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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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REBEC |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
RBR-4z7cnh |
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Date of registration:
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11/04/2011 |
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Primary sponsor: |
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Public title:
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Facial edema reduction by manual lymphatic drainage at postoperative alveolar bone grafting.
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Scientific title:
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Randomized open controlled parallel trial on the facial edema reduction following alveolar bone grafting by manual lymphatic drainage. |
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Date of first enrolment:
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Target sample size:
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40 |
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Recruitment status: |
recruitment completed |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-4z7cnh/ |
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Study type:
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Study design:
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Randomized open controlled parallel trial
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Alceu
Trindade Jr |
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Address:
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Rua Silvio Marchione 3-20
17012-900
Bauru
Brazil |
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Telephone:
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(14)32358066 |
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Email:
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atrind@usp.br |
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Affiliation:
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Hospital de Reabilitação de Anomalias Craniofaciais/ USP |
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Name:
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Alceu
Trindade Jr |
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Address:
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Rua Silvio Marchione 3-20
17012-900
Bauru
Brazil |
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Telephone:
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(14)32358066 |
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Email:
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atrind@usp.br |
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Affiliation:
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Hospital de Reabilitação de Anomalias Craniofaciais/ USP |
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Key inclusion & exclusion criteria
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Inclusion criteria: cleft lip and palate
Exclusion criteria: hypertension
Age minimum:
10Y
Age maximum:
14Y
Gender:
-
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Health Condition(s) or Problem(s) studied
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facial swelling after alveolar bone grafting C05.500.460.185
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Q00-Q99
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Intervention(s)
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Treatment group: 29 patients (17 females and 12 males) were submitted to the manual lymphatic drainage (MLD) procedures using specific and standardized techniques always performed by the author, for 30 minutes, in a calm and comfortable environment, with the patient lying on a bed with the headboard raised at 20 degrees. The MLD procedures were performed from the second to the fourth postoperative days, in a different manner in the two groups. After de MDL maneuver, 23 patients were questioned about the reduction of pain, sensation of relaxation and sleep after therapy on the 2ndPO (postoperative), 3rd PO and 4thPO. Control group: 22 patients (7 females and 15 males) were submitted to the procedures routinely performed by the patients themselves after professionals of HRAC/USP teach and explain the MDL procedures, which are then performed by the patients themselves or by their caretakers. The patients and caretakers were taught to perform MDL procedures by pumping on the submandibular lymph nodes and superficial sliding only on the operated hemiface for 10 minutes, three times a day, as well as facial mimic exercises (lip protraction, lateral traction of the angle of the mouth, smiling, and strongly opening and closing the eyes). All procedures were performed without additional cost to the patient.Pumping, superficial sliding and stationary circles were performed on the face, applying light pressure with the hands according to the Vodder technique always toward the adjacent lymph nodes, in a slow and constant rhythim. Pumping was performed on the supramandibular, submental and preauricular lymph nodes. The face was divided into three parts, lower, medium and upper regions.After MLD, the patients performed facial mimic exercises, six times each (opening and closing the eyes, contractions of nose and nasal ala muscles, protraction of closed lips, protraction and lateral movement of the lips, and distention of open lips). All patients were submitted to the pharmacol
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Primary Outcome(s)
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In both groups, in the period before the manual lymphatic drainage (MLD) the edema and interincisal distance were evaluated preoperativly (Pre), second (2ndPO) and fourth days postoperatively (4thPO), and pain analogue scale (PAS) on the first, second, third and fourth days postoperatively. For the achievement of facial dimensions, three points were marked on the face using a surgical marker, forming two lines. The following dimensions were achieved using a conventional measuring tape: distance between nasal ala and tragus (line 1), and distance between nasal ala and inferior regions of the ear (line 2), The measurements were achieves on the operated hemiface, three times and the mean value was considered for the analysis. The maximum active interincisal distance (MAID) was evaluated with a manual pachymeter on the side with the best dental arch alignment.In the treatment group, after MLD, 23 patients were questioned on the therapy on the 2ndPO, 3rdPO and 4thPO. The mean values obtained in the treatment group was 11,03 cm in the preoperatively period (Pre) and 11,59 in 4thPO (line 1, p<0,05). For the line 2, the values were 10,37 cm (Pre) and 10,85 cm in the 4thPO (p<0,05).The values of the MAID in the treatment group were 4,02 cm in the preoperatively period (Pre) and 3,17 cm in the 4thPO. There is a significant reduction (p<0,05) in the mean values of the lines 1,2 and MAID when both groups were compared.
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Secondary ID(s)
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350/2010-SVAPEPE-CEP
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Source(s) of Monetary Support
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Hospital de Reabilitação de Anomalias Craniofaciais/ USP - Brazil
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