Clinical trial NCT04845087: Management of Peri-implant Mucositis With Ozone Water Jet: a Randomized Clinical Trial.
Official title: Pilot Study for the Management of Peri-implant Mucositis With Ozone Water Jet: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-implant Mucositis
Keywords: ozonized water
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2021-04-14
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in PPD - Probing Depth
timeFrame: Baseline, 1 and 2 months.
measure: Change in BOP - Bleeding on Probing (percentage)
timeFrame: Baseline, 1 and 2 months.
measure: Change in BS - Bleeding Score
timeFrame: Baseline, 1 and 2 months.
measure: Change in PI - Plaque Index (percentage)
timeFrame: Baseline, 1 and 2 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
state: Lombardy
Study officials:
affiliation: University of Pavia
name: Andrea Scribante, DDS, PhD.
role: PRINCIPAL_INVESTIGATOR
References: