|
Main
|
|
Note: This record shows only 22 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. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT02239042 |
|
Date of registration:
|
02/09/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Effect of Low-level Laser Therapy on Palatal Wound Healing
LLLT |
|
Scientific title:
|
Effect of Gallium-Aluminum-Arsenide Laser - AsGaAl Low-level Laser Therapy on the Healing of Human Palate Mucosa After Connective Tissue Graft Harvesting: Randomized Clinical Trial |
|
Date of first enrolment:
|
October 2011 |
|
Target sample size:
|
32 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT02239042 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Brazil
| | | | | | | |
|
Contacts
|
|
Name:
|
Mauro Santamaria, DDS, Ms, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
FOSJC-UNESP |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Patients that were 20 to 70 years old, both genders; presenting gingival recession
Class I or II Miller, on vital canines or pre-molars, palatine region (donor site)
with no pathological or morphological alterations; patients who agreed with and
signed the formal consent to participate in the study, after receiving an explanation
of risks and benefits, by an individual who was not a member of the present study
(Resolution no. 196 - October, 1996, and Ethics and Code of Professional Conduct in
Dentistry - CFO 179/93).
Exclusion Criteria:
- Patients with systemic problems that contraindicated surgical procedure; patients
under medication that would interfere with the wound healing; patients who smoked;
patients who were pregnant or lactating; patients who had had periodontal surgery on
the study area.
Age minimum:
20 Years
Age maximum:
70 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Palatal Wound
|
|
Intervention(s)
|
|
Procedure: LLLT
|
|
Primary Outcome(s)
|
|
Change in the Remaining wound area (RWA)
[Time Frame: 7, 14, 45 and 60 post-operative days]
|
|
Secondary Outcome(s)
|
|
Post-operative discomfort
[Time Frame: 7, 14, 45 and 60 days after surgical procedure]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|