Trial · NCT02647203
Non-invasive Treatment of Root Caries in Older Adults
NCT02647203, Phase 1, Phase 2, Completed, University of Talca; results first posted 2021-01-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Non-invasive Treatment of Root Caries in Older Adults. Trials, record NCT02647203. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02647203
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Non-invasive Treatment of Root Caries in Older Adults
- NCT number
- NCT02647203
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 345 participants, actual
- Lead sponsor
- University of Talca
- Conditions
- Root Caries
- Interventions
- Self-administered fluoridated dentifrices
- First posted
- 2016-01-06
- Last updated
- 2024-01-02
- Results first posted
- 2021-01-05
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Root Caries Activity | After 2 years of follow up | Using Nyvad's criteria for root caries lesions, activity will be assessed by a visual-tactile method. |
| Secondary | Oral Health Related Quality of Life, Measured by the Oral Health Impact Profile (OHIP-14 Sp) | Data registered at 2 years of follow-up | The impact on the quality of life of the therapy will be explored using the OHIP-14 Sp, validated by our group. In a scale ranging from 0 to 56 points, with 0-14 being good Oral Health-related quality of life and 15-56 poor Oral Health-related quality of life. |
| Secondary | Salivary Flow | Baseline and 2-year follow up | Unstimulated Salivary Flow, defined as Normal or Low Important: This outcome measure was originally considered. However, due to logistic issues, we did not assess it and no data is available. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Root Caries Activity | After 2 years of follow up | Independently-living older adults | Percentage of active lesions (2-years) | MEAN |
| SECONDARY | Oral Health Related Quality of Life, Measured by the Oral Health Impact Profile (OHIP-14 Sp) | Data registered at 2 years of follow-up | Independently-living older adults | score on a scale | MEAN |
| SECONDARY | Salivary Flow | Baseline and 2-year follow up |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Root Caries Activity | High Fluoride Toothpaste | 3.72 | Standard Deviation 12.32 | Percentage of active lesions (2-years) | |
| Root Caries Activity | Standard Fluoride Toothpaste | 40.52 | Standard Deviation 23.30 | Percentage of active lesions (2-years) | |
| Oral Health Related Quality of Life, Measured by the Oral Health Impact Profile (OHIP-14 Sp) | High Fluoride Toothpaste | 10.71 | Standard Deviation 9.56 | score on a scale | |
| Oral Health Related Quality of Life, Measured by the Oral Health Impact Profile (OHIP-14 Sp) | Standard Fluoride Toothpaste | 11.28 | Standard Deviation 9.25 | score on a scale |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 12 Month Follow-up | STARTED | High Fluoride Toothpaste | 173 | |
| 12 Month Follow-up | STARTED | Standard Fluoride Toothpaste | 172 | |
| 12 Month Follow-up | COMPLETED | High Fluoride Toothpaste | 148 | |
| 12 Month Follow-up | COMPLETED | Standard Fluoride Toothpaste | 149 | |
| 12 Month Follow-up | NOT COMPLETED | High Fluoride Toothpaste | 25 | |
| 12 Month Follow-up | NOT COMPLETED | Standard Fluoride Toothpaste | 23 | |
| 24 Month Follow-up | STARTED | High Fluoride Toothpaste | 148 | |
| 24 Month Follow-up | STARTED | Standard Fluoride Toothpaste | 149 | |
| 24 Month Follow-up | COMPLETED | High Fluoride Toothpaste | 142 | |
| 24 Month Follow-up | COMPLETED | Standard Fluoride Toothpaste | 138 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | High Fluoride Toothpaste | 0 | 142 |
| Total, all-cause mortality | Standard Fluoride Toothpaste | 0 | 138 |
| Total, other adverse events | High Fluoride Toothpaste | 0 | 142 |
| Total, other adverse events | Standard Fluoride Toothpaste | 0 | 138 |
| Total, serious adverse events | High Fluoride Toothpaste | 0 | 142 |
| Total, serious adverse events | Standard Fluoride Toothpaste | 0 | 138 |
Source ClinicalTrials.gov
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| High Fluoride Toothpaste vs Standard Fluoride Toothpaste: deaths from any cause | Trial comparisons |
| High Fluoride Toothpaste vs Standard Fluoride Toothpaste: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02647203
GET https://conductscience.org/api/trials/v1/NCT02647203/registered