Trial document





This trial has been registered retrospectively.
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  DRKS00017024

Trial Description

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Title

Effects of a drain on postoperative complications after surgical removal of impacted wisdomteeth – A randomized single-blinded clinical trial

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In a randomized, single-blinded study, we want to investigate whether it is objectively possible to achieve less postoperative complications such as swelling, pain or restricted mouth opening by inserting a rubber drain after surgical wisdom tooth removal. The purpose of this study is to objectively assess the influence of a rubber drain on postoperative discomfort and complications. It is to be clarified whether the use of drainage can reduce pain, mouth opening restrictions and the appearance of swelling.

In the study, the lower wisdomteeth of participants are extracted as usual in two surgical procedures, each at least 30 days apart, to ensure chewing on the non-operated side and a complete rehabilitation after the initial surgery.
In one of the two procedures a rubber drain is inserted after closure into the extraction socket, in the other procedure the wound is completely closed with sutures. Both methods represent established methods of wound treatment used in our clinic and beyond.
The decision, in which of the two mandibular extraction sockets the drain is inserted is made by a computer program. This program works like a random number generator and outputs either a 1 or a 0. All patients who receive a 1 receive the insole of the drain in the lower jaw on the right side, the patients who receive a 0 will receive it on the left side. It is not possible for the doctors involved in the study to influence on which side of the mandible the drainage is inserted.

During the pre- and postoperative appointments, 3D-imagary is recorded of the face of the study participants. These 3D-images are captured with an optical scanner. There is no contact with the scanner and it does not release harmful X-rays. The 3D-image is created using phase-measuring triangulation. This method leverages a technology where the object to be scanned is illuminated from one direction and the light rays are picked up from another by the means of a camera. Two camera lenses are used as part of this process. The distance between the two cameras installed in the device is known. The recording determines the angle between the object to be recorded and the connection line between the two cameras. Consequently, the distance to the object can be calculated by different mathematical formulas. This makes it possible to assign each pixel a dedicated value in a three-dimensional space. These 3D-images will also be created of patients who are not taking part in this study and are undertaking other types of oral or maxillo-facial surgery.
The superimposition of the 3D-images allows the dimension of the soft tissues of the face to be displayed and measured prior to the operation, and the exact extent of an occurrence of swelling to be calculated after the end of the operation within the scope of the control appointments.
In both surgical procedures the patient will be interviewed prior, as well as on the two usual follow-up appointments on the third and tenth day after the procedure shortly about his pain or discomfort. The mouth opening range will be measured and the Facescan performed as described above.

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Brief Summary in Scientific Language

In a randomized, single-blind split-mouth study we will investigate whether it is objectively possible to achieve less postoperative complications such as swelling, pain or restricted mouth opening by inserting a rubber drain after surgical wisdom tooth removal.
Surgical wisdomtooth removal is a routine oral surgical procedure, but is still often associated with postoperative pain, swelling, mouth opening restrictions, and wound healing disorders or infections. Postoperative discomfort, especially after removing the wisdom teeth in the lower jaw, significantly affects the rehabilitation and well-being of patients after the procedure.

The treatment of the extraction sockets after the osteotomy of the lower wisdomteeth, represents a controversial debate, with therapeutic approaches ranging from the primary or secondary closing of the wound to the insertion of various types of drains (tubes, rubber drains or gauze strips).
Postoperative complications such as swelling and trismus can be documented both subjectively by the patient and objectively using different methods of measurement. While postoperative pain is assessed in most studies using a Visual Analogue Scale (VAS), in addition to the subject's subjective assessment of the swelling itself, there are analogous procedures such as measuring facial anatomical features and landmarks, applying a facebow, and photo documentation, all of which are associated with a certain inaccuracy of measurement and usually lack objectivity. When examining the question of whether the insertion of a drainage minimizes patient discomfort, the precise and objective measurement of postoperative swelling should therefore play a significant role.
For this purpose, 40 patients with bilaterally symmetrical and retained lower wisdomteeth are examined before and after surgical wisdom tooth removal in a randomized split-mouth study. Each patient undergoes two procedures so the wound healing in the primary surgical site can be completed before removing the wisdom teeth on the contralateral side. The interventions must therefore be at least 30 days apart. During the initial procedure, a random assignment tool determines whether the wound on the operated side is drained or primarily closed. In the subsequent intervention on the other side, the opposite procedure is used later.
Several prospective randomized studies involving 40 or fewer study participants (Manoj Chaudhary et al., Aydintug YS et al., Refo'a Y et al., Sa─člam AA et al., Rakprasitkul S1, Pairuchevej V et al., Kirk DG et al; also bibliography) have been able to show significant but mutually contradictory results regarding the different methods of wound closure after wisdom tooth surgery. Therefore, there is currently also a coexistence of the two wound closure procedures in our clinic. Since none of the previous studies includes an objectifiable measurement of swelling with 3D images, this study is intended to compare the two methods using a more sound and objective evaluation method (facescan).
For patients who are not taking part in the described study, the surgeon decides on the basis of personal preference, whether to insert a drain or to completely suture the wound. Both are established methods for surgical wisdom tooth removal and both are used in our clinic.
All patients undergo a preoperative measurement of the mouth opening and a three-dimensional visualization of the face using an optical facial scanner (Face Scan 3D-Shape®, Erlangen, Germany). The sensor uses phase-measuring triangulation and does not require tissue contact or ionizing radiation. It represents an established method in oral and maxillofacial surgery.
Postoperatively, on the third and tenth day, clinical controls are performed, with the drain being removed on the third day and the sutures on the tenth. As part of the two follow-up visits, a new face scan is performed, the mouth opening is measured, and patients are also asked about the pain on a visual analogue scale of 0-10. Based on the preoperative as well as the two postoperative face scans, the exact extent of the swelling and its evolution can now be determined. Subsequently, pain, trismus, swelling and postoperative complications (bleeding, alveolitis) between the operated side with the drain and the side on which a primary wound closure occurred are compared and evaluated.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

All relevant data are going to be published in this study.

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Organizational Data

  •   DRKS00017024
  •   2019/04/02
  •   [---]*
  •   yes
  •   Approved
  •   EK 240/17, Ethik-Kommission an der Medizinischen Fakultät der RWTH Aachen
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Secondary IDs

  •   U1111-1230-5819 
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Health Condition or Problem studied

  •   K07.3 -  Anomalies of tooth position
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Interventions/Observational Groups

  •   Inserting a drain on one operation site in the lower jaw before closing the wound
  •   On the other operation site in the lower jaw the wound is closed without inserting a drain
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Other
  •   Treatment
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

The purpose of this study is to objectively assess the influence of a rubber drain on postoperative discomfort and complications. It is to be clarified whether the use of drainage can reduce pain, mouth opening restrictions and the appearance of swelling.
In the study, the lower wisdomteeth of 40 participants are extracted as usual in two surgical procedures, each at least 30 days apart, to ensure chewing on the non-operated side and a complete rehabilitation after the initial surgery.
In one of the two procedures a rubber drain is inserted after closure into the extraction socket, in the other procedure the wound is completely closed with sutures.
During the pre- and postoperative appointments, 3D-imagary is recorded of the face of the study participants. These 3D-images are captured with an optical scanner. There is no contact with the scanner and it does not release harmful X-rays.
The superimposition of the 3D-images allows the dimension of the soft tissues of the face to be displayed and measured prior to the operation, and the exact extent of an occurrence of swelling to be calculated after the end of the operation within the scope of the control appointments.
In both surgical procedures the patient will be interviewed prior, as well as on the two usual follow-up appointments on the third and tenth day after the procedure shortly about his pain or discomfort. The mouth opening range will be measured and the Facescan performed as described above.

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Secondary Outcome

After the completed operations and follow-up appointments of the 40 study participants, the evolution of swelling, mouth opening and pain is evaluated and assessed whether the insertion of a rubber drainage had a positive effect on swelling, pain or trismus.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/12/01
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   45   Years
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Additional Inclusion Criteria

The study will involve 40 individuals aged 18-45 who have to undergo surgical wisdom tooth removal. The lower wisdom teeth have to be symmetrical impacted on both sides of the mandible (if the upper wisdom teeth are going to be removed simultaneously, they must also be symmetrical in a side-by-side comparison).

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Exclusion Criteria

The following patients are excluded from study participation: Patients under the age of 18 or over 45 years old at the time of the first examination; patients, who are suffering from systemic diseases or blood clotting disorders; patients, who are pregnant; patients, that smoke more than 5 cigarettes daily and patients who take oral anticoagulants (medicines that affect blood clotting), cortisone or antihypertensive drugs.

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Addresses

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Sources of Monetary or Material Support

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    • Uniklinik RWTH Aachen,Klinik für Mund-Kiefer- und Gesichtschirurgie
    • Mr.  PD Dr. med. Dr. med. dent.  Ali  Modabber 
    • Pauwelsstraße 30
    • 52074  Aachen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2020/01/27
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.