Treatment of Peri-Implant Mucositis With Standard of Care and Bioptron Hyperlight Therapy
NCT ID: NCT05307445
Last Updated: 2022-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2020-01-07
2022-01-13
Brief Summary
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The aim of this study was to evaluate in a cohort of patients with peri-implant mucositis: (a) the efficacy of professional mechanical debridement therapy assisted using Bioptron Hyperlight Therapy on the reduction of periodontal indexes (b) the reduction of total oxidative salivary stress.
Material and Methods Forty subjects with a diagnosis of peri-implant mucositis were enrolled in this study and randomly assigned to the study group (mechanical debridement therapy assisted using Bioptron Hyperlight Therapy) or control group (mechanical debridement therapy alone). The study duration was 6 months. Data on plaque index (PI), bleeding on probing (BoP), probing pocket depth (PPD) and pain relief on Visual Analogue Scale (VAS) were recorded at T0, T1 (14 days), T2 (1 month) and T3 (6 months). Group differences were assessed using Student's t-test and Pearson's Chi-squared test of homogeneity
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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peri-implant mucositis treated with standard of care-professional mechanical debridement
patients with peri-implant mucositis are treated with standard of care, i.e. professional mechanical debridement
Photobiomodulation with Bioptron Hyperlight Therapy
The Bioptron® Device provides polarized visible polychromatic noncoherent light with 90 W; light wavelength = 480-3400 nm; degree of polarization = 95%; specific power = 40 mW/cm2; energy density = 2.4 J/cm2. The duration of each treatment session was 10 min. Bioptron light was positioned 10 cm from the oral mucosa and a mouth opener was positioned for the entire duration of the session. Two weekly sessions during the first 4 weeks of treatment were applied.
peri-implant mucositis treated with photobiomodulation in addition to standard treatment
patients with peri-implant mucositis are treated with photobiomodulation in addition to standard treatment
Photobiomodulation with Bioptron Hyperlight Therapy
The Bioptron® Device provides polarized visible polychromatic noncoherent light with 90 W; light wavelength = 480-3400 nm; degree of polarization = 95%; specific power = 40 mW/cm2; energy density = 2.4 J/cm2. The duration of each treatment session was 10 min. Bioptron light was positioned 10 cm from the oral mucosa and a mouth opener was positioned for the entire duration of the session. Two weekly sessions during the first 4 weeks of treatment were applied.
Interventions
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Photobiomodulation with Bioptron Hyperlight Therapy
The Bioptron® Device provides polarized visible polychromatic noncoherent light with 90 W; light wavelength = 480-3400 nm; degree of polarization = 95%; specific power = 40 mW/cm2; energy density = 2.4 J/cm2. The duration of each treatment session was 10 min. Bioptron light was positioned 10 cm from the oral mucosa and a mouth opener was positioned for the entire duration of the session. Two weekly sessions during the first 4 weeks of treatment were applied.
Eligibility Criteria
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Inclusion Criteria
* With diagnosis of peri-implant mucositis.
* Plaque index (PI) ≥ 40%.
* Al least one implant site with PPD≥4 mm, BOP+ and suppuration.
* No uncontrolled diabetes, cardiovascular diseases, bone metabolism disorders, no autoimmune diseases (lichen planus, pemphigoid, pemphigus and systemic lupus erythematosus).
* No pharmacological therapies, no chemo-radiotherapies.
* No smoking (\>10 cigarettes/day), alcohol and/or drug consumption.
* No pregnancy or breastfeeding.
* No allergy.
Exclusion Criteria
ALL
No
Sponsors
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University of Roma La Sapienza
OTHER
Responsible Party
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Gianna Maria Nardi
Clinical Professor
Principal Investigators
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Roberto F Grassi, Prof
Role: STUDY_DIRECTOR
University of Bari Aldo Moro
Locations
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Roberto Felice Grassi
Bari, , Italy
Countries
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References
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Nardi GM, Mazur M, Papa G, Petruzzi M, Grassi FR, Grassi R. Treatment of Peri-Implant Mucositis with Standard of Care and Bioptron Hyperlight Therapy: A Randomized Clinical Trial. Int J Environ Res Public Health. 2022 May 7;19(9):5682. doi: 10.3390/ijerph19095682.
Other Identifiers
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3464/23.12.2016
Identifier Type: -
Identifier Source: org_study_id
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