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

NCT02995070 | Unknown

• 1 other identifier: UEPJMF 7
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

• Percentage of defect coverage

  6 months

Secondary Outcomes (1)

• Root coverage esthetic score

  6 months

Study Arms (2)

CTG + LLLT

EXPERIMENTAL

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

CTG + SHAM

SHAM COMPARATOR

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

CTG PROCEDURE

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

Also known as: Periodontal plastic surgery

CTG + LLLT; CTG + SHAM

LLLT DEVICE

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

Also known as: Low level GaAlAs laser

CTG + LLLT

SHAM DEVICE

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

Also known as: Low level GaAlAs laser sham

CTG + SHAM

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Estadual Paulista Júlio de Mesquita Filho: lead

Study Sites (1)

Felipe Lucas da Silva Neves

São José dos Campos, São Paulo, 12243-700, Brazil

RECRUITING

Related 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. Epub 2011 Jul 13.

  PMID: 21750957 BACKGROUND

• 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.

  PMID: 22092477 BACKGROUND

• 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.

  PMID: 3866056 BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Mauro P Santamaria, PhD

  ICT-UNESP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mauro P Santamaria, PhD

CONTACT

+55 (16) 981937777; mauro.santamaria@ict.unesp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: December 16, 2016
• Study Start: September 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: December 16, 2016

Record last verified: 2016-12

Locations

BR (1)