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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00017024
Enrollment
40
Registered
2019-04-02
Start date
2017-12-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K07.3

Interventions

Group 1: Inserting a drain on one operation site in the lower jaw before closing the wound Group 2: On the other operation site in the lower jaw the wound is closed without inserting a drain

Sponsors

Uniklinik RWTH Aachen,Klinik für Mund-Kiefer- und Gesichtschirurgie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

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).

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Germany

Contacts

Public ContactMarie Sophie Katz

Uniklinik RWTH Aachen,Klinik für Mund-Kiefer- und Gesichtschirurgie

mkatz@ukaachen.de0241-8088231

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026