Not provided
Not provided
Not provided
Not provided
Not provided
The study was terminated after interim data analysis
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Aarhus | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to assess the effect of enzyme containing lozenges on dental plaque accumulation in healthy adults.
The purpose of the study is to examine the clinical effects of lozenges containing three extracellular matrix-degrading enzymes on dental plaque accumulation and removal, prevention of gingivitis, and oral microbiome composition after professional tooth cleaning, as compared to a placebo lozenge without enzymes. Two different concentrations of the enzymes will be tested, to investigate a potential dose-dependent effect of the enzymes. Furthermore, safety of the enzyme lozenge will be assessed by clinical evaluation of the oral mucosa. The null hypothesis is that treatment with enzyme-containing lozenges does not affect plaque accumulation as compared to a placebo control.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enzyme lozenge 1 | Active Comparator | The lozenge contains three plaque extracellular matrix degrading enzymes |
|
| Enzyme lozenge 2 | Active Comparator | The concentration of the three enzymes in the "Enzyme lozenge 2" is threefold the enzyme concentration than in the "Enzyme lozenge 1" |
|
| Placebo lozenge | Placebo Comparator | The placebo lozenge contains the same ingredients except for the enzymes and has an identical taste, color and texture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enzyme lozenge 1 | Other | Participants are instructed to take one enzyme containing lozenge three times daily, at least 30 min after a meal, for 14 days. No normal oral hygiene procedures are allowed during the intervention period. |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque amount | Dental plaque accumulation after 1-day use of either a test or placebo investigational lozenge assessed by the Turesky modified Quingly-Hein Plaque Index (QHPI) (score 0-5, 0 being no plaque, 5 being entire tooth covered with plaque) | Change in QHPI score from baseline to 24 hours' follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque amount | Dental plaque accumulation after 7 and 14 days assessed by the Turesky modified Quingly-Hein Plaque Index (QHPI) (score 0-5, 0 being no plaque, 5 being entire tooth covered with plaque) | Change in QHPI score from baseline to Day 7 follow-up and from baseline to Day 14 follow-up |
| Gingivitis |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mette Rose Jørgensen, DDS, PhD | Novozymes A/S | Study Director |
| Sebastian Schlafer, DDS, PhD | Aarhus University, Department of Dentistry and Oral Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University, Department of Dentistry and Oral Health | Aarhus | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40676928 | Derived | Rikvold PD, Johnsen KK, Del Rey YC, Hansen LBS, Knap I, Holz C, Meyer RL, Jorgensen MR, Schlafer S. The Effect of Enzymes on Dental Plaque: A Randomized Controlled Trial. J Dent Res. 2026 Feb;105(2):236-244. doi: 10.1177/00220345251347959. Epub 2025 Jul 17. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003773 | Dental Plaque |
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Enzyme lozenge 2 | Other | Participants are instructed to take one lozenge with 3x higher enzyme concentration three times daily, at least 30 min after a meal, for 14 days. No normal oral hygiene procedures are allowed during the intervention period. |
|
| Placebo lozenge | Other | Participants are instructed to take one placebo lozenge three times daily, at least 30 min after a meal, for 14 days. No normal oral hygiene procedures are allowed during the intervention period. |
|
Development of gingivitis after 14 days assessed by the Gingival Index of Löe and Silness (GI) (score 0-3, 0 being no gingivitis, 3 being excessive gingivitis) |
| Change in GI from baseline to Day 14 follow-up |
| Plaque removal | Plaque removal by mechanical treatment with a water-/airpik. The technique will be applied professionally at the clinical site by co-investigator. | Day 14 visit |
| Oral microbiome | Oral microbiome composition | Change in microbiome composition from baseline to Day 14 follow-up |
| Plaque fluorescence intensity measurement | Dental plaque accumulation assessed by fluorescence intensity measurements, to provide information on the individual level of plaque formation. Soft biofilm on the teeth is calculated using an appropriate software program, compatible with the device used. | Change in intensity measurement from baseline to Day 7 follow-up and Day 14 follow-up |
| D005882 |
| Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |