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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-06

Study Completion Date

2024-12-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Plaque, Dental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard

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

Group Type ACTIVE_COMPARATOR

Standard Professional Oral Hygiene

Intervention Type PROCEDURE

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

Standard Domiciliary Oral Hygiene

Intervention Type BEHAVIORAL

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

Glycine

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.

Group Type EXPERIMENTAL

Glycine Perio Flow

Intervention Type PROCEDURE

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

Standard Domiciliary Oral Hygiene

Intervention Type BEHAVIORAL

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

Angled toothbrush

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

Group Type EXPERIMENTAL

Angled Toothbrush

Intervention Type 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

Intervention Type PROCEDURE

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

Glycine - Angled toothbrush

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.

Group Type EXPERIMENTAL

Glycine Perio Flow

Intervention Type PROCEDURE

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

Angled Toothbrush

Intervention Type BEHAVIORAL

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

Interventions

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Glycine Perio Flow

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

Intervention Type PROCEDURE

Angled Toothbrush

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

Intervention Type BEHAVIORAL

Standard Professional Oral Hygiene

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

Intervention Type PROCEDURE

Standard Domiciliary Oral Hygiene

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes