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Clinical Trial Summary

The aim of this study is to compare the influence of two different energy densities for photobiomodulation on recovery of palatal donor area after free gingival graft technique.

Clinical Trial Description

This is a prospective, parallel and controlled clinical trial. The population evaluated in the study was selected at Science and Technology Institute (STI) -São José dos Campos, College of Dentistry.

Patients were assigned to one of the three treatment groups:

- Group 1: ridge preservation surgery through free gingival graft and photobiomodulation (PBM) application through a gallium aluminum arsenide laser (GaAlAs) in the donor area using a 60 Joule/cm² dose

- Group 2: ridge of preservation surgery through free gingival graft and PBM through a gallium aluminum arsenide laser (GaAlAs) in the donor area using a 15 Joule/cm² dose

- Group 3: ridge preservation surgery through free gingival graft and PBM Sham.

All surgeries were performed by the same expert periodontist (MPS). A blade 15c (Swann-Morton® - Sheffield, England) mounted on No. 3 scalpel handle will make an intrasulcular incision around the tooth indicated for exodontia. Then, the tooth will be extracted through the use of appropriate instruments in order to obtain a minimally traumatic exodontia.

After the exodontia, curettage and irrigation of the dental socket will be performed. After that, the socket will be filled with xenogenous bone graft (GenOx Inorg; Campinas, SP), and sealed with a free gingival graft removed from the palate. For the free gingival graft removal, a circular template of 5 millimeters in diameter will be used. This mold has the objective of standardizing the palatal graft removal ensuring the wounds will have always the same size. After the circular incision, the graft will be removed with a thickness of 2 millimeters. After free gingival graft removal from palate, it will be adjusted to the entrance of the socket and sutured with Vicryl® 5.0 reabsorbable (Ethicon Johnsons do Brasil, São José dos Campos - SP).

The evaluated parameters were wound remaining area (WRA), scar and tissue colorimetry (TC), tissue thickness (TT) and postoperative discomfort (D), evaluated at baseline and 7, 14, 45, 60, and 90 days after surgery.

Statistical Analysis: All data were expressed as mean ± standard deviation or expressed in percentages during the descriptive phase. Data were analyzed according to distribution by the Shapiro-Wilk test. For the remaining wound area, tissue colorimetry, tissue thickness, and postoperative discomfort parameter analysis, two way repeated measures ANOVA was performed for intra- and intergroup analysis. T test was used for intergroup comparison of the number of analgesics taken. The presence or absence of scars was measured by Q-square test. Statistical analysis was performed using Sigma Plot 12.0. In all tests a significance level of 0.05 was chosen. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

NCT number NCT03000426
Study type Interventional
Source Universidade Estadual Paulista Júlio de Mesquita Filho
Contact Mauro P Santamaria, PhD
Phone +55 (16) 981937777
Email [email protected]
Status Recruiting
Phase N/A
Start date November 2016
Completion date February 2018

See also
  Status Clinical Trial Phase
Completed NCT03713073 - Clinical and Histological Outcomes of Allogenic Amnion Chorion Membrane in the Healing of Free Gingival Graft Donor Site N/A
Completed NCT02239042 - Effect of Low-level Laser Therapy on Palatal Wound Healing Phase 4
Recruiting NCT03972267 - Influence of Enamel Matrix Derivative (Emdogain®) on Palate Wound Healing. N/A
Completed NCT02580357 - Comparison of Two Different Low-level Laser Intensity Protocols on the Healing of Palatal Wounds N/A
Recruiting NCT03576339 - Influence of Electrical Stimulation on Palatal Wound Healing. N/A