Management of Peri-implant Mucositis With Ozone Water Jet: a Randomized Clinical Trial.

Peri-implant Mucositis Clinical Trial

Official title:

Pilot Study for the Management of Peri-implant Mucositis With Ozone Water Jet: a Randomized Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04845087
• Other study ID #: 2021-AQUALAB
• Status: Completed
• Phase: N/A
• Start date: April 24, 2021
• Est. completion date: July 8, 2021

Study information

• Verified date: July 2021
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to assess if ozonized water can be used for the treatment of peri-implant mucositis in patients with dental implants.

Patients willl undergo professional dental hygiene also with the use of glycine powders, then they will be randomly divided into two groups:

• Trial Group: irrigation of peri-implant periodontium with mucositis with ozonized water.

• Placebo Group: irrigation of peri-implant periodontium with mucositis with water.

Periodontal indices will be recorded at the baseline, after 1 and 2 months. After 1 and 2 months, only glycine powders will be performed, together with ozonized water or water irrigation and the collection of periodontal indices.

Description:

The aim of this study is to assess if ozonized water can be used for the treatment of peri-implant mucositis in patients with dental implants.

Patients who respond to eligibility criteria and that will sign the informed consent will undergo a professional oral hygiene procedure.

Patients willl undergo professional dental hygiene also with the use of glycine powders. Then, glycine powders air-flow will be administered. Then they will be randomly divided into two groups:

• Trial Group: irrigation of peri-implant periodontium with mucositis with ozonized water.

• Placebo Group: irrigation of peri-implant periodontium with mucositis with water.

Periodontal indices will be recorded at the baseline, after 1 and 2 months. After 1 and 2 months, only glycine powder will be performed, together with ozonized water/water irrigation and the collection of periodontal indices.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 8, 2021
• Est. primary completion date: July 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Presence of one or more dental implants

• Presence of peri-implant mucositis at least at one implant

• Bleeding Score > 0

Exclusion Criteria:

• Patents without dental implants

• Presence of systemic diseases

• Patients with cardiac pacemaker

Related Conditions & MeSH terms

• Mucositis
• Peri-implant Mucositis

Intervention

Other:
• Ozonized water
Irrigation of dental implants with ozonized water
• Placebo
Irrigation of dental implants with water

Locations

Country	Name	City	State
Italy	Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia	Pavia	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PPD - Probing Depth	Evaluation (in mm) of the depth of the gingival sulcus, through a millimeter periodontal probe; it is detected from the gingival margin to the bottom of the gingival sulcus of the peri-implant pocket, evaluated at 6 sites.	Baseline, 1 and 2 months.
Primary	Change in BOP - Bleeding on Probing (percentage)	Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PD, detected on 6 sites.	Baseline, 1 and 2 months.
Primary	Change in BS - Bleeding Score	Scoring criteria: 0: no bleeding; 1: punctiform bleeding in the site of probing; 2: bleeding within the gingival border; 3: bleeding outside the gingival border.	Baseline, 1 and 2 months.
Primary	Change in PI - Plaque Index (percentage)	Site-specific assessment of the presence or visible plaque detected on 4 sites with a disclosing tables.; Percentage of sites with plaque determines the PI%.	Baseline, 1 and 2 months.