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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

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: a Factorial Randomized Study

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05965076
Enrollment
74
Registered
2023-07-28
Start date
2023-02-06
Completion date
2024-12-15
Last updated
2024-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque, Dental

Keywords

glycine, airflow, full-arch, angled toothbrush

Brief summary

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.

Interventions

PROCEDUREGlycine Perio Flow

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

BEHAVIORALAngled Toothbrush

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

PROCEDUREStandard Professional Oral Hygiene

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

BEHAVIORALStandard Domiciliary Oral Hygiene

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

Sponsors

A.O.U. Città della Salute e della Scienza
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Age \>= 18years * Good systemic health, with ASA classification \<= 2 * Columbus Bridge ProtocolTM reinstation from at least six months

Exclusion criteria

* 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 * Perimplantits diagnosis, defined according to Lindhe et al's criteria \[5\] * Radicular bone \<4mm, evaluated by means of RX * Use of gingival overgrowth inducing drugs * Cognitive or motor impairments * Full-arch reinstations performed in other structures * Respiratory issues * Infective diseases

Design outcomes

Primary

MeasureTime frameDescription
Denture Plaque Index (DPI)T0: first session (for professional oral hygiene).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.

Secondary

MeasureTime frameDescription
Probing Depth (PD);T0: first session (for professional oral hygiene).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.
Bleeding on Probing (BoP);T0: first session (for professional oral hygiene).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).
Plaque Index on implant abutmentsT0: first session (for professional oral hygiene).Periodontal indexes will be determined on four areas for each implant by means of a UNC 15 (Hu-Friedy, Chicago, IL, USA) Probe. PI is defined as plaque presence (yes/no) on the abutment or denture by means of erythrosine gel.

Countries

Italy

Contacts

Primary ContactArmando Crupi, Dr.
armando.crupi@unito.it+39 0116331531

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026