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NCT Number: 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

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.

Recruiting

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Key information

Conditions

Plaque, Dental Dental Deposits Dental Plaque Stomatognathic Diseases Tooth Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glycine Perio Flow

Procedure

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

Angled Toothbrush

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

Procedure

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

Standard Domiciliary Oral Hygiene

Behavioral

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

Primary outcomes

  1. Denture Plaque Index (DPI)

    Time frame: 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.

  2. Denture Plaque Index (DPI)

    Time frame: T1: second session, after 3 months (for domiciliary 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 outcomes

  1. Probing Depth (PD);

    Time frame: 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.

  2. Probing Depth (PD);

    Time frame: T1: second session, after 3 months (for domiciliary 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.

  3. Bleeding on Probing (BoP);

    Time frame: 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).

  4. Bleeding on Probing (BoP);

    Time frame: T1: second session, after 3 months (for domiciliary 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).

  5. Plaque Index on implant abutments

    Time frame: 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. PI is defined as plaque presence (yes/no) on the abutment or denture by means of erythrosine gel.

  6. Plaque Index on implant abutments

    Time frame: T1: second session, after 3 months (for domiciliary 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Armando Crupi, Dr.

CONTACT

[email protected]

+39 0116331531

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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: a Factorial Randomized Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 28, 2023
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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