Periodontitis, Adult Clinical Trial
— GBT2017Official title:
Efficacy of Sub-gingival Air-polishing With Erythritol in the Treatment of Periodontitis
Verified date | February 2020 |
Source | Azienda Ospedaliera Spedali Civili di Brescia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The first step in the management of periodontal disease involves the non-surgical removal of
the soft and hard bacterial deposits at all supra- and sub-gingival sites, especially into
deep pockets, which can be carried on with different instruments. Unfortunately it seems
that, after the initial therapy, many patients still present with active pockets (residual
pockets) requiring further treatment and posing a risk of disease progression. This might be
due to limitations of the instruments applied and patient-related factors. Air-polishing with
low-abrasiveness powders seems to be very effective in the removal of supra- and sub-gingival
biofilm and could provide additional benefits during the treatment of pockets.
The hypothesis of the present randomized controlled trial was that the adjunctive use of a
sub-gingival nozzle for air-polishing with erythritol powder in pockets with probing depth of
5-9mm and with bleeding (experimental sites) can bring clinical and microbiological
advantages during the active therapy of periodontal disease, and reduce the number of
residual pockets.
To test this hypothesis, the patients, upon initial evaluation, were divided in 2 study
groups:
1. The control group, undergoing a standard procedure involving air-polishing
supra-gingivally and at healthy sub-gingival sites followed by debridement with an
ultrasonic scaler at deep pathological pockets
2. The study group, undergoing the same procedure but with the additional use of a
sub-gingival nozzle at deep pathological pockets.
The healing of the experimental sites and the prevalence of residual pockets will be
evaluated at 3 months after the initial therapy and compared between the two groups.
Status | Completed |
Enrollment | 40 |
Est. completion date | December 10, 2019 |
Est. primary completion date | October 5, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Signed Informed Consent Form. - Male and female subjects, aged 18-75 years, inclusive. - Good general health (free of systemic diseases such as diabetes, HIV infection or genetic disorder, ongoing malignant disease of any type that could influence the outcome of the treatment and might interfere with the evaluation of the study objectives). - Moderate to severe periodontitis - At least 8 experimental sites (PD 5-9 mm and BoP+). - Availability for the 3-month duration of the study for an assigned subject. Exclusion Criteria: - Presence of orthodontic appliances. - Chronic obstructive pulmonary disease and asthma. - Tumors or significant pathology of the soft or hard tissues of the oral cavity. - Current radiotherapy or chemotherapy. - Pregnant or lactating women. - Current or past (within 3 months prior to enrolment) assumption of medications that may influence periodontal conditions and/or interfere with healing following periodontal treatment (i.e., corticosteroids, calcium channel blockers, systemic antibiotics, ...). - History of allergy to Erythritol. - Restorations on the teeth to be treated which may interfere with treatment administration and/or scoring procedures, at the discretion of the examiner. - Non-surgical and/or surgical mechanical/manual periodontal debridement within 3 months prior to enrolment. - Use of systemically administered antibacterial agents to treat periodontal disease or dental prophylaxis within 3 months prior to enrolment. |
Country | Name | City | State |
---|---|---|---|
Italy | Magda Mensi | Brescia | Lombardia |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Spedali Civili di Brescia | Università degli Studi di Ferrara |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary outcome measure:3 month and to the end of study ( 1 years) | Sites characterized by PD 5-9 mm and BoP+ will be therefore identified as "experimental sites". | through study completion, an average of 1 year |
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