GingivitisNCT01236950
Study of an Essential Oil and a Delmopinol Mouthrinse Effect on Dental Plaque Accumulation Index, Gingivitis Index and on Streptococcus Mutans, Lactobacillus, Aerobic and Anaerobic Oral Bacteria Colony Counts.
A study testing Essential oils mouthrinse and Delmopinol mouthrinse in people with Gingivitis and Dental Plaque Accumulation, run by University of Lisbon at 1 site in Portugal.
Trial summary
The use of mouthrinses may be of relevance as a complement to daily dental hygiene procedures, especially for patients who do not comply with a proper mechanical removal of dental plaque. Essential oils and delmopinol mouthrinses are effective to reduce dental plaque accumulation and gingivitis. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Dental Plaque Accumulation
- What is being tested?
- Essential oils mouthrinse and Delmopinol mouthrinse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePortugal
- Study dates
- Apr 2007to Sep 2008
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patient at the dental hygiene clinic of Faculdade de Medicina Dentária
- Signature of consent form
- Have, at least, two quadrant with 6 teeth each
- Gingival Index at baseline less than 3
- Presence of dental plaque
Who cannot join
- Use of a mouthrinse
- Dental Hygiene appointment in the past 6 months
- Use of antibiotics in teh past 3 months
- Presence of extensive caries and fractures of teeth
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Faculdade de Medicina Dentária da Universidade de Lisboa
Lisbon, Lisbon District, 1649-003
About this study
The use of mouthrinses may be of relevance as a complement to daily dental hygiene procedures, especially for patients who do not comply with a proper mechanical removal of dental plaque. Essential oils and delmopinol mouthrinses are effective to reduce dental plaque accumulation and gingivitis. Also an effect on dental bacteria can be found. The study hypothesis states that there are no differences between the mouthrinses on the reduction of gingivitis and dental plaque accumulation as well on the bacterial counts of Streptococcus mutans, Lactobacillus, aerobic and anaerobic bacteria.
- Conditions
- Gingivitis, Dental Plaque Accumulation
- Being tested
- Essential oils mouthrinse, Delmopinol mouthrinse
- Keywords
- Clinical Trial, Prevention Mouthrinse
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essential oils mouthrinseDrug
Also called Listerine Cool Mint
Commercial mouthrinse with manufacturer's use indication
Delmopinol mouthrinseDrug
Also called Decapinol
Commercial mouthrinse with manufacturer's use indication
| Study group | Role | What they receive |
|---|---|---|
| Delmopinol mouthrinse | Experimental | Subjects use the delmopinol mouthrinse Receives: Drug: Delmopinol mouthrinse |
| Control | No intervention | Subjects with no use of mouthrinse |
| Essential oils mouthrinse | Experimental | Subjects using the essential oils mouthrinse Receives: Drug: Essential oils mouthrinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loe & Silness Gingival Index (1963)
data collected at the begining of the study and two weeks after mouthrinse usage.
Measured: change from baseline in gingival index at two weeks
Quigley, Hein & Turesky Dental Plaque Index (1970)
data collected at the begining of the study and two weeks after mouthrinse usage.
Measured: change from baseline in plaque index at two weeks
Secondary outcomes (3)
Streptococcus mutans CFU
data collected at the begining of the study and two weeks after mouthrinse usage.
Measured: change from baseline in CFU counts at two weeks
Lactobacillus CFU
data collected at the begining of the study and two weeks after mouthrinse usage.
Measured: change from baseline in CFU counts at two weeks
Aerobic and anaerobic oral bacteria CFU
data collected at the begining of the study and two weeks after mouthrinse usage.
Measured: change from baseline in CFU counts at two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startApr 2007
- Primary completionApr 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lisbon
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Piaget
- Investigators
- Mario F Bernardo, PhD, Study director, Faculdade de Medicina Dentária da Universidade de Lisboa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236950
- Sponsor's protocol ID
- 9/2006a
- Status last verified
- Jul 2010
- First submitted
- 8 Nov 2010
- Last updated
- 10 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Abbott DM, Gunsolley JC, Koertge TE, Payne EL. The relative efficacy of 0.1% and 0.2% delmopinol mouthrinses in inhibiting the development of supragingival dental plaque and gingivitis in man. J Periodontol. 1994 May;65(5):437-41. doi: 10.1902/jop.1994.65.5.437.
PubMed 8046559Addy M, Moran J, Newcombe RG. Meta-analyses of studies of 0.2% delmopinol mouth rinse as an adjunct to gingival health and plaque control measures. J Clin Periodontol. 2007 Jan;34(1):58-65. doi: 10.1111/j.1600-051X.2006.01013.x. Epub 2006 Nov 20.
PubMed 17116159Baehni PC, Takeuchi Y. Anti-plaque agents in the prevention of biofilm-associated oral diseases. Oral Dis. 2003;9 Suppl 1:23-9. doi: 10.1034/j.1601-0825.9.s1.5.x.
PubMed 12974527Barnett ML. The rationale for the daily use of an antimicrobial mouthrinse. J Am Dent Assoc. 2006 Nov;137 Suppl:16S-21S. doi: 10.14219/jada.archive.2006.0408.
PubMed 17035671Fine DH, Furgang D, Barnett ML, Drew C, Steinberg L, Charles CH, Vincent JW. Effect of an essential oil-containing antiseptic mouthrinse on plaque and salivary Streptococcus mutans levels. J Clin Periodontol. 2000 Mar;27(3):157-61. doi: 10.1034/j.1600-051x.2000.027003157.x.
PubMed 10743861Gordon JM, Lamster IB, Seiger MC. Efficacy of Listerine antiseptic in inhibiting the development of plaque and gingivitis. J Clin Periodontol. 1985 Sep;12(8):697-704. doi: 10.1111/j.1600-051x.1985.tb00941.x.
PubMed 3902908Ouhayoun JP. Penetrating the plaque biofilm: impact of essential oil mouthwash. J Clin Periodontol. 2003;30 Suppl 5:10-2. doi: 10.1034/j.1600-051x.30.s5.4.x.
PubMed 12787196
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of an Essential Oil and a Delmopinol Mouthrinse Effect on Dental Plaque Accumulation Index, Gingivitis Index and on Streptococcus Mutans, Lactobacillus, Aerobic and Anaerobic Oral Bacteria Colony Counts.
- ClinicalTrials.gov ID
- NCT01236950
- Acronym / sponsor ID
- 9/2006a
- Conditions
- Gingivitis, Dental Plaque Accumulation
- Keywords
- Clinical Trial, Prevention Mouthrinse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of LisbonUniversity, hospital or other
- Collaborators
- Instituto Piaget
- Study start
- Apr 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 9 Nov 2010 (estimated)
- 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.
The use of mouthrinses may be of relevance as a complement to daily dental hygiene procedures, especially for patients who do not comply with a proper mechanical removal of dental plaque. Essential oils and delmopinol mouthrinses are effective to reduce dental plaque accumulation and gingivitis. Also an effect on dental bacteria can be found. The study hypothesis states that there are no differences between the mouthrinses on the reduction of gingivitis and dental plaque accumulation as well on the bacterial counts of Streptococcus mutans, Lactobacillus, aerobic and anaerobic bacteria.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Delmopinol mouthrinse | Experimental | Drug: Delmopinol mouthrinseSubjects use the delmopinol mouthrinse |
| Control | No intervention | –Subjects with no use of mouthrinse |
| Essential oils mouthrinse | Experimental | Drug: Essential oils mouthrinseSubjects using the essential oils mouthrinse |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patient at the dental hygiene clinic of Faculdade de Medicina Dentária
- Signature of consent form
- Have, at least, two quadrant with 6 teeth each
- Gingival Index at baseline less than 3
- Presence of dental plaque
Key exclusion criteria (4 listed)
- Use of a mouthrinse
- Dental Hygiene appointment in the past 6 months
- Use of antibiotics in teh past 3 months
- Presence of extensive caries and fractures of teeth
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 |
|---|---|---|
| Essential oils mouthrinseAlso: Listerine Cool MintCommercial mouthrinse with manufacturer's use indication | Drug | Essential oils mouthrinse |
| Delmopinol mouthrinseAlso: DecapinolCommercial mouthrinse with manufacturer's use indication | Drug | Delmopinol mouthrinse |
Primary outcome
Loe & Silness Gingival Index (1963)
Time frame: change from baseline in gingival index at two weeks
data collected at the begining of the study and two weeks after mouthrinse usage.
Quigley, Hein & Turesky Dental Plaque Index (1970)
Time frame: change from baseline in plaque index at two weeks
data collected at the begining of the study and two weeks after mouthrinse usage.
3 secondary outcomes
Streptococcus mutans CFU
Time frame: change from baseline in CFU counts at two weeks
Lactobacillus CFU
Time frame: change from baseline in CFU counts at two weeks
Aerobic and anaerobic oral bacteria CFU
Time frame: change from baseline in CFU counts at two weeks
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 10 Nov 2010.
- Background: PubMed 8046559Abbott DM, Gunsolley JC, Koertge TE, Payne EL. The relative efficacy of 0.1% and 0.2% delmopinol mouthrinses in inhibiting the development of supragingival dental plaque and gingivitis in man. J Periodontol. 1994 May;65(5):437-41. doi: 10.1902/jop.1994.65.5.437.
- Background: PubMed 17116159Addy M, Moran J, Newcombe RG. Meta-analyses of studies of 0.2% delmopinol mouth rinse as an adjunct to gingival health and plaque control measures. J Clin Periodontol. 2007 Jan;34(1):58-65. doi: 10.1111/j.1600-051X.2006.01013.x. Epub 2006 Nov 20.
- Background: PubMed 12974527Baehni PC, Takeuchi Y. Anti-plaque agents in the prevention of biofilm-associated oral diseases. Oral Dis. 2003;9 Suppl 1:23-9. doi: 10.1034/j.1601-0825.9.s1.5.x.
- Background: PubMed 17035671Barnett ML. The rationale for the daily use of an antimicrobial mouthrinse. J Am Dent Assoc. 2006 Nov;137 Suppl:16S-21S. doi: 10.14219/jada.archive.2006.0408.
- Background: PubMed 10743861Fine DH, Furgang D, Barnett ML, Drew C, Steinberg L, Charles CH, Vincent JW. Effect of an essential oil-containing antiseptic mouthrinse on plaque and salivary Streptococcus mutans levels. J Clin Periodontol. 2000 Mar;27(3):157-61. doi: 10.1034/j.1600-051x.2000.027003157.x.
- Background: PubMed 3902908Gordon JM, Lamster IB, Seiger MC. Efficacy of Listerine antiseptic in inhibiting the development of plaque and gingivitis. J Clin Periodontol. 1985 Sep;12(8):697-704. doi: 10.1111/j.1600-051x.1985.tb00941.x.
- Background: PubMed 12787196Ouhayoun JP. Penetrating the plaque biofilm: impact of essential oil mouthwash. J Clin Periodontol. 2003;30 Suppl 5:10-2. doi: 10.1034/j.1600-051x.30.s5.4.x.
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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.
Mario F Bernardo, PhD study director
Faculdade de Medicina Dentária da Universidade de Lisboa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Essential oils mouthrinse and Delmopinol mouthrinse in people with Gingivitis and Dental Plaque Accumulation, run by University of Lisbon at 1 site in Portugal.
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 5 inclusion and 4 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 10 Nov 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 Portugal. 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?
Loe & Silness Gingival Index (1963) (time frame: change from baseline in gingival index at two weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01236950, which also lists 7 linked publications.
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 10 Nov 2010.