MucositisNCT03243591
Impact of Oral Hygiene Gels on Peri-implant Mucositis
A study testing Livionex gel and Aquafresh gel in people with Mucositis, run by University of Nebraska at 1 site in United States.
Trial summary
Peri-implant mucositis is abnormal inflammation occurring around dental implants, increasing the risk of loss of bone support. The purpose of this study is to evaluate the impact of brushing the bacterial biofilm at the implant-mucosa interface with one of two, commercially-available dental gels over a 30-day period… Read more about this study
- Who is it for?
- Ages 19 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Mucositis
- What is being tested?
- Livionex gel and Aquafresh gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2017to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- history of 5 mm+ pocket bleeding on probing around implant
Who cannot join
- dental treatment of implant in previous 30 days
- Sjogrens disease
- immunodeficiencies (e.g. AIDS)
- poorly-controlled diabetes
- regular use of antibiotics, anti-inflammatory drugs or immune suppressants
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center, College of Dentistry
Lincoln, Nebraska, 68583
About this study
Peri-implant mucositis is abnormal inflammation occurring around dental implants, increasing the risk of loss of bone support. The purpose of this study is to evaluate the impact of brushing the bacterial biofilm at the implant-mucosa interface with one of two, commercially-available dental gels over a 30-day period on amounts of biofilm and indices of mucosal inflammation. Adult subjects (> 19 years old) will be invited to consent if they have at least one dental implant displaying mucositis defined as Gingivitis Index of 2 or greater, no dental treatment in the previous 30 days, capable of normal toothbrushing, and no Sjogrens disease, immunodeficiency, pregnancy, poorly-controlled diabetes, or regular systemic antibiotics, anti-inflammatory drugs or immune suppressants. Ten patients in each tooth gel group will be instructed to apply a pea size amount of dentifrice brushing the implant and mucosa 2 times daily for 30 days. Baseline and 30-day examinations will be conducted to record Gingivitis Index, Plaque Index, probing depths, clinical photo, crevicular fluid, and adverse events.
Read the detailed description
This will be a prospective, randomized, controlled, double-blind, single center study. Once eligibility has been determined, up to 21 Subjects will be enrolled. Subjects will be randomly assigned in a 1:1 ratio to treat with either Livionex Dental Gel (a plaque control gel that is safe for ingestion and is currently sold by Livionex Inc.) or the control Aquafresh toothpaste. Each study visit will last 30 minutes.
The soft tissue around the dental implant will be observed at baseline and after 30 days for inflammation using the Gingivitis Index and probed with a UNC 15 periodontol probe for pocket depth and bleeding. A photograph will be taken of the most inflamed side of the implant. Plaque will be stained with oral hygiene staining rinse and evaluated for Plaque Index. Finally, a paper strip will be inserted between the gingiva and implant on facial and lingual sides for 30 seconds each.
GINGIVITIS INDEX: Gingivitis score (GI)= Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation slight change in color and little change in texture 2 = Moderate inflammation moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding. GI scored=sum of GI scores divided by the number of sites (gingival gum line around the tooth) scored.
PLAQUE INDEX Using Quigley Staining Hein Method with Turesky Modification:Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth. Plaque score = sum of all scores divided by the number of sites (teeth) scored.
Each patients will be instructed to brush around the implant with a pea size amount of dentifrice provided, twice daily for 30 days.
- Conditions
- Mucositis
- Being tested
- Livionex gel, Aquafresh gel
- Medical subject headings
- Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Livionex gelOther
Also called Aquafresh gel
Brushing area of mucositis with gel
Aquafresh gelOther
Aquafresh gel
| Study group | Role | What they receive |
|---|---|---|
| Livionex gel | Active comparator | Brushing area of mucositis with Livionex gel for 30 days Receives: Other: Livionex gel |
| Aquafresh gel | Active comparator | Brushing area of mucositis with Aquafresh gel for 30 days Receives: Other: Aquafresh gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Index
Level of clinical inflammation around dental implant
Measured: 30 days
Secondary outcomes (2)
Plaque Index
Amount of biofilm around dental implant
Measured: 30 days
Crevicular Fluid Biomarkers
Fluid from around implant measured for inflammation markers with ELISA
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start22 Aug 2017
- Primary completion15 Mar 2018
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MucositisStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized, controlled, double-blind, single center
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard A Reinhardt, DDS, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243591
- Sponsor's protocol ID
- 0388-17-EP
- Status last verified
- Sep 2023
- First submitted
- 4 Aug 2017
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Oral Hygiene Gels on Peri-implant Mucositis
- ClinicalTrials.gov ID
- NCT03243591
- Acronym / sponsor ID
- 0388-17-EP
- Conditions
- Mucositis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 22 Aug 2017 (actual)
- Primary completion
- 15 Mar 2018 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 9 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Peri-implant mucositis is abnormal inflammation occurring around dental implants, increasing the risk of loss of bone support. The purpose of this study is to evaluate the impact of brushing the bacterial biofilm at the implant-mucosa interface with one of two, commercially-available dental gels over a 30-day period on amounts of biofilm and indices of mucosal inflammation. Adult subjects (> 19 years old) will be invited to consent if they have at least one dental implant displaying mucositis defined as Gingivitis Index of 2 or greater, no dental treatment in the previous 30 days, capable of normal toothbrushing, and no Sjogrens disease, immunodeficiency, pregnancy, poorly-controlled diabetes, or regular systemic antibiotics, anti-inflammatory drugs or immune suppressants. Ten patients in each tooth gel group will be instructed to apply a pea size amount of dentifrice brushing the implant and mucosa 2 times daily for 30 days. Baseline and 30-day examinations will be conducted to record Gingivitis Index, Plaque Index, probing depths, clinical photo, crevicular fluid, and adverse events.
Detailed description
This will be a prospective, randomized, controlled, double-blind, single center study. Once eligibility has been determined, up to 21 Subjects will be enrolled. Subjects will be randomly assigned in a 1:1 ratio to treat with either Livionex Dental Gel (a plaque control gel that is safe for ingestion and is currently sold by Livionex Inc.) or the control Aquafresh toothpaste. Each study visit will last 30 minutes.
The soft tissue around the dental implant will be observed at baseline and after 30 days for inflammation using the Gingivitis Index and probed with a UNC 15 periodontol probe for pocket depth and bleeding. A photograph will be taken of the most inflamed side of the implant. Plaque will be stained with oral hygiene staining rinse and evaluated for Plaque Index. Finally, a paper strip will be inserted between the gingiva and implant on facial and lingual sides for 30 seconds each.
GINGIVITIS INDEX: Gingivitis score (GI)= Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation slight change in color and little change in texture 2 = Moderate inflammation moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding. GI scored=sum of GI scores divided by the number of sites (gingival gum line around the tooth) scored.
PLAQUE INDEX Using Quigley Staining Hein Method with Turesky Modification:Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth. Plaque score = sum of all scores divided by the number of sites (teeth) scored.
Each patients will be instructed to brush around the implant with a pea size amount of dentifrice provided, twice daily for 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, randomized, controlled, double-blind, single center
| Arm | Type | Receives |
|---|---|---|
| Livionex gel | Active comparator | Other: Livionex gelBrushing area of mucositis with Livionex gel for 30 days |
| Aquafresh gel | Active comparator | Other: Aquafresh gelBrushing area of mucositis with Aquafresh gel for 30 days |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- history of 5 mm+ pocket bleeding on probing around implant
Key exclusion criteria (5 listed)
- dental treatment of implant in previous 30 days
- Sjogrens disease
- immunodeficiencies (e.g. AIDS)
- poorly-controlled diabetes
- regular use of antibiotics, anti-inflammatory drugs or immune suppressants
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 |
|---|---|---|
| Livionex gelAlso: Aquafresh gelBrushing area of mucositis with gel | Other | Livionex gel |
| Aquafresh gelAquafresh gel | Other | Aquafresh gel |
Primary outcome
Gingival Index
Time frame: 30 days
Level of clinical inflammation around dental implant
2 secondary outcomes
Plaque Index
Time frame: 30 days
Crevicular Fluid Biomarkers
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Richard A Reinhardt, DDS principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Livionex gel and Aquafresh gel in people with Mucositis, run by University of Nebraska at 1 site in United States.
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 1 inclusion and 5 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 26 Sep 2023. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Gingival Index (time frame: 30 days). 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 26 Sep 2023.