Treatment of Peri-Implant Mucositis With Standard of Care and Bioptron Hyperlight Therapy

Treatment of Peri-Implant Mucositis With Standard of Care and Bioptron Hyperlight Therapy: A Parallel-Arm Clinical Trial

Objectives:

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

Study Overview

• Status: Completed
• Conditions: Dental Implant Failed; Mucositis Oral
• Intervention / Treatment: Device: Photobiomodulation with Bioptron Hyperlight Therapy

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bari, Italy, 70121
    • Roberto Felice Grassi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female, 30-60 years old.
• 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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Device: 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.
Experimental: 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	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Periodontal chart-Probing pocket depth (PPD)	Probing pocket depth (PPD). PPD is a periodontal index. It is used to measure the depth of the tissue surrounding the dental implant; with notches measured in millimeters. The probe is placed in between the dental implant and gums and measures the depth of what is called the periodontal pocket- the space between the dental implant and the surrounding gums and bone.	Patients were assessed before study beginning (baseline)
Periodontal chart-Probing pocket depth (PPD)	Probing pocket depth (PPD). PPD is a periodontal index. It is used to measure the depth of the tissue surrounding the dental implant; with notches measured in millimeters. The probe is placed in between the dental implant and gums and measures the depth of what is called the periodontal pocket- the space between the dental implant and the surrounding gums and bone.	Patients were assessed at 6 weeks (T1)
Periodontal chart-Probing pocket depth (PPD)	Probing pocket depth (PPD). PPD is a periodontal index. It is used to measure the depth of the tissue surrounding the dental implant; with notches measured in millimeters. The probe is placed in between the dental implant and gums and measures the depth of what is called the periodontal pocket- the space between the dental implant and the surrounding gums and bone.	Patients were assessed at 12 weeks (T2)
Periodontal chart-Probing pocket depth (PPD)	Probing pocket depth (PPD). PPD is a periodontal index. It is used to measure the depth of the tissue surrounding the dental implant; with notches measured in millimeters. The probe is placed in between the dental implant and gums and measures the depth of what is called the periodontal pocket- the space between the dental implant and the surrounding gums and bone.	Patients were assessed at 24 weeks (T3)
Periodontal chart-Bleeding on probing (BOP)	Bleeding on probing (BOP). Bleeding on probing (BOP) is a parameter to measure soft tissue inflammation. It is measured with the use of a dental probe. The grading is : 0: normal colour of gingiva, no inflammation, no bleeding;; 1: slight inflammation; no bleeding;; 2: moderate inflammation; presence of bleeding on probing;; 3: severe inflammation; tendency to spontaneus bleeding.	Patients were assessed before study beginning (baseline)
Periodontal chart-Bleeding on probing (BOP)	Bleeding on probing (BOP). Bleeding on probing (BOP) is a parameter to measure soft tissue inflammation. It is measured with the use of a dental probe. The grading is : 0: normal colour of gingiva, no inflammation, no bleeding;; 1: slight inflammation; no bleeding;; 2: moderate inflammation; presence of bleeding on probing;; 3: severe inflammation; tendency to spontaneus bleeding.	Patients were assessed at 6 weeks (T1)
Periodontal chart-Bleeding on probing (BOP)	Bleeding on probing (BOP). Bleeding on probing (BOP) is a parameter to measure soft tissue inflammation. It is measured with the use of a dental probe. The grading is : 0: normal colour of gingiva, no inflammation, no bleeding;; 1: slight inflammation; no bleeding;; 2: moderate inflammation; presence of bleeding on probing;; 3: severe inflammation; tendency to spontaneus bleeding.	Patients were assessed at 12 weeks (T2)
Periodontal chart-Bleeding on probing (BOP)	Bleeding on probing (BOP). Bleeding on probing (BOP) is a parameter to measure soft tissue inflammation. It is measured with the use of a dental probe. The grading is : 0: normal colour of gingiva, no inflammation, no bleeding;; 1: slight inflammation; no bleeding;; 2: moderate inflammation; presence of bleeding on probing;; 3: severe inflammation; tendency to spontaneus bleeding.	Patients were assessed at 24 weeks (T3)
Periodontal chart- Plaque index (PI)	Plaque index (PI). Plaque index is used to evaluate the level and rate of plaque formation on dental implant surfaces. The grading is : 0: no visible plaque;; 1: thin plaque layer detectable by scraping;; 2: moderate plaque layer; visible to the naked eye;; 3: abundant plaque layer.	Patients were assessed before study beginning (baseline)
Periodontal chart- Plaque index (PI)	Plaque index (PI). Plaque index is used to evaluate the level and rate of plaque formation on dental implant surfaces. The grading is : 0: no visible plaque;; 1: thin plaque layer detectable by scraping;; 2: moderate plaque layer; visible to the naked eye;; 3: abundant plaque layer.	Patients were assessed at 6 weeks (T1)
Periodontal chart- Plaque index (PI)	Plaque index (PI). Plaque index is used to evaluate the level and rate of plaque formation on dental implant surfaces. The grading is : 0: no visible plaque;; 1: thin plaque layer detectable by scraping;; 2: moderate plaque layer; visible to the naked eye;; 3: abundant plaque layer.	Patients were assessed at 12 weeks (T2)
Periodontal chart- Plaque index (PI)	Plaque index (PI). Plaque index is used to evaluate the level and rate of plaque formation on dental implant surfaces. The grading is : 0: no visible plaque;; 1: thin plaque layer detectable by scraping;; 2: moderate plaque layer; visible to the naked eye;; 3: abundant plaque layer.	Patients were assessed at 24 weeks (T3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain relief	Pain relief assessed with the Numerical Rating Scale-11 (NRS-11)	Patients were assessed before study beginning (baseline)
Pain relief	Pain relief assessed with the Numerical Rating Scale-11 (NRS-11)	Patients were assessed at 6 weeks (T1)
Pain relief	Pain relief assessed with the Numerical Rating Scale-11 (NRS-11)	Patients were assessed at 12 weeks (T2)
Pain relief	Pain relief assessed with the Numerical Rating Scale-11 (NRS-11)	Patients were assessed at 24 weeks (T3)

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza
• Investigators: Study Director: Roberto F Grassi, Prof, University of Bari Aldo Moro

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2020
• Primary Completion (Actual): January 10, 2021
• Study Completion (Actual): January 13, 2022

Study Registration Dates

• First Submitted: March 22, 2022
• First Submitted That Met QC Criteria: March 31, 2022
• First Posted (Actual): April 1, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 31, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: dental implants; photobiomodulation; peri-implant mucositis; Bioptron
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis; Stomatitis
• Other Study ID Numbers: 3464/23.12.2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No