MucositisPhase 3implantitisNCT01072201
To Access the Effects of Mucositis in Adults With Dental Implants
A Phase 3 study testing Triclosan and Fluoride and Fluoride in people with Mucositis, run by Colgate Palmolive at 1 site in Italy.
Trial summary
Clinical research for the treatment of mucositis subjects who have dental implants for a minimum of one-year. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Mucositis
- What is being tested?
- Triclosan and Fluoride and Fluoride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2007to Dec 2007
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects, ages 30-70.
- Availability for the six-month duration of the clinical research study.
- Good general health.
- Subjects who have lost teeth for periodontal disease reasons and who have been restored with implants.
- Minimum of 5 remaining teeth and a minimum of 2 implants.
- Initial evaluation of the gingival and peri-implant mucosal tissues by determining full mouth bleeding on probing.
- Initial plaque evaluation by determining full mouth presence/absence of plaque.
- Signed Informed Consent Form.
Who cannot join
- Tumor(s) of the soft or hard tissues of the oral cavity.
- Untreated periodontal disease (purulent exudate, tooth mobility, and/or extensive loss or periodontal attachment or alveolar bone).
- Carious lesions requiring immediate restorative treatment.
- Uncontrolled Diabetes
- Use of antibiotics any time during the one month prior to entry into the study.
- Untreated peri-implantitis.
Show all 13Show fewer
- Participation in any other clinical research study or test panel within the three months prior to entry into the study.
- Pregnant women or women who are breast feeding.
- History of allergies to personal care/consumer products or their ingredients.
- Medical condition which prohibits not eating/drinking for up to 2 hours.
- Current alcohol or drug abuse.
- Systemic or local disease conditions that would compromise post-operative healing.
- Regular use of anti-inflammatory drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Clinical research for the treatment of mucositis subjects who have dental implants for a minimum of one-year.
- Conditions
- Mucositis
- Being tested
- Triclosan and Fluoride, Fluoride
- Medical subject headings
- Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triclosan and FluorideDrug
Also called Total Toothpaste
Brush twice daily
FluorideDrug
Also called Ultrabrite toothpaste
Brush twice daily
| Study group | Role | What they receive |
|---|---|---|
| Total toothpaste | Experimental | Triclosan/copolymer/fluoride toothpaste Receives: Drug: Triclosan and Fluoride |
| Ultrabrite toothpaste | Placebo comparator | Fluoride Toothpaste Receives: Drug: Fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on Probing
Percentage of Bleeding Scale: The bleeding sites are identified by either a 0 or 1. (0=no bleeding \& 1= bleeding) The number of spots between teeth that bleed are divided by number of spots between teeth that are scored.
Measured: 6 months
Mean Pocket Depth
Measurement scale: 0 millimeter measurement= no pocket depth. 3, 4, 5, \& 6 millimeter are indications of deeper Pocket depth.
Measured: 6 Months
Mean Percentage of Plaque Scores
Mean Percentage (%) of dental plaque on all tooth surfaces, including implants and natural teeth. Plaque Scale is 0=no plaque and 1= dental plaque present. Percentage is derived from sum of all plaque scores divided by the number of tooth surfaces scored.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startJun 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MucositisStudies of the same condition, open and under way.
- More trials run by Colgate PalmoliveThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Per Ramberg, DDS, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01072201
- Sponsor's protocol ID
- CRO-0107-PERIO-MUC-ITA-PC
- Acronym
- implantitis
- Status last verified
- Sep 2010
- First submitted
- 26 Sep 2008
- Last updated
- 5 Oct 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Access the Effects of Mucositis in Adults With Dental Implants
- ClinicalTrials.gov ID
- NCT01072201
- Acronym / sponsor ID
- implantitis / CRO-0107-PERIO-MUC-ITA-PC
- Conditions
- Mucositis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 19 Feb 2010 (estimated)
- Results
- Posted 19 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical research for the treatment of mucositis subjects who have dental implants for a minimum of one-year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total toothpaste | Experimental | Drug: Triclosan and FluorideTriclosan/copolymer/fluoride toothpaste |
| Ultrabrite toothpaste | Placebo comparator | Drug: FluorideFluoride Toothpaste |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female subjects, ages 30-70.
- Availability for the six-month duration of the clinical research study.
- Good general health.
- Subjects who have lost teeth for periodontal disease reasons and who have been restored with implants.
- Minimum of 5 remaining teeth and a minimum of 2 implants.
Key exclusion criteria (13 listed)
- Tumor(s) of the soft or hard tissues of the oral cavity.
- Untreated periodontal disease (purulent exudate, tooth mobility, and/or extensive loss or periodontal attachment or alveolar bone).
- Carious lesions requiring immediate restorative treatment.
- Uncontrolled Diabetes
- Use of antibiotics any time during the one month prior to entry into the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triclosan and FluorideAlso: Total ToothpasteBrush twice daily | Drug | Total toothpaste |
| FluorideAlso: Ultrabrite toothpasteBrush twice daily | Drug | Ultrabrite toothpaste |
Primary outcome
Bleeding on Probing
Time frame: 6 months
Percentage of Bleeding Scale: The bleeding sites are identified by either a 0 or 1. (0=no bleeding \& 1= bleeding) The number of spots between teeth that bleed are divided by number of spots between teeth that are scored.
Mean Pocket Depth
Time frame: 6 Months
Measurement scale: 0 millimeter measurement= no pocket depth. 3, 4, 5, \& 6 millimeter are indications of deeper Pocket depth.
Mean Percentage of Plaque Scores
Time frame: 6 Months
Mean Percentage (%) of dental plaque on all tooth surfaces, including implants and natural teeth. Plaque Scale is 0=no plaque and 1= dental plaque present. Percentage is derived from sum of all plaque scores divided by the number of tooth surfaces scored.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Ramberg, DDS principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Triclosan and Fluoride and Fluoride in people with Mucositis, run by Colgate Palmolive at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding on Probing (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2010.