Actively Recruiting

Phase Not Applicable
All Genders
Healthy Volunteers
ID05965076

Effectiveness of Glycine Powder and Angled Toothbrush in Oral Hygiene for Columbus Bridge ProtocolTM Full-Arch Patients: A Randomized Factorial Study

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

74

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating different professional and home oral hygiene methods to control bacterial plaque in patients with full-arch dental restorations using the Columbus Bridge ProtocolTM. This study randomly assigns at least 74 patients into four groups to compare standard versus glycine perio-flow professional treatments and standard versus angled toothbrushes for home care. The goal is to find the best way to reduce plaque and potentially lower the risk of peri-implant diseases in these patients. Participants receive either standard dental cleaning or cleaning with added glycine powder professionally. For home care, they use either a standard or an angled toothbrush, combined with flossing. The study groups include all combinations of these treatments. Treatments and evaluations occur at the start and again after three months to assess differences in plaque levels. During the study, plaque on implant abutments and dentures is measured both before and after removing dentures. Denture plaque is analyzed using a special dye and software to calculate plaque percentage. Additional measures like probing depth and bleeding on probing are recorded at the start and after three months. Patients’ oral hygiene is monitored, and outcomes focus on plaque reduction to improve full-arch dental care. The total study includes an initial session and a follow-up visit three months later.

CONDITIONS

Brief 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 �3e= 18 years
  • Good systemic health with ASA classification �3c= 2
  • Columbus Bridge ProtocolTM full-arch restoration for at least six months
Not Eligible

You will not qualify if you...

  • Heavy smokers (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 4mm as evaluated by X-ray
  • Use of drugs causing gingival overgrowth
  • Cognitive or motor impairments
  • Full-arch restorations performed elsewhere
  • Respiratory issues
  • Infective diseases

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 3 months

Participants receive professional oral hygiene treatment including either standard care or glycine perio-flow, and use either a standard or angled toothbrush for domiciliary oral hygiene.

2 visits (in-person): initial professional oral hygiene session and follow-up session after 3 months

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.

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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Published Research Related To This Trial

Peri-implant diseases: Consensus Report of the Sixth European Workshop on Periodontology.

Jan Lindhe, Joerg Meyle, Group D of European Workshop on Periodontology

https://pubmed.ncbi.nlm.nih.gov/18724855