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Low-intensity Laser Therapy in the Treatment of Gingival Recession (LILT)

Primary Purpose

Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Connective tissue graft
Sponsored by
UPECLIN HC FM Botucatu Unesp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. presenting Miller class I or II gingival recession in the maxillary canines or premolars;
  2. visible cemento-enamel junction (CEJ) in the teeth included in the study and pulp vitality;
  3. patients presenting no signs of active periodontal disease and full-mouth plaque and bleeding score ≤ 20%;
  4. patients older than 18 years old;
  5. probing depth ˂ 3 mm in the included teeth; 6) patients who agreed to participate and signed an informed consent form

Exclusion Criteria:

  1. patients with systemic problems (cardiovascular, blood dyscrasias, immunodeficiency, and diabetes, among others) that will contraindicate the surgical procedure
  2. patients taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure
  3. smokers or pregnant women
  4. patients who underwent periodontal surgery in the area of interest; and 5) patients with orthodontic therapy in progress.

Sites / Locations

  • UNESP - ICT Odontologia São José dos Campos

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Connective tissue graft (CTG)

Connective tissue graft plus laser (CTG+L)

Arm Description

The gingival recession defects were treated by connective tissue graft surgical procedure and received the sham application os low-intensity laser therapy.

The gingival recession defects were treated by connective tissue graft associated with the application of a LILT protocol

Outcomes

Primary Outcome Measures

Percentage of root coverage

Secondary Outcome Measures

Esthetic
Two esthetic evaluations were performed: 1 professional and 1 patient-centered. The professional esthetic evaluation was made using the photographs of the baseline and 6 months after surgery set in a before-and-after panel. The professional evaluation was conducted using the root coverage esthetic score (RES). Esthetic outcomes were also evaluated from the patient's point of view. Using a hand mirror, the patients viewed the gingival recession before and after 6 months and were asked to rate the esthetics of the tooth included in the study on a VAS scale.

Full Information

First Posted
April 16, 2014
Last Updated
April 17, 2014
Sponsor
UPECLIN HC FM Botucatu Unesp
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1. Study Identification

Unique Protocol Identification Number
NCT02118155
Brief Title
Low-intensity Laser Therapy in the Treatment of Gingival Recession
Acronym
LILT
Official Title
Connective Tissue Graft Associated or Not With Low Intensity Laser Therapy: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UPECLIN HC FM Botucatu Unesp

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study was to evaluate the 6-month outcomes of applying low-intensity laser therapy associated with connective tissue grafts to treat gingival recession.
Detailed Description
This was a prospective, parallel and controlled clinical trial. The population evaluated in this study was selected at ICT - São José dos Campos, College of Dentistry. The selected patients were randomly allocated (by a computer generated list) into: Group CTG (n = 20) - patients who received connective tissue graft to treat gingival recession Group CTG+LILT (n = 20) - patients who received connective tissue graft associated with 8 applications of low-intensity laser therapy to treat gingival recession. The surgeries, as well as all postoperative follow-up, were performed at the dental clinic of ICT- UNESP. Surgical areas were anesthetized (2% mepivacaine with 1:100,000 epinephrine). Two horizontal incisions were made at right angles to the adjacent interdental papillae, at the level of the CEJ, without interfering with the gingival margins of neighboring teeth. Two oblique vertical incisions were extended beyond the mucogingival junction, and a trapezoidal mucoperiosteal flap was raised up to the mucogingival junction. After this point, a split-thickness flap was extended apically, releasing the tension and favoring coronal positioning of the flap. The exposed root surface was gently scaled and planed to remove any possible irregularities. Afterward, a thin and small connective tissue graft was harvested from the palate using a scalpel with parallel blades (1.0 mm away from each other). The graft was sutured# using single sutures in the papillae, over the root surface, in such a way that covered the CEJ and the recession. Then, the flap was coronally positioned and sutured to completely cover the graft The patients allocated for the test group received the following protocol for laser application: Five (5) points of irradiation were performed, as depicted in Figure 1. The irradiation was performed with a GaAlAs** diode laser that continuously emitted a wavelength of 660 nm. 30 mW was used for 20 seconds, and the total applied energy density (fluence) was 15 J/cm2 (3 J/cm2 per point and an application time of 4 seconds per point) Clinical parameters were assessed at baseline and 3 and 6 months post-operatively. Statistical Analysis The null hypothesis considered in the study was the absence of difference in the clinical parameters between the different groups. For data analysis, the statistical program was used (Sigmaplot). The demographic and clinical data were compared between the groups using Student's t-test. The data were first analyzed for homogeneity using the Shapiro-Wilk test, which indicated non-normal distribution. . 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 VAS were analyzed by T-tests. The frequency of sites that were scored as very good or excellent in each group by QCE analysis, the frequency of complete root coverage, BOP, and the presence or absence of plaque at the site were compared using χ2 tests. Intergroup 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
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Connective tissue graft (CTG)
Arm Type
Sham Comparator
Arm Description
The gingival recession defects were treated by connective tissue graft surgical procedure and received the sham application os low-intensity laser therapy.
Arm Title
Connective tissue graft plus laser (CTG+L)
Arm Type
Experimental
Arm Description
The gingival recession defects were treated by connective tissue graft associated with the application of a LILT protocol
Intervention Type
Procedure
Intervention Name(s)
Connective tissue graft
Intervention Description
Periodontal surgical technique to treat gingival recessions
Primary Outcome Measure Information:
Title
Percentage of root coverage
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Esthetic
Description
Two esthetic evaluations were performed: 1 professional and 1 patient-centered. The professional esthetic evaluation was made using the photographs of the baseline and 6 months after surgery set in a before-and-after panel. The professional evaluation was conducted using the root coverage esthetic score (RES). Esthetic outcomes were also evaluated from the patient's point of view. Using a hand mirror, the patients viewed the gingival recession before and after 6 months and were asked to rate the esthetics of the tooth included in the study on a VAS scale.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: presenting Miller class I or II gingival recession in the maxillary canines or premolars; visible cemento-enamel junction (CEJ) in the teeth included in the study and 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; 6) patients who agreed to participate and signed an informed consent form Exclusion Criteria: patients with systemic problems (cardiovascular, blood dyscrasias, immunodeficiency, and diabetes, among others) that will 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; and 5) patients with orthodontic therapy in progress.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie B Fernandes-Dias, DDS, Ms
Organizational Affiliation
UPECLIN HC FM Botucatu Unesp
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maria Aparecida N Jardini, PhD
Organizational Affiliation
UPECLIN HC FM Botucatu Unesp
Official's Role
Study Chair
Facility Information:
Facility Name
UNESP - ICT Odontologia São José dos Campos
City
São José dos Campos
State/Province
São Paulo
ZIP/Postal Code
12243-300
Country
Brazil

12. IPD Sharing Statement

Citations:
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
27834120
Citation
Santamaria MP, Fernandes-Dias SB, Araujo CF, Lucas da Silva Neves F, Mathias IF, Rebelato Bechara Andere NM, Neves Jardini MA. 2-Year Assessment of Tissue Biostimulation With Low-Level Laser on the Outcomes of Connective Tissue Graft in the Treatment of Single Gingival Recession: A Randomized Clinical Trial. J Periodontol. 2017 Apr;88(4):320-328. doi: 10.1902/jop.2016.160391. Epub 2016 Nov 11.
Results Reference
derived
PubMed Identifier
25363203
Citation
Fernandes-Dias SB, de Marco AC, Santamaria M Jr, Kerbauy WD, Jardini MA, Santamaria MP. Connective tissue graft associated or not with low laser therapy to treat gingival recession: randomized clinical trial. J Clin Periodontol. 2015 Jan;42(1):54-61. doi: 10.1111/jcpe.12328. Epub 2014 Dec 17.
Results Reference
derived

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Low-intensity Laser Therapy in the Treatment of Gingival Recession

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