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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] 252038 0
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 257575 0
Condition category
Condition code
Surgery 257745 257745 0 0
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] 256669 0
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] 258626 0
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] 258626 0
Pre-operative and two and seven days post-operatively.
Primary outcome [2] 258631 0
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] 258631 0
Pre-operative and two and seven days post-operatively.
Primary outcome [3] 258632 0
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] 258632 0
Pre-operative and two and seven days post-operatively.
Secondary outcome [1] 264582 0
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] 264582 0
Pre-operative and six and nine months post-operative
Secondary outcome [2] 264587 0
Pocket depth was assessed by measuring the distance from the gingiva margin distal to the second molar to the depth of the periodontal pocket at the same two points. The probe tip was inserted into the gingival sulcus parallel to the long axis of the tooth until slight resistance was met and the depth was measured.
Timepoint [2] 264587 0
Pre-operative and six and nine months post-operative
Secondary outcome [3] 264588 0
Clinical attachment loss was then calculated by the subtraction of the gingival recession from the pocket depth measurements.
Timepoint [3] 264588 0
Pre-operative and six and nine months post-operative
Secondary outcome [4] 264589 0
The amount of plaque present on the second molar tooth and the gingival inflammation distal to the second molar tooth were assessed clinically using indices described by Silness et al. (1964) and Loe et al. (1963) respectively.
Timepoint [4] 264589 0
Pre-operative and six and nine months post-operative
Secondary outcome [5] 264590 0
Participants were asked if they had suffered any sensitivity in their lower second molar tooth since the procedure.
Timepoint [5] 264590 0
Pre-operative and six and nine months post-operative
Secondary outcome [6] 264591 0
The presence/absence of dry socket/infection was clinically assessed.
Timepoint [6] 264591 0
Pre-operative and two and seven days post-operatively.

Eligibility
Key inclusion criteria
The inclusion criteria for this study included: bilateral symmetrically impacted partially erupted mandibular third molars, with no associated pathology, no medical conditions or medications that may alter wound healing potential, must be American Society of Anesthesiologists physical status classification I or II, and aged between sixteen and forty years of age.
Minimum age
16 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients were excluded from the study if there was a history of abuse of midazolam, allergy to any medications used during or after the procedure for patient management, were on long term steroid or bisphosphonate medication, pregnancy, previous or present radiotherapy to the third molar tooth region of the lower jaw, or had a bone disorder such as Paget’s disease or fibrous dysplasia that could interfere with bone healing.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants were selected from the University of Otago, Faculty of Dentistry waiting list for extraction of lower wisdom teeth which had been assessed and required removal based on clinical and radiographic grounds. Participants were randomly allocated into one of two groups using the logan envelope technique. In one group the first procedure was carried out using the envelope flap design, while with the other the pedicle design was used first. Both flap designs were then randomly allocated to either the left or right side of each participant’s lower jaw again using the logan envelope technique. The logan envelope technique involves taking two large envelopes and filling each with the same number of smaller envelopes containing equal amounts of letters. Each letter had written on it either envelope or pedicle flap in one large envelope and left or right on the other.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation was carried out also using the logan envelope technique mentioned above.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Only one surgeon carried out all the procedures and only one clinician carried out all of the pre- and post-operative examinations
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment outside Australia
Country [1] 2700 0
New Zealand
State/province [1] 2700 0
Dunedin

Funding & Sponsors
Funding source category [1] 257141 0
Charities/Societies/Foundations
Name [1] 257141 0
New Zealand Dental Research Foundation
Country [1] 257141 0
New Zealand
Funding source category [2] 257142 0
University
Name [2] 257142 0
Faculty of Dentistry, University of Otago Fuller Scholarship
Country [2] 257142 0
New Zealand
Primary sponsor type
University
Name
Faculty of Dentistry, University of Otago
Address
310 Great King st
Dunedin 9054

PO Box 647
University of Otago
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 256406 0
None
Name [1] 256406 0
Address [1] 256406 0
Country [1] 256406 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259178 0
Lower South Regional Ethics Committee of New Zealand
Ethics committee address [1] 259178 0
PO Box 5849
Dunedin 9058

c/- Ministry of Health
229 Moray Place
Dunedin 9016
Ethics committee country [1] 259178 0
New Zealand
Date submitted for ethics approval [1] 259178 0
10/06/2008
Approval date [1] 259178 0
27/03/2009
Ethics approval number [1] 259178 0
LRS/08/07/027
Ethics committee name [2] 259179 0
University of Otago Maori consultation process - Ngai Tahu Research Consultation Committes
Ethics committee address [2] 259179 0
University of Otago
364 Leith Walk
Dunedin 9016

PO Box 56
Dunedin 9054
Ethics committee country [2] 259179 0
New Zealand
Date submitted for ethics approval [2] 259179 0
29/04/2008
Approval date [2] 259179 0
01/05/2008
Ethics approval number [2] 259179 0
29/04/2008 - 32

Summary
Brief summary
A sample of patients was obtained from the waiting list at the the School of Dentistry with symmetrically impacted lower wisdom teeth. The patients will receive removal of their wisdom tooth incorporating a different gum flap (incision) design randomly assigned to each side; a conventional flap or a pedicle flap design. Post-extraction complications, including pain, swelling, delayed healing, jaw muscle spasm, gum recession and associated tooth sensitivity will be evaluated immediately after the procedure and at a subsequent review appointment. To ascertain severity of sequelae, a comparison will be made of preoperative and postoperative values and conclusions drawn from the data. It is hypothesised that a pedicle flap will reduce the risk or severity of the above mentioned post-operative complications after lower third molar removal
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31296 0
Address 31296 0
Country 31296 0
Phone 31296 0
Fax 31296 0
Email 31296 0
Contact person for public queries
Name 14543 0
Sam Goldsmith
Address 14543 0
Oral Surgery Department
Faculty of Dentistry
PO Box 647
University of Otago
Dunedin 9054
Country 14543 0
New Zealand
Phone 14543 0
+64 3 4797023
Fax 14543 0
+64 3 4797023
Email 14543 0
[email protected]
Contact person for scientific queries
Name 5471 0
Sam Goldsmith
Address 5471 0
Oral Surgery Department
Faculty of Dentistry
PO Box 647
University of Otago
Dunedin 9054
Country 5471 0
New Zealand
Phone 5471 0
+64 3 4797023
Fax 5471 0
+64 3 4797023
Email 5471 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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