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Completed

NCT Number: NCT04373421

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

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.

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Key information

Conditions

Impacted Third Molar Tooth

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Van Yuzuncu Yil University, Faculty of Dentistry

Van, 65080, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chlorhexidine Gluconate 0.12 % Mouthwash + benzydamine hydrochloride

Drug

After anesthesia, the horizontal incision was made with no. 15 scalpel blade and a full thickness mucoperiosteal flap was raised. In all surgical procedures, bone removal and/or tooth sectioning were performed under abundant irrigation. Following the extraction, granulation tissues were removed, and post extraction cavity was irrigated with sterile 0.9% saline solution. After the bleeding was controlled, the mucoperiosteal flap was repositioned by 3.0 silk sutures. The patients were postoperatively prescribed paracetamol (Parol® 500 mg, Atabay Chemical Industry, Istanbul, Turkey) to use when required with a maximum of 4 doses per day. Patients were instructed to maintain a soft diet, and refrain from mouth washing, brushing and flossing during the first 24 hour. They were also instructed to rinse their mouth with 15 ml of mouthwash for 30 seconds, 3 times a day, and continue until the 7th postoperative day.

Other names: Kloroben Oral Rinse

St. John's wort oil

Procedure

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

Procedure

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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. 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.

  7. 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..

  8. 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.

  9. 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.

  10. 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).

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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).

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
May 4, 2020
Registry last updated
Nov 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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