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Trial registered on ANZCTR

Registration number

ACTRN12610000500055

Ethics application status

Approved

Date submitted

16/06/2010

Date registered

17/06/2010

Date last updated

17/06/2010

Type of registration

Retrospectively registered

Titles & IDs

Public title

Influence of a pedicle flap design on post-operative sequelae after lower wisdom tooth removal

Scientific title

Influence of a pedicle mucoperiosteal flap design on pain, swelling, trismus, alveolar osteitis (dry socket), infection, gingival recession, periodontal pocketing and attachment loss after lower third molar removal

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1115-4965

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Post-operative complications after lower third molar removal

Condition category

Condition code

Surgery

Surgical techniques

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A mucoperiosteal flap often needs to be raised to remove impacted lower third molar teeth. The intervention involves the use of a pedicle flap design to raise the mucoperiosteum for lower third molar removal. The pedicle flap is used on one randomly assigned side of the patients lower jaw for this procedure, then the control flap is used on the other side around three weeks later, or vice versa. The order the flap designs are used in is also randomly assigned. The pedicle flap design involves an incision placed in the buccal gingival sulcus from the mesio-buccal line angle of the first molar to the most distal visible aspect of the third molar. Distal to the third molar the incision is extended approximately 1cm and curved towards the buccal sulcus to allow for rotation of the flap and primary closure over sound bone. Prior to closure the gingival papilla distal to the second molar is removed and the apex of the pedicle de-epithelialised. A lingual flap is raised in the subperiosteal plane and the lingual nerve protected using a Howarth retractor. A round surgical bur and copious irrigation was used to remove bone superior, distal and buccal to the crown of the third molar tooth. A fissure bur was used to section the tooth if required. The tooth is then elevated and delivered and the dental follicle removed. Sterile saline irrigation of the socket was carried out to remove debris. Interrupted and horizontal mattress sutures (3-0 polyglactin 910; Undyed Vicryl Rapide; Ethicon, Somerville, New Jersey, USA) are placed to stabilize the flap and close the extraction site to the desired degree. Each operation takes around 20 minutes. The participants are then followed up two and seven days after the procedure and again at six and nine months post-operatively.

Intervention code [1]

Treatment: Surgery

Comparator / control treatment

The comparator involves the use of the conventional envelope flap design to raise the mucoperiosteum for lower third molar removal. The conventional envelope flap is used on one randomly assigned side of the patients lower jaw for this procedure, then the test flap is used on the other side around three weeks later, or vice versa. The order the flap designs are used in is also randomly assigned. The conventional envelope flap design involves an incision placed in the buccal gingival sulcus from the mesio-buccal line angle of the first molar to the most distal visible aspect of the third molar. A releaving incision is then made extended up the external oblique ridge. A lingual flap is raised in the subperiosteal plane and the lingual nerve protected using a Howarth retractor. A round surgical bur and copious irrigation was used to remove bone superior, distal and buccal to the crown of the third molar tooth. A fissure bur was used to section the tooth if required. The tooth is then elevated and delivered and the dental follicle removed. Sterile saline irrigation of the socket was carried out to remove debris. Interrupted and horizontal mattress sutures (3-0 polyglactin 910; Undyed Vicryl Rapide; Ethicon, Somerville, New Jersey, USA) are placed to stabilize the flap and close the extraction site to the desired degree. Each operation takes around 20 minutes. The participants are then followed up two and seven days after the procedure and again at six and nine months post-operatively.

Control group

Active

Outcomes

Primary outcome [1]

Pain levels were evaluated by asking the patient to mark on a visual analogue scale the level of pain they were experiencing both at rest and on maximal mouth opening. They were also asked to record the amount of each of the prescribed analgesics they used.

Timepoint [1]

Pre-operative and two and seven days post-operatively.

Primary outcome [2]

Oro-facial swelling was assessed subjectively by asking participants to look into a mirror and mark on a separate visual analogue scale the level of facial swelling they felt was present.

Timepoint [2]

Pre-operative and two and seven days post-operatively.

Primary outcome [3]

Trismus was assessed by measuring the maximal interincisal distance i.e. the distance between the mesio-incisal edges of the maxillary and mandibular right central incisor teeth during maximal mouth opening with a standard ruler in millimeters.

Timepoint [3]

Pre-operative and two and seven days post-operatively.

Secondary outcome [1]

Gingival recession was evaluated by measuring the distance from the gingiva margin distal to the second molar to the cemento-enamel junction at the distobuccal and distolingual surfaces of the second molar tooth to the nearest millimeter using a periodontal probe.

Timepoint [1]