Effect of Enzymes on Dental Biofilm Accumulation

NCT05579938 | Completed DMC

• 1 other identifier: 2022-NZ-03
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Double-blind, placebo-controlled, cross-over study investigating dental biofilm accumulation after 4-days in 28 subjects randomised to receive: Sequence 1: 5 active enzyme-containing lozenges per day for 4-days followed by a 2-week washout period followed by 5 identical placebo lozenges per day for 4-days or Sequence 2: 5 placebo lozenges per day for 4-days followed by a 2-week washout period followed by 5 identical active enzyme lozenges per day for 4-days

Conditions

Dental Plaque

Keywords

Enzymes; Dental biofilm; Dental plaque

Outcome Measures

Primary Outcomes (1)

• 4-day biofilm accumulation in the absence of oral mechanical hygiene

  Biofilm accumulation is assessed by the Lobene-Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index (PLI)

  4-day biofilm accumulation from Baseline following dental prophylaxis (score of 0) to Day 4

Secondary Outcomes (1)

• 24-hour biofilm accumulation in the absence of oral mechanical hygiene

  24-hour biofilm accumulation from Baseline following dental prophylaxis (score of 0) to 24-hours

Other Outcomes (4)

• Abundance of salivary and plaque S. mutans

  4-days (Baseline to Day 4) for each crossover period

• Shift in detected plaque and saliva bacterial species of interest

  4-days (Baseline to Day 4) for each crossover period

• Change in inflammatory markers from Baseline to Day 4

  4-days (Baseline to Day 4)

Study Arms (2)

Verum Lozenges

ACTIVE COMPARATOR

Active enzyme-containing lozenges to be consumed 5 times per day for 4 days

Dietary Supplement: Enzyme-containing lozenge

Identical Placebo Lozenges

PLACEBO COMPARATOR

Placebo lozenges to be consumed 5 times per day for 4 days

Dietary Supplement: Placebo lozenge

Interventions

Enzyme-containing lozenge DIETARY_SUPPLEMENT

A lozenge containing 3 active enzymes

Verum Lozenges

Placebo lozenge DIETARY_SUPPLEMENT

Identical placebo lozenge

Identical Placebo Lozenges

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Generally healthy males and females 18-75 years of age.
• Able to read, sign and receive a copy of the signed informed consent form.
• Have at least 20 natural teeth with scorable facial and lingual surfaces. A scorable tooth is defined as having at least 2/3 of the natural tooth surface evaluable for the selected clinical measurements. The following will not be included in the scorable tooth count: third molars; teeth that are fully crowned/extensively restored, grossly carious, orthodontically banded/bonded or abutment teeth; teeth exhibiting general cervical abrasion and/or enamel abrasion and calculus deposits which, in the opinion of the clinical examiner, would interfere with the assessments)..
• Willing to refrain from all oral hygiene 8-12 hours prior to Screening visit.
• Willing to refrain from use of chewing gum over the course of the 4-day intervention periods
• At the Screening Visit, subject presents with:
• a. A plaque index score ≥ 1.95 according to the Lobene-Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index, following 8 to 12 hours plaque accumulation period.
• Willing and able to comply with scheduled visits, treatment plan and other study procedures.
• Willing to refrain from all oral hygiene (with the exception of lozenge consumption 5 times per day) for a 96-hour (4-day) period between Visits 2-4/Visits 5-7
• Willing to refrain from the use of chemotherapeutic antiplaque/antigingivitis products containing antibacterial agents such as, but not limited to, amine fluoride, chlorhexidine, stannous fluoride, essential oils, cetylpyridinium chloride, etc. and other oral hygiene products during the study.

You may not qualify if:

• A subject with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the subject inappropriate for entry into this study.
• Subject self-reported as currently pregnant, or breastfeeding or subject intends to become pregnant through the duration of the study.
• Uncontrolled diabetes or hypertension.
• Health condition requirement for antibiotic premedication prior to dental procedures.
• Current history of antibiotic, anti-inflammatory, anti-coagulant medication or chemotherapeutic antiplaque/antigingivitis therapy within 30 days of Screening visit.
• Subject is a smoker or user of smokeless tobacco, nicotine containing products (including chewing gum, patches, pouches or mints).
• Subject has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
• Presence of moderate or severe periodontal disease (Stage II, III or IV), or actively under treatment for periodontal disease.
• Presence of orthodontic appliances, peri/oral piercings, or removable partial dentures.
• History of allergy or significant adverse events following use of oral hygiene products such as toothpastes, mouth rinses, breath mints, lozenges, or chewing gum or their ingredients.
• A subject with high levels of extrinsic stain, calculus deposits or severely inflamed tissues which might interfere with dental plaque assessments.
• Have significant intra-oral soft tissue lesions due to pathology or trauma based on a visual examination.

Sponsors & Collaborators

• Novozymes A/S: lead

Study Sites (1)

Salus Research Inc

Fort Wayne, Indiana, 46825, United States

Location

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Jeffery L Milleman, DDS, MPA

  Salus Research Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 14, 2022
• Study Start: September 19, 2022
• Primary Completion: October 19, 2022
• Study Completion: November 20, 2022
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)