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Completed

NCT Number: NCT02580357

Comparison of Two Different Low-level Laser Intensity Protocols on the Healing of Palatal Wounds

The aim of this study was to compare two intensities of LLLT on wound healing process of the donor palatine area after CTG removal.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Patients were assigned to one of the three treatment groups:

  • Group 60 (Test, n=18): Periodontal surgery for root coverage through connective tissue graft and LLLT application on donor site using a 60 J/cm² dose.
  • Group 30 (Test, n=18): Periodontal surgery for root coverage through connective tissue graft and LLLT application on donor site using a 30 J/cm² dose.
  • Group Sham (Control, n= 18): Periodontal surgery for root coverage through connective tissue graft and LLLT SHAM on donor site.

All surgeries were performed by the same expert periodontist (MPS). Before the surgical procedure, all patients were enlightened about the causes and consequences of gingival recession and prevention techniques. Factors related to the origin of gingival recession, such as toothbrush trauma and inflammation caused by biofilm, were controlled through instruction on standardized brushing technique to avoid the influence of other hygiene methods capable of promoting trauma on soft tissues. Standardized dental floss and toothbrushes were given to patients. The surgical technique adopted in the recession defects was the trapezoidal-type of CAF and the connective tissue graft was removed from palate mucosa . Briefly, a first incision on the palate was performed perpendicularly to the long axis of the teeth, 2 to 3 mm apical to the gingival margin. The mesial-distal length of the incision was determined by the length of the graft required to cover the recession. Because the selected recessions were in maxillary canines and premolars, the lengths of the graft varied minimally (10-12mm). The second incision was made parallel to the first one (1-2 mm apically and parallel to the long axis of the teeth) to separate the subepithelium connective tissue from the epithelial layer. The incision is carried far enough apically to provide a 7- mm height of connective tissue to cover the denuded root surface. Afterward, another incision parallel to the long axis of the teeth starting from the first incision was performed to separate the subepithelium connective tissue from the periosteum. Then, the connective tissue graft was removed from the palate as atraumatically as possible. Single sutures were made on the palate (4-0 silk) and the graft was sutured on the receptor site.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients were 20 to 70 years old and of both genders, presenting Class I or II Miller gingival recession on vital canines or premolars in the palatine region (donor site) with no pathological or morphological alterations.
  • Patients agreed to and signed the formal consent to participate in the study after receiving an explanation of risks and benefits from 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

  • Were excluded patients with systemic problems that contraindicated surgical procedure
  • Those under medication that could interfere with the wound healing
  • Those who smoked
  • Those who were pregnant or lactating, and
  • Those who had had periodontal surgery on the study area.

Treatment and study plan

low level laser therapy

Procedure

Low Level Laser Therapy on the palatal donor site of connective tissue graft.

Other names: Laser stimulation

GaAlAs laser

Device

Utilization of GaAlAs laser to irradiation on the palatal donor site.

Other names: Low level GaAlAs laser

Primary outcomes

  1. Change in the Remaining Wound Area (RWA)

    Time frame: 7,14, 45 and 60 post operative days

    For this, standardized photographs were taken (brightness, distance and angle). A scale was used as a reference to measure this area. These photographs were exported to image software ( Image J - NIH, Bethesda, USA) and remaining wound area was measured in square millimeters (mm²).

Secondary outcomes

  1. Postoperative Discomfort

    Time frame: 7, 14, 45, and 60 days after surgical procedure

    After air jet application, patients were requested to score postoperative discomfort through on a visual analogue scale (VAS) of 10 centimeters, in which 0 meant "no pain" and 10 meant "extreme pain". After this, a postoperative discomfort average for all groups was obtained.

Other outcomes

  1. Tissue Thickness

    Time frame: Before the procedure and 3 months after the procedure

    Through four fixed points marked 5 and 7 mm from the gingival margin in the operated region, tissue thickness of palatine masticatory mucosa. One stent was made to standardize the points to be measured. The stent was positioned, and with a periodontal probe and the points were marked. Then the stent was removed and measurements were taken. For this, an endodontic spacer with a rubber cursor was put on the marked points for it to reach the palatine bone plate. Then the cursor was taken to the tissue carefully to not pressuring it. The distance between the spacer tip and the cursor was measured using a digital pachymeter and measured in millimeters (mm).

Sponsors and collaborators

Lead sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Other

Registry information

Official study title

Comparison of Two Different Low-level Laser Intensity Protocols on the Healing of Palatal Wounds After Connective Tissue Graft Removal: Randomized Clinical Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 20, 2015
Registry last updated
May 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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