NCT04462341

Brief Summary

This study is designed to evaluate the effectiveness of cleaning around implants that hold a full denture in the mouth. Different oral hygiene protocols will be compared. Areas to measure are gum tissue color and consistency, bleeding and cleanliness. A questionnaire will be provided at the end of the study. This is a proof of concept study.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

August 27, 2021

Status Verified

July 1, 2020

Enrollment Period

2.4 years

First QC Date

July 2, 2020

Last Update Submit

August 25, 2021

Conditions

Peri-implant Mucositis

Outcome Measures

Primary Outcomes (1)

  • Bleeding on probing

    Binary

    6 weeks

Secondary Outcomes (1)

  • Probing depth

    6 weeks

Study Arms (2)

Manual brushing only

ACTIVE COMPARATOR

Participants brushed with a manual toothbrush and fluoridated toothpaste twice a day for 6 weeks

Device: Manual Toothbrush

Manual brushing + water flossing

EXPERIMENTAL

Participants brush twice a day and water flossed once a day for 6 weeks.

Device: Water FlosserDevice: Manual Toothbrush

Interventions

Water FlosserDEVICE

Device that uses water under pressure to clean around teeth and under the gums

Manual brushing + water flossing
Manual ToothbrushDEVICE

Plastic handle with nylon bristles to clean teeth

Manual brushing + water flossingManual brushing only

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • have a maxillary and/or mandibular implant supported, removable complete denture that is supported by at least 2 implants in good, serviceable condition
  • Good general health, with no diseases which could impact periodontal health
  • able to read and understand English
  • willing to return for all appointments
  • at least 30% BOP
  • probing depths less or equal to 5mm

You may not qualify if:

  • subjects who are currently pregnant
  • mobility of implant
  • subjects who have diabetes
  • subjects who smoke
  • subjects with any serious medical condition which the investigator feels may impact participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tufts School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location

Study Officials

  • Gerard Kugel, DDS

    Tufts School of Dental Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2020

First Posted

July 8, 2020

Study Start

January 7, 2019

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

August 27, 2021

Record last verified: 2020-07

Locations

US(1)