NCT03649789

Brief Summary

Salivary gland hypofunction, or dry mouth, is a damaging oral condition that affects salivary gland production. Absence of saliva causes bad breath, dental decay, increased plaque accumulation, dry lips, mouth sores, and the inability to retain dentures or removable protheses. This study will determine if patients with dry mouth have different periodontal health than patients without dry mouth. Additionally, this study will examine if patients who have their periodontal maintenance appointments solely at a periodontal speciality clinic have different periodontal health than patients who alternate their appointments between a specialty office and their general dental office.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 28, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

8 months

First QC Date

July 19, 2018

Last Update Submit

December 27, 2019

Conditions

Periodontal PocketXerostomiaDry MouthPeriodontal Diseases

Keywords

healingbiomarkerssanative therapynutritional supplementsmedicationssalivary flow

Outcome Measures

Primary Outcomes (1)

  • Probing Depth

    Probing depth is a routine clinical measure of periodontal health (measured in mm)

    At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards

Secondary Outcomes (9)

  • Bleeding on Probing

    At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards

  • O'Leary Index of Plaque Control

    At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards

  • Gingival Index (used to assess gingival condition to distinguish between the quality of gingiva and the location of gingival concerns).

    At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards

  • Thickness of Periodontal Tissue

    At maintenance appointment (1 hour)

  • Body Mass Index (BMI)

    At maintenance appointment (1 hour)

  • +4 more secondary outcomes

Other Outcomes (4)

  • Furcations

    At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards

  • Tooth Mobility

    At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards

  • Salivary Markers of Inflammation

    At maintenance appointment (1 hour)

  • +1 more other outcomes

Study Arms (2)

No Salivary Gland Hypofunction

These individuals have an unstimulated salivary flow rate of greater than 0.1 mL saliva/min.

Salivary Gland Hypofunction

These individuals have an unstimulated salivary flow rate of less than 0.1 mL saliva/min.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients who previously underwent sanative therapy to manage periodontal disease at this clinic and who have regular maintenance periodontal cleanings on a regular basis at the clinic.

You may qualify if:

  • have had sanative therapy at this clinic in the previous 1 to 5 years.

You may not qualify if:

  • anyone who is unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery

Fonthill, Ontario, L0S1E5, Canada

Location

Brock University

St. Catharines, Ontario, L2S3A1, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva is being collected at time of hygiene appointment.

MeSH Terms

Conditions

Periodontal PocketXerostomiaPeriodontal Diseases

Condition Hierarchy (Ancestors)

PeriodontitisMouth DiseasesStomatognathic DiseasesSalivary Gland Diseases

Study Officials

  • Wendy E Ward, PhD

    Brock University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Canada Research Chair

Study Record Dates

First Submitted

July 19, 2018

First Posted

August 28, 2018

Study Start

August 1, 2018

Primary Completion

March 30, 2019

Study Completion

May 1, 2019

Last Updated

January 2, 2020

Record last verified: 2019-12

Locations

CA(2)