Erythritol Air Polishing in Mucositis Treatment
ConditionPeri-implant Mucositis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Coimbra
About this trial
This study aimed to evaluate the effectiveness of air polishing systems compared to the exclusive use of oral hygiene instruction in the treatment of peri-implant mucositis
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults with at least one implant in function for a minimum of one year affected by peri-implant mucositis.
Disqualifiers
Pregnant or lactating women
patients unable to understand the treatment protocol and sign informed consent and/or patients younger than 18 years old,
medical conditions that prevents an oral examination,
incapability to perform oral hygiene measures due to physical or mental disorders,
Trial design
Design model
Parallel
Treatments tested in this trial
Air-polishing with erythritol at different time points
Procedure/SurgeryThe air-polishing device will be inserted into each site of the peri-implant pocket at an angle ranging from 60 to 90 degrees, and each surface will be debrided for 5 seconds using erythritol powder (AIRFLOW Powder PERIO; EMS). In this group this procedure will be done ate baseline, 1 month and 2 months
Single Air-polishing with erythritol
Procedure/SurgeryThe air-polishing device will be inserted into each site of the peri-implant pocket at an angle ranging from 60 to 90 degrees, and each surface will be debrided for 5 seconds using erythritol powder (AIRFLOW Powder PERIO; EMS). In this group this procedure will be done ate baseline only.
Treatment groups
24 Participants
are divided into 3 treatment groupsGroup A: Test Group Erythritol Monthly ApplicationsExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Group C: Test Group Erythritol Single ApplicationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Changes in Bleeding on Probing compared to baseline
Bleeding on Probing (BoP) will be evaluated according to the modified bleeding index (0-no BoP; 1- punctiform drop of bleed; 2- confluent red continuous line formed through the sulcus; 3-heavy/profuse), for each site
Time frame
Baseline, 3 months and 6 monthsSecondary outcomes
1
Probing Pocket Depth
Measured in mm from the mucosal margin to most apical point of the pocket
Time frame
Baseline, 3 months and 6 months2
Plaque index (PI)
assessed dichotomously as the presence or absence of plaque along the mucosal/gingival margin
Time frame
Baseline, 3 months and 6 months3
Gingival Recession
Distance, measured in mm from the cementoenamel junction to the gingival margin
Time frame
Baseline, 3 months and 6 months4
Radiographic bone level
calculated as the difference between the marginal bone levels assessed at follow-up visits and the ones assessed in the baseline
Time frame
Baseline, 3 months and 6 monthsSponsors and contacts
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Source ClinicalTrials.gov