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Laterally closed tunnel technique with and without adjunctive photobiomodulation therapy for the management of isolated gingival recession-a randomized controlled assessor-blinded clinical trial.

ABSTRACT: The objective of this prospective randomized controlled single-center clinical trial was to prove the efficacy of adjunctive photobiomodulation in improving selected outcomes following the use of laterally closed tunnel technique for the management of isolated gingival recession. Nineteen participants (with isolated gingival recession) each treated by laterally closed tunnel technique were randomized to either add on treatment with control (sham laser application) or test group (photobiomodulation with 660 nm diode, 3.5 J/cm² per point of application). The primary outcome variable was change in recession depth and secondary variables included recession width, width of keratinized gingiva, periodontal biotype, and VAS score for pain assessment and EHS index for early wound healing assessment. Analysis was performed using a linear mixed effects model. There were no significant differences in the gingival recession depth (p = 0.8324) and recession width (p-0.969) at 3-month follow-up. The VAS scores were significantly lower for the test (laterally closed tunnel technique + photobiomodulation) group as compared to control (laterally closed tunnel technique + sham laser) over time (p = < 0.0001) as well as per site (p = 0.0006) The Early Wound Healing Index scores were significantly higher in the test (laterally closed tunnel technique + photobiomodulation) group as compared to control (laterally closed tunnel technique + sham laser) group (p < 0.0001). The adjunctive use of photobiomodulation did not show a better outcome concerning recession depth but appears to provide faster healing of the surgical wounds and better patient comfort. The result needs further evaluation in particular with respect to long-term effect and due to limitation in sample size. Clinical Trial Registry of India: CTRI/2019/11/022012.

SUBMITTER: Lavu V

PROVIDER: S-EPMC8452278 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionTotal knee replacement (TKR) is a surgical procedure that is being increasingly performed as a result of population aging and the increased average human life expectancy in South Korea. Consistent with the growing number of TKR procedures, the number of patients seeking acupuncture for relief from adverse effects, effective pain management, and the enhancement of rehabilitative therapy effects and bodily function after TKR has also been increasing. Thus, an objective examination of the evidence regarding the safety and efficacy of acupuncture treatments is essential. The aim of this study is to verify the hypothesis that the concurrent use of acupuncture treatment and usual care after TKR is more effective, safe, and cost-effective for the relief of TKR symptoms than usual care therapy alone.Methods/designThis is an open-label, parallel, assessor-blinded randomized controlled trial that includes 50 patients with TKR. After screening the patients and receiving informed consent, the patients are divided into two groups (usual care + acupuncture group and usual care group); the patients will then undergo TKR surgery and will be hospitalized for 2 weeks. The patients will receive a total of 8 acupuncture treatments over 2 weeks after surgery and will be followed up at 3, 4, and 12 weeks after the end of the intervention. The primary outcome is assessed using the Korean version of the Western Ontario and McMaster Universities Arthritis Index (K-WOMAC), and the secondary outcome is measured using the Numerical Rating Scale (NRS), Risk of Fall, and Range of Motion (ROM). Moreover, the cost per quality-adjusted life years (QALYs) is adopted as a primary economic outcome for economic evaluation, and the cost per NRS is adopted as a secondary economic outcome.Ethics and disseminationThis trial has received complete ethical approval from the Ethics Committee of Catholic Kwandong University International St. Mary's Hospital (IS17ENSS0063). We intend to submit the results to a peer-reviewed journal and/or conferences.Trial registrationClinicalTrials.gov Identifier: NCT03633097.

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Laterally closed tunnel technique with and without adjunctive photobiomodulation therapy for the management of isolated gingival recession-a randomized controlled assessor-blinded clinical trial.

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