tooth, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain (time frame: Postoperatif 1st day). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.