Analysis of the Effectiveness of the Use of Glycine Powder and Angled Implant Brush in Oral Hygiene Maintenance in Patients Reinstated With Columbus Bridge ProtocolTM

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorA.O.U. Città della Salute e della Scienza

About this trial

This study aims at comparing different procedures of Professional Oral Hygiene (POH) and Domiciliary Oral Hygiene (DOH) in Columbus Bridge ProtocolTM full-arch reinstated patients by dividing a sample of at least 74 patients into 4 groups with a 1:1:1:1 ratio. The patients will randomly be assigned to a "Standard" or "Glycine Perio Flow" Professional treatment, and to a "Standard" or "Angled" Toothbrush for their Domiciliary oral hygiene.

Data about bacterial plaque presence is collected both before and after unscrewing the denture, when it comes to implant abutments. Instead, Denture Plaque Index will be collected after unscrewing the denture, by means of erythrosine and analyzed using a specific software that allows to compute the percentage of plaque on the denture.

Patients will be seen after 3 months in order to figure out differences between DOH groups, by measuring plaque on abutments and on the denture after unscrewing it.

At the moment there are no scientific studies trying to determine which professional and domiciliary procedures might be more efficient to control bacterial plaque in Columbus Bridge ProtocolTM reinstated patients.

Statistically significant lower Plaque Index (PI) and Denture Plaque Index (DPI) scores are expected in patients treated with glycine perio flow, compared to standard treated patients. However, when it comes to angled toothbrush, lower PI and DPI are expected not to be statistically significant.

Expectation from this study is to get information on how to improve full-arch patients' therapy in order to reduce peri-implant diseases which are related to bacterial plaque.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age >= 18years

Good systemic health, with ASA classification <= 2

Columbus Bridge ProtocolTM reinstation from at least six months

Disqualifiers

Heavy smokers (>= 10 cigarettes per day)

Pregnancy or breastfeeding

Autoimmune diseases with or without oral involvement

Biological complications on at least one of the dental implants

Trial design

Design model

Factorial

Treatments tested in this trial

  • Glycine Perio Flow

    Procedure/Surgery

    Professional plaque and tartar removal by means of titanium curettes, bridge and implant floss and glycine perio-flow.

  • Angled Toothbrush

    Behavioral

    Patients will be educated and motivated in domiciliary oral hygien by means of bridge and implant floss and an angled toothbrush.

  • Standard Professional Oral Hygiene

    Procedure/Surgery

    Professional plaque and tartar removal by means of titanium curettes, bridge and implant floss.

  • Standard Domiciliary Oral Hygiene

    Behavioral

    Patients will be educated and motivated in domiciliary oral hygien by means of bridge and implant floss and a standard toothbrush.

Treatment groups

74 Participants
are divided into 4 treatment groups
Group A: StandardActive comparator 2 interventions
Group B: GlycineExperimental treatment 2 interventions
Group C: Angled toothbrushExperimental treatment 2 interventions
Group D: Glycine - Angled toothbrushExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Denture Plaque Index (DPI)

This study's primary outcome is the plaque index on the denture (DPI). Plaque indexes will be determined by means of erythrosine (GC Tri Plaque ID GelTM, Tokyo, Japan). Pictures in jpg format will be taken with a digital Nikon D80 camera with 105mm macro lens and processed with ImageJ 1.45s software (National Institutes of Health, Bethesda, MD, USA). Pictures will be converted into binary monochrome images. Specific standard thresholds will be determined to differentiate the plaque pixels (blue) from the plaque free ones (pink). This procedure is already proven by literature.

Time frame
T0: first session (for professional oral hygiene).
2

Denture Plaque Index (DPI)

This study's primary outcome is the plaque index on the denture (DPI). Plaque indexes will be determined by means of erythrosine (GC Tri Plaque ID GelTM, Tokyo, Japan). Pictures in jpg format will be taken with a digital Nikon D80 camera with 105mm macro lens and processed with ImageJ 1.45s software (National Institutes of Health, Bethesda, MD, USA). Pictures will be converted into binary monochrome images. Specific standard thresholds will be determined to differentiate the plaque pixels (blue) from the plaque free ones (pink). This procedure is already proven by literature.

Time frame
T1: second session, after 3 months (for domiciliary oral hygiene).

Secondary outcomes

1

Probing Depth (PD);

Periodontal indexes will be determined on four areas for each implant by means of a UNC 15 (Hu-Friedy, Chicago, IL, USA) Probe. Probing depth is evaluated in mm.

Time frame
T0: first session (for professional oral hygiene).
2

Probing Depth (PD);

Periodontal indexes will be determined on four areas for each implant by means of a UNC 15 (Hu-Friedy, Chicago, IL, USA) Probe. Probing depth is evaluated in mm.

Time frame
T1: second session, after 3 months (for domiciliary oral hygiene).
3

Bleeding on Probing (BoP);

Periodontal indexes will be determined on four areas for each implant by means of a UNC 15 (Hu-Friedy, Chicago, IL, USA) Probe. Bleeding on probing is evaluated as presence of bleeding (yes/no).

Time frame
T0: first session (for professional oral hygiene).
4

Bleeding on Probing (BoP);

Periodontal indexes will be determined on four areas for each implant by means of a UNC 15 (Hu-Friedy, Chicago, IL, USA) Probe. Bleeding on probing is evaluated as presence of bleeding (yes/no).

Time frame
T1: second session, after 3 months (for domiciliary oral hygiene).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.