Molar, Third Clinical Trial
Official title:
Effect of Hilotherm Therapy on Post-operative Pain and Swelling Following Surgical Lower Third Molar Removal
This study evaluates the efficacy of Hilotherm therapy on the incidence of swelling and pain following the surgical removal of lower wisdom teeth. All participants will have two lower wisdom teeth removed, with the Hilotherm cooling face mask only applied to one side of the patients' face for 60 minutes post-operatively, thus the patient being their own control.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | July 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 16 Years to 60 Years |
Eligibility |
Inclusion Criteria: - any patients requiring bilateral lower third molars extracted of similar technical difficulty under general anaesthesia Exclusion Criteria: - any intra-operative complications - any post-operative complications, including infection - if the extractions end up being too dissimilar surgically - any contra-indication to the Hilotherm mask - patients with any immune system-affecting diseases - patients with allergies to pharmaceutical drugs (eg. analgesics or antibiotics) |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United Kingdom | Queen Marys Hospital, Kings College London NHS Foundation Trust | Sidcup | Kent |
Lead Sponsor | Collaborator |
---|---|
King's College Hospital NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in post-operative swelling using 3D photography analysis | Extent of swelling on the side of wisdom tooth removal with the intervention compared with the side without the intervention | Day 0 (pre/60 min post op), Days 3, 10, 24. | No |
Primary | Change in pain intensity using visual analogue scale | Self-reported pain intensity using visual analogue scale at time intervals as above, comparing the side of wisdom tooth removal with intervention vs the side of wisdom tooth removal without intervention | Day 0 (60 min post-op), Days 3, 10, 24. | No |
Secondary | Patient satisfaction | Patient satisfaction questionnaire to ask them to assess and compare side with intervention versus side without intervention. Did they feel it made a big difference to their post-operative pain and swelling, and to the speed with which they felt they could return to normal life (eg work?) | Day 24 | No |
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