Koyuncu 2015.
Study characteristics | ||
Methods | Study design: prospective RCT, single‐blind, parallel Conducted in: Turkey |
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Participants | Inclusion criteria: bilateral vertically symmetrical impacted third molars on panoramic radiographs. All impacted mandibular third molars had to be in a comparable position bilaterally and carry the same degree of surgical difficulty requiring the same technique. All teeth were fully covered by mucosa and bone. All participants were non‐smokers, periodontally healthy, and well‐educated about their daily oral hygiene. Exclusion criteria: history of medical illness or medication that could influence the course of postoperative wound healing or alter wound healing after extraction. Also excluded were patients who had any pathological lesion in the area of the impacted third molar. The periods between the incision and insertion of the last suture were recorded, and if the operating time differed by more than 5 minutes between the 2 sides, the patient was withdrawn from the study. Age: 18 to 29 years Number randomised: 40 Number evaluated: 40 |
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Interventions | Effect of tube drainage versus conventional suturing on postoperative discomfort after extraction Group experimental: a tube drain (n = 40 teeth): an infant feeding tube 3 cm long and 2.67 mm in diameter (8 Ch) (Bıc¸akcılar, Istanbul, Turkey) was inserted in the buccal incision line between the first and second molar. The tube drain was sutured to the vestibular mucosa to prevent it from coming out or becoming lost in the wound. Group B control: no drain (n = 40): a 3‐cornered mucoperiosteal flap was raised to expose the third molar. Bone was removed under constant irrigation with sterile 0.9% saline on the occlusal and buccal aspect of the third molar with rotating instruments of diminishing size. After extraction, potential nests of the dental follicle were removed. Primary wound closure with atraumatic silk sutures without tension (Medico Co. Ltd, China) was used on the side that had no drain. |
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Outcomes | Pain (VAS) from zero (no pain) to 10 (worst pain imaginable) daily for 7 days Degree of swelling (mm) at days 2 and 7 Maximum mouth opening at days 2 and 7 A quality of life questionnaire was used; all participants returned the questionnaires on day 7 |
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Notes | Sample size calculation: not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "groups by random selection in a cross‐over pattern. The trial was randomised, prospective, and single‐blind." Comment: method of randomisation not described |
Allocation concealment (selection bias) | Unclear risk | Comment: concealment methods not described |
Blinding (performance bias and detection bias) patient | High risk | Comment: "a single blinded study". It is unlikely that participants could be blinded with this study design. |
Blinding (performance bias and detection bias) assessor | Low risk | Quote: "The surgeon who had operated on the patients was not involved in either the preoperative or the postoperative assessment" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcomes reported for all participants. |
Selective reporting (reporting bias) | Low risk | All outcomes reported. |
Other bias | Unclear risk | Carry‐over effect not evaluated. |