Pain Relief Caused by Placing Orthodontic Separators Clinical Trial
Official title:
Effect of a Double Dose of Photobiomodulaton Therapy on Orthodonthic Pain Caused by Elastomeric Separators
Verified date | August 2020 |
Source | University Hospital Rijeka |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
It has been reported that 90% of the patients experience pain during orthodontic treat-ment.
The purpose of this study was to compare the effect of a double dose of photobio-modulation
(PBM) therapy on pain perception in patients having fixed appliance treat-ment.
Twenty-two patients were recruited to participate in this single-blinded, place-bo-controlled
study. Four elastomeric separators were placed, mesially and distally to the upper first
molar on each side. The right side of the upper jaw was treated with low-power diode laser,
and the left side was a placebo, same treatment with laser switched off. Two doses of PBM
therapy (660nm, 90mW) were delivered 24 hours apart. The par-ticipants filled out the
questionnaire immediately after the placement of separators and before 1st laser treatment
(TO), 12 hours (T1), 24 hours (T2), 2 days (T3) and 3 days after the 1st treatment (T4). At
each evaluation period, the degree of pain was scored twice, one for each side.
Status | Completed |
Enrollment | 22 |
Est. completion date | July 1, 2020 |
Est. primary completion date | June 20, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 19 Years |
Eligibility |
Inclusion Criteria: -patients aged between 12-19 years referred for orthodontic treatment, no previous orthodontic treatment, good general health , permanent dentition including second molars erupted, intact first maxillary permanent molars, good interproximal contacts on all maxillary first permanent molars, healty periodontal tissues ( gingival index=0, plaque index<1, probing depths<3mm, no peridontal attachment loss and no radiographic evidence of periodontal bone loss) Exclusion Criteria: - gingivitis/ periodontitis - interproximal fillings - missing teeth - crowding or spacing in premolar or molar area - severe systemic disease - antibiotics or analgesics prescribed 15 days prior/during study |
Country | Name | City | State |
---|---|---|---|
Croatia | University Hospital Rijeka | Rijeka |
Lead Sponsor | Collaborator |
---|---|
University Hospital Rijeka | University of Zagreb |
Croatia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assesment of pain | The pain was assessed with a visual analogue scale (VAS), which is a 100-mm-long hori-zontal line where one end corresponds to "no pain" and the other end indicates "worst pain possible." The participants filled out the questionnaire immediately after the placement of separators (TO) and before 1st laser treatment, 12 hours (T1), 24hours (T2) and just after 2nd laser treatment, 2 days (T3) and 3 days after the 1st treatment (T4) (Table 1). At each evalua-tion period, the degree of pain was scored twice, one for each side. Each patient was re-quired to indicate whether he/she had taken any analgesics during the recorded period. | 3 days |