CClinicalTrials.gg
Status unknownNCT02995070Updated Dec 16, 2016

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

An interventional study of CTG and LLLT in Gingival Recession, sponsored by Universidade Estadual Paulista Júlio de Mesquita Filho. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-16.

Sponsored by Universidade Estadual Paulista Júlio de Mesquita Filho · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Gingival Recession

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03

In context

Gingival Recession

402 studies on the registry are indexed under Gingival Recession; 98 are open to participants now.

This study's planned enrollment of 30 is close to the median of 30 across 368 interventional studies indexed under Gingival Recession.

Browse Gingival Recession studies →

Lead sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho is the lead sponsor of 82 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    CTG + LLLT

    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.

    Procedure: CTG · Device: LLLT

  • Sham comparator
    CTG + SHAM

    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.

    Procedure: CTG · Device: SHAM

Interventions

  • ProcedureCTG

    Periodontal plastic surgery for root coverage by the trapezoidal flap plus connective tissue graft

    Also known as: Periodontal plastic surgery

  • DeviceLLLT

    Low Level Laser Therapy on the buccal recipient site of connective tissue graft.

    Also known as: Low level GaAlAs laser

  • DeviceSHAM

    Simulation of GaAlAs laser to irradiation on connective tissue graft recipient site.

    Also known as: Low level GaAlAs laser sham

06

What researchers measure

Primary outcomes

  1. Percentage of defect coverage

    Time frame: 6 months

Secondary outcomes

  1. Root coverage esthetic score

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Felipe Lucas da Silva Neves
    Sao Jose dos Campos, São Paulo 12243-700, Brazil
    Recruiting
08

References and documents

Publications

  • 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. PubMed 21750957 ↗
  • 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. PubMed 22092477 ↗
  • 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. PubMed 3866056 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02995070
Lead sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
Responsible party
Mauro Pedrine Santamaria (Assistant Professor, Universidade Estadual Paulista Júlio de Mesquita Filho) — Principal investigator
First posted
Dec 16, 2016
Start date
Sep 2016
Primary completion
Jul 2017 (estimated)
Completion
Jul 2017 (estimated)
Last update
Dec 16, 2016

Study contacts

Mauro P Santamaria, PhD
Contact
mauro.santamaria@ict.unesp.br
+55 (16) 981937777
Mauro P Santamaria, PhD
principal investigator · ICT-UNESP

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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