Clinical trial NCT04455269: The Efficacy of Full Mouth Erythritol Powder Air-Polishing Therapy (FM-EPAPT) Versus Traditional Ultrasonic Debridment (UD): a Randomized Controlled Study.
Official title: The Efficacy of Full Mouth Erythritol Powder Air-Polishing Therapy (FM-EPAPT) Versus Traditional Ultrasonic Debridment (UD): a Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Keywords: Gingivitis
GBT
Ultrasonic debridement
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 41
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Mono-centric, double-blinded, randomized clinical trial (RCT) with a split-mouth design.
Primary purpose: TREATMENT

Brief summary: Traditional methods for plaque and calculus removal involve the use of mechanical and/or manual instruments, followed by surface polishing with rubber cups and low abrasive pastes. These instruments may cause the unintended removal of hard dental tissue, such as enamel, cementum and dentine, increasing surface roughness. Moreover, they can lead to gingival recession and consequent hypersensitivity and discomfort during treatment. New minimally-invasive approaches to biofilm removal have been recently introduced with the aim to limit the negative impact on the oral tissue. Air-polishing with low-abrasiveness powders are proven suitable for both for supra- and sub-gingival plaque removal. The use of low-abrasiveness powders could lead to several advantages, such as reduction of treatment discomfort, shorter treatment time, the possibility of cleaning areas with difficult access and minor damage on soft and hard tissues.

Aim: the aim of this study is to evaluate the efficacy of the Full Mouth Erithrytol Powder Air-Polishing Therapy compared to traditional ultrasonic debridment (UD) and polishing in patient affected by gingivitis.

Test hypotesis: there is no difference in clinical outcome between two methods against the hypothesis of a difference in terms of changes in Blending on Probing (BOP).

To test this hypothesis, the patients, upon initial evaluation, were treated in split mouth:

* The control group undergoing the standard procedure with full-mouth ultrasonic debridement and polishing with rubber cup and abrasive paste.
* The study group undergoing an innovative procedure involving full-mouth air-polishing followed by ultrasonic calculus removal.

Follow-ups are scheduled at 2 weeks and 1, 3, 6 and 12 months.

Detailed description: TRIAL DESIGN:

Mono-centric, pragmatic, double-blinded, randomized clinical trial (RCT) with split-mouth design. The trial will have a one year of duration.

PRIMARY OUTCOME:

- Change in BoP: change in percentage of sites positive to bleeding on probing.

SECONDARY OUTCOMES:

* Change in Plaque Index (PI): change in percentage of sites with presence of plaque. Baseline values will be compared to the values recorded at follow-up visits.
* Change in Residual Plaque Area (RPA): Post-treatment percentage of tooth area with residual plaque, visualised via plaque disclosing agent. This will be calculated with computer software analysis (ImageJ) on clinical photographs.
* Change in Periodontal Attachment Level (PAL): change in mean value for each patient will be calculated. Baseline values will be compared to the values recorded at follow-up visits.
* Change in (Pocket Probing Depth) PPD: change in mean value for each patient will be calculated. Baseline values will be compared to the values recorded at follow-up visits.
* Duration of the treatment: calculated in minutes. Time will be recorded starting from the opening the randomisation envelope until the clinician is satisfied with the clinical result.
* Comfort of the patient: an anonymous questionnaire will be administered at baseline and each recall appointment.
* Sensation of cleanliness: an anonymous questionnaire will be administered at baseline and each recall appointment.

STUDY POPULATION:

41 Systemically healthy patients affected by gingivitis will be included in this study. Presence of gingivitis is defined as: absence of Probing pocket depth (PPD) \> 4mm and presence of BoP \>25%.

INCLUSION CRITERIA:

* Patients affected by gingivitis (BoP \>25%);
* Patients with at least 5 teeth per quadrant;
* Systemically healthy;
* Age \> 18 years;
* Smoking less than 10 cigarettes a day.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of gingivitis (BoP \> 25%);
* Presence of at least 5 teeth per quadrant;
* Systemically healthy;
* Age between 20 and 40 years old.

Exclusion Criteria:

* Presence of periodontal disease, defined as \>3 mm of clinical attachment loss at any site;
* Presence of fixed retainers, orthodontic appliances or complex prothetic restorations;
* Presence of crowding;
* Pregnant or lactating;
* Allergy to chlorhexidine or erythritol;
* Smoking \>10 cigarettes per day;
* Unwillingness to undergo the proposed treatment and recalls;

Primary outcomes:
measure: Change in Bleeding on Probing (BoP)
timeFrame: study completion, an average of 18 months
Secondary outcomes:
measure: Change in Plaque Index (PI)
timeFrame: From baseline to study completion (12 months)
measure: Change in residual plaque area (RPA)
timeFrame: From baseline to study completion (12 months)
measure: Change in Periodontal Attachment Level (PAL)
timeFrame: From baseline to study completion (12 months)
measure: Change in Pocket Probing Depth (PPD)
timeFrame: From baseline to study completion (12 months)
measure: Treatment time
timeFrame: From baseline to study completion (12 months)
measure: Comfort of the patient
timeFrame: From baseline to study completion (12 months)
measure: Sensation of cleanliness
timeFrame: From baseline to study completion (12 months)
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Magda Mensi
state: Lombardia
Study officials:
affiliation: ASST Spedali Civili di Brescia
name: Magda Mensi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Draenert ME, Jakob M, Kunzelmann KH, Hickel R. The prevalence of tooth hypersensitivity following periodontal therapy with special reference to root scaling. A systematic review of the literature. Am J Dent. 2013 Feb;26(1):21-7.
citation: Buhler J, Amato M, Weiger R, Walter C. A systematic review on the patient perception of periodontal treatment using air polishing devices. Int J Dent Hyg. 2016 Feb;14(1):4-14. doi: 10.1111/idh.12119. Epub 2015 Jan 23.
citation: Flemmig TF, Arushanov D, Daubert D, Rothen M, Mueller G, Leroux BG. Randomized controlled trial assessing efficacy and safety of glycine powder air polishing in moderate-to-deep periodontal pockets. J Periodontol. 2012 Apr;83(4):444-52. doi: 10.1902/jop.2011.110367. Epub 2011 Aug 23.
citation: Camboni S, Donnet M. Tooth Surface Comparison after Air Polishing and Rubber Cup: A Scanning Electron Microscopy Study. J Clin Dent. 2016 Mar;27(1):13-18.
citation: Kim SY, Kang MK, Kang SM, Kim HE. Effects of ultrasonic instrumentation on enamel surfaces with various defects. Int J Dent Hyg. 2018 May;16(2):219-224. doi: 10.1111/idh.12339. Epub 2018 Mar 13.