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

Gingival Recession Clinical Trial

Official title:

The Influence Low Intensity Laser Therapy (LILT) in Connective Tissue Graft for Root Coverage in Smokers. A Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02995070
• Other study ID #: UEPJMF 7
• Status: Recruiting
• Phase: N/A
• First received: December 13, 2016
• Last updated: December 13, 2016
• Start date: September 2016
• Est. completion date: July 2017

Study information

• Verified date: December 2016
• Source: Universidade Estadual Paulista Júlio de Mesquita Filho
• Contact: Mauro P Santamaria, PhD
• Phone: +55 (16) 981937777
• Email: mauro.santamaria[@]ict.unesp.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• CTG
Periodontal plastic surgery for root coverage by the trapezoidal flap plus connective tissue graft

Device:
• LLLT
Low Level Laser Therapy on the buccal recipient site of connective tissue graft.
• SHAM
Simulation of GaAlAs laser to irradiation on connective tissue graft recipient site.

Locations

Country	Name	City	State
Brazil	Felipe Lucas da Silva Neves	Sao Jose dos Campos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Estadual Paulista Júlio de Mesquita Filho

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. — View Citation

Langer B, Langer L. Subepithelial connective tissue graft technique for root coverage. J Periodontol. 1985 Dec;56(12):715-20. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of defect coverage		6 months	Yes
Secondary	Root coverage esthetic score		6 months	Yes