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.O.U. Città della Salute e della Scienza

Status: Enrolling

Conditions: Plaque, Dental

Treatments: Procedure: Glycine Perio Flow; Behavioral: Standard Domiciliary Oral Hygiene; Behavioral: Angled Toothbrush; Procedure: Standard Professional Oral Hygiene

Study type: Interventional

Funder types: Other

Identifiers

NCT05965076

99110619

Details and patient eligibility

About

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.

Enrollment: 74 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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74 participants in 4 patient groups

Standard

Active Comparator group

Description:

Patients will be professionally treated with standard dental hygiene treatment, and they will use a standard toothbrush for their domiciliary oral hygiene.

Treatment:

Procedure: Standard Professional Oral Hygiene

Behavioral: Standard Domiciliary Oral Hygiene

Glycine

Experimental group

Description:

Patients will be professionally treated by adding glycine perio-flow in the treatment, and they will use a standard toothbrush for their domiciliary oral hygiene.

Treatment:

Behavioral: Standard Domiciliary Oral Hygiene

Procedure: Glycine Perio Flow

Angled toothbrush

Experimental group

Description:

Patients will be professionally treated with standard dental hygiene treatment, and they will use an angled toothbrush for their domiciliary oral hygiene.

Treatment:

Procedure: Standard Professional Oral Hygiene

Behavioral: Angled Toothbrush

Glycine - Angled toothbrush

Experimental group

Description:

Patients will be professionally treated by adding glycine perio-flow in the treatment, and they will use an angled toothbrush for their domiciliary oral hygiene.

Treatment:

Behavioral: Angled Toothbrush

Procedure: Glycine Perio Flow