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

Dental Implant Failed Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05307445
• Other study ID #: 3464/23.12.2016
• Status: Completed
• Phase: N/A
• Start date: January 7, 2020
• Est. completion date: January 13, 2022

Study information

• Verified date: March 2022
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 13, 2022
• Est. primary completion date: January 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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: -

Related Conditions & MeSH terms

• Dental Implant Failed
• Mucositis
• Mucositis Oral
• Stomatitis

Intervention

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.

Locations

Country	Name	City	State
Italy	Roberto Felice Grassi	Bari

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Pain relief	Pain relief assessed with the Numerical Rating Scale-11 (NRS-11)	Patients were assessed before study beginning (baseline)
Secondary	Pain relief	Pain relief assessed with the Numerical Rating Scale-11 (NRS-11)	Patients were assessed at 6 weeks (T1)
Secondary	Pain relief	Pain relief assessed with the Numerical Rating Scale-11 (NRS-11)	Patients were assessed at 12 weeks (T2)
Secondary	Pain relief	Pain relief assessed with the Numerical Rating Scale-11 (NRS-11)	Patients were assessed at 24 weeks (T3)