Actively Recruiting

Phase Not Applicable
All Genders
Healthy Volunteers
NCT05965076

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

Led by A.O.U. Città della Salute e della Scienza · Updated on 2024-07-23

74

Participants Needed

1

Research Sites

96 weeks

Total Duration

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AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age >= 18 years
  • Good overall health with ASA classification <= 2
  • Columbus Bridge ProtocolTM full-arch restoration placed at least six months ago
Not Eligible

You will not qualify if you...

  • Heavy smoking (10 or more cigarettes per day)
  • Pregnancy or breastfeeding
  • Autoimmune diseases with or without oral involvement
  • Biological complications on any dental implant
  • Diagnosis of peri-implantitis as defined by Lindhe et al's criteria
  • Radicular bone less than 4 mm as seen on X-ray
  • Use of drugs that cause gingival overgrowth
  • Cognitive or motor impairments
  • Full-arch restorations done at other centers
  • Respiratory problems
  • Infectious diseases

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

S.C. Riabilitazione Orale Protesi Maxillo-Facciale e Implantologia Dentaria

Torino, Italy, 10126

Actively Recruiting

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Research Team

A

Armando Crupi, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

PREVENTION

Number of Arms

4

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