Effects of Prebiotic Oral Healthcare Products as an Adjunct to Non-surgical Periodontal Therapy

NCT02520375 | Withdrawn

• 1 other identifier: s58074
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to determine the impact of a prebiotic toothpaste and mouthrinse in periodontitis patients as an adjunct to scaling and rootplaning.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

• Pocket Probing Depth (PPD) at teeth with residual pockets

  Pocket probing depth measured with Merrit B prob

  Baseline - 6 months

Study Arms (2)

Prebiotic

EXPERIMENTAL

This group will be administered a prebiotic mouthrinse and toothpaste

Other: Prebiotic

Control

PLACEBO COMPARATOR

This group will be administered a control mouthrinse and toothpaste

Other: Control

Interventions

Prebiotic OTHER

Prebiotic

Control OTHER

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients
• ≥ 36 years of age
• \- Page 4 of 4 \[DRAFT\] -
• No previous scaling and rootplaning
• Clinical diagnosis: severe generalized periodontitis characterized by the presence of \> 14 affected teeth when \> 14 teeth are present (if number of teeth present is \< 14, 8-14 teeth need to be affected) with an attachment loss of \> 6mm prior to initial non-surgical periodontal therapy.
• A minimum of 3 natural teeth in every quadrant
• Willing and able to give written informed consent

You may not qualify if:

• Patients with aggressive periodontitis or necrotizing periodontitis
• Patients who smoke
• Pregnant or lactating woman
• A history of diabetes, rheumatic fever, liver or kidney disease, neurological deficiencies, or use of medication which may affect periodontal tissue, (phenytoin, cyclosporin, nifedipine, chronic use of non-steroidal antiinflammatory drugs)
• Patients with poorly controlled diabetes
• Patients taking bisphosphonate mediation
• Patient who have taken systemic antibiotics 3 months prior to treatment

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

MeSH Terms

Conditions

Periodontitis

Interventions

Prebiotics

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2015
• First Posted: August 11, 2015
• Primary Completion: December 1, 2017
• Last Updated: March 14, 2017

Record last verified: 2017-03