Periodontal Outcomes After Sanative Therapy

NCT ID: NCT03649789

Last Updated: 2020-01-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2019-05-01

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.

Detailed Description

Salivary gland hypofunction, or dry mouth, is a damaging oral condition that affects the function and flow rate of saliva. Low saliva rates can range from mild self-reported symptoms and discomfort to significant oral diseases. Saliva is essential in preventing irritation and friction of mucosal surfaces. Progressively dry mouth can cause oral and bodily conditions that can affect an individuals quality of life and daily tasks, such as eating and avoiding social situations. Specifically, dry mouth is a risk factor for periodontal disease, a chronic oral inflammation of tissues and ligaments that support the tooth's structure and if untreated, will ultimately lead to tooth loss. In Canada, the first line of defense against periodontal disease is non-surgical sanative therapy (ST). Participants in this study have been attending a periodontal specialty clinic for routine periodontal maintenance appointments for at least 1 to 5 years following their initial scaling and root planing. Salivary flow rate will be measured to determine the level of dry mouth. At the regular maintenance appointment, clinical measures will be evaluated (probing depth, bleeding on probing, plaque index, gingival index, thickness of tissues, mobility, and furcations). Patients will also complete a dry mouth questionnaire to determine if dry mouth influences the day to day life of a patient, and the patient's Registered Dental Hygienist will complete a short questionnaire outlining oral symptoms of dry mouth. Additionally, the investigators aim to see if a patient who has periodontal maintenance appointments at a specialty office has different clinical outcomes than a patient who alternates these appointments between a specialty office and a general dental office. Overall, the investigators will determine if thorough periodontal maintenance appointments are efficient in preventing periodontal disease in patients with dry mouth.

Conditions

Periodontal Pocket; Xerostomia; Dry Mouth; Periodontal Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

No Salivary Gland Hypofunction

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

No interventions assigned to this group

Salivary Gland Hypofunction

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• anyone who is unable to provide informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: collaborator

Brock University

OTHER

Sponsor Role: lead

Responsible Party

Wendy E. Ward, Ph.D.

Professor and Canada Research Chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wendy E Ward, PhD

Role: PRINCIPAL_INVESTIGATOR

Brock University

Locations

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

Fonthill, Ontario, Canada

Brock University

St. Catharines, Ontario, Canada

Countries

Canada

Other Identifiers

17-387-WARD

Identifier Type: -

Identifier Source: org_study_id