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Low Intensity Laser Therapy in Connective Tissue Graft for Root Coverage in Smokers

Primary Purpose

Gingival Recession

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
CTG
LLLT
SHAM
Sponsored by
Universidade Estadual Paulista Júlio de Mesquita Filho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients presenting Miller class I or II gingival recession in the maxillary canines or premolars
  • Visible cemento-enamel junction (CEJ) with pulp vitality;
  • Patients presenting no signs of active periodontal disease and full-mouth plaque and bleeding score ≤20%;
  • Patients older than 18 years old; probing depth ˂3 mm in the included teeth;
  • Patients who agreed to participate and signed an informed consent form.

Exclusion Criteria:

  • Patients presenting systemic problems that would contraindicate the surgical procedure;
  • Patients taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure;
  • Smokers or pregnant women;
  • Patients who underwent periodontal surgery in the area of interest;
  • Patients with orthodontic therapy in progress.

Sites / Locations

  • Felipe Lucas da Silva NevesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

CTG + LLLT

CTG + SHAM

Arm Description

The irradiation will be performed with a GaAlAs diode laser that will continuously emits a wavelength of 660 nm with a power of 30 milliwatts. The patients allocated for the LLLT group will receive the following protocol for laser application: Five (5) points of irradiation will be performed using a total energy density (fluence) of 15 J/cm2 and a time of 20 seconds. During irradiation, the tip of the laser probe will be placed perpendicularly with slight contact on the area. Laser therapy will be initiated in the immediate postoperative period (just after sutures) and will be repeated by seven more applications performed every other day, with a total of 8 laser applications. The power of the equipment will be calibrated prior to each application.

The patients allocated to the control group will receive sham irradiation. For this, black rubber protection will be placed at the tip of the laser device, which will not allow the light to reach the tissue. The applications will be performed by a different operator from the one who will measure the study parameters. During irradiation, the tip of the laser probe will be placed perpendicularly with slight contact on the area. Laser therapy will be initiated in the immediate postoperative period (just after sutures) and will be repeated by seven more applications performed every other day, with a total of 8 laser applications.

Outcomes

Primary Outcome Measures

Percentage of defect coverage

Secondary Outcome Measures

Root coverage esthetic score

Full Information

First Posted
December 13, 2016
Last Updated
December 13, 2016
Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
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1. Study Identification

Unique Protocol Identification Number
NCT02995070
Brief Title
Low Intensity Laser Therapy in Connective Tissue Graft for Root Coverage in Smokers
Official Title
The Influence Low Intensity Laser Therapy (LILT) in Connective Tissue Graft for Root Coverage in Smokers. A Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to evaluate the influence of therapy with low-intensity laser technique associated with connective tissue graft for root coverage in smokers and compare the results with non- smokers
Detailed Description
This is a prospective, parallel and controlled clinical trial. The population evaluated in the study was selected at Science and Technology Institute - São José dos Campos, College of Dentistry. The selected smokers patients will be randomly allocated by a computer generated list into: Group CTG (n=15): patients who will receive only the connective tissue graft procedure to treat gingival recession and a simulation of laser therapy application (SHAM). Group CTG+ LLLT (n=15): patients who will receive the connective tissue graft procedure to treat gingival recession plus 8 applications of low-level-laser therapy (LLLT) to treat gingival recession. All surgeries will be performed by the same expert periodontist. 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, will be 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 coronally advanced flap (CAF) and the connective tissue graft (CTG) will be removed from palate mucosa . Briefly, a first incision on the palate will be 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 will be 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 will be 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 will be performed to separate the subepithelium connective tissue from the periosteum. Then, the connective tissue graft will be removed from the palate as atraumatically as possible. Single sutures will be made on the palate (4-0 silk) and the graft will be sutured on the receptor site. The irradiation will be performed with a Gallium aluminum arsenide laser (GaAlAs) that continuously emitted a wavelength of 660 nm. Thirty milliwatts will be used for 20 seconds and the total applied energy (fluence) will be 15 Joules per cm2 (3 Joules/ per point and an application time of 4 seconds per point). Clinical, esthetics, and comfort of patients parameters were assessed at baseline, 3 and 6 months after the procedure. Quantitative data were recorded as mean ± standard deviation (SD), and normality was tested using Shapiro-Wilk tests. The probing depth (PD), relative gingival recession (RGR), clinical attachment level (CAL), keratinized tissue thickness (KTT), keratinized tissue width (KTW), and dentin hypersensitivity (DH) values were examined by two-way repeated measures ANOVA to evaluate the differences within and between groups, followed by a Tukey test for multiple comparisons when the Shapiro-Wilk p value was ≥ 0.05. Those presenting Shapiro-Wilk p values < 0.05 were analyzed using a Friedman test (for intragroup comparisons) and Mann-Whitney tests (for intergroup comparisons). Patients' esthetics and discomfort measures using visual analog scale (VAS) were analyzed by T-tests. The frequency of complete root coverage was compared using χ2 tests. Intergroup root coverage esthetic score (RES) comparisons were performed with a T-test. A significance level of 0.05 was adopted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CTG + LLLT
Arm Type
Experimental
Arm Description
The irradiation will be performed with a GaAlAs diode laser that will continuously emits a wavelength of 660 nm with a power of 30 milliwatts. The patients allocated for the LLLT group will receive the following protocol for laser application: Five (5) points of irradiation will be performed using a total energy density (fluence) of 15 J/cm2 and a time of 20 seconds. During irradiation, the tip of the laser probe will be placed perpendicularly with slight contact on the area. Laser therapy will be initiated in the immediate postoperative period (just after sutures) and will be repeated by seven more applications performed every other day, with a total of 8 laser applications. The power of the equipment will be calibrated prior to each application.
Arm Title
CTG + SHAM
Arm Type
Sham Comparator
Arm Description
The patients allocated to the control group will receive sham irradiation. For this, black rubber protection will be placed at the tip of the laser device, which will not allow the light to reach the tissue. The applications will be performed by a different operator from the one who will measure the study parameters. During irradiation, the tip of the laser probe will be placed perpendicularly with slight contact on the area. Laser therapy will be initiated in the immediate postoperative period (just after sutures) and will be repeated by seven more applications performed every other day, with a total of 8 laser applications.
Intervention Type
Procedure
Intervention Name(s)
CTG
Other Intervention Name(s)
Periodontal plastic surgery
Intervention Description
Periodontal plastic surgery for root coverage by the trapezoidal flap plus connective tissue graft
Intervention Type
Device
Intervention Name(s)
LLLT
Other Intervention Name(s)
Low level GaAlAs laser
Intervention Description
Low Level Laser Therapy on the buccal recipient site of connective tissue graft.
Intervention Type
Device
Intervention Name(s)
SHAM
Other Intervention Name(s)
Low level GaAlAs laser sham
Intervention Description
Simulation of GaAlAs laser to irradiation on connective tissue graft recipient site.
Primary Outcome Measure Information:
Title
Percentage of defect coverage
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Root coverage esthetic score
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients presenting Miller class I or II gingival recession in the maxillary canines or premolars Visible cemento-enamel junction (CEJ) with pulp vitality; Patients presenting no signs of active periodontal disease and full-mouth plaque and bleeding score ≤20%; Patients older than 18 years old; probing depth ˂3 mm in the included teeth; Patients who agreed to participate and signed an informed consent form. Exclusion Criteria: Patients presenting systemic problems that would contraindicate the surgical procedure; Patients taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure; Smokers or pregnant women; Patients who underwent periodontal surgery in the area of interest; Patients with orthodontic therapy in progress.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mauro P Santamaria, PhD
Phone
+55 (16) 981937777
Email
mauro.santamaria@ict.unesp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauro P Santamaria, PhD
Organizational Affiliation
ICT-UNESP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Felipe Lucas da Silva Neves
City
Sao Jose dos Campos
State/Province
São Paulo
ZIP/Postal Code
12243-700
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felipe L Neves, Ms
Phone
+ 55 12997993703
Email
fe-lucas21@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21750957
Citation
Garcia VG, Macarini VC, de Almeida JM, Bosco AF, Nagata MJ, Okamoto T, Longo M, Theodoro LH. Influence of low-level laser therapy on wound healing in nicotine-treated animals. Lasers Med Sci. 2012 Mar;27(2):437-43. doi: 10.1007/s10103-011-0956-4. Epub 2011 Jul 13.
Results Reference
background
PubMed Identifier
22092477
Citation
Ozturan S, Durukan SA, Ozcelik O, Seydaoglu G, Haytac MC. Coronally advanced flap adjunct with low intensity laser therapy: a randomized controlled clinical pilot study. J Clin Periodontol. 2011 Nov;38(11):1055-62. doi: 10.1111/j.1600-051X.2011.01774.x. Epub 2011 Sep 15.
Results Reference
background
PubMed Identifier
3866056
Citation
Langer B, Langer L. Subepithelial connective tissue graft technique for root coverage. J Periodontol. 1985 Dec;56(12):715-20. doi: 10.1902/jop.1985.56.12.715.
Results Reference
background

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Low Intensity Laser Therapy in Connective Tissue Graft for Root Coverage in Smokers

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