PeriodontitisNCT04692246
Effect of Essential Oils as Adjutants on the Treatment of Subjects With Periodontitis: Assessment of Metabolic Variables as Effect Modifiers
A study testing Plant-based oral rinse in people with Periodontitis, run by Universidad de Granada at 1 site in Spain.
Trial summary
Periodontitis, an infectious disease that affects the tooth-supporting tissues and shows a wide range of clinical, microbiological, and immunological manifestations, is associated with and probably caused by dynamic interaction among infectious agents, host immune responses, hazardous environmental exposure and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis
- What is being tested?
- Plant-based oral rinse
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2019to 1 Mar 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients attended in the University of Granada School of Dentistry (Granada, Spain)
- Accepting to be enrolled in the study and signing of a written consent.
Who cannot join
- Age under 18 years,
- Received periodontal treatment in the last year,
- Anti-microbial therapy in the previous 3 months
- Allergies
- Multiple pregnancy
- Presence of neoplastic or severe infectious diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Periodontitis, an infectious disease that affects the tooth-supporting tissues and shows a wide range of clinical, microbiological, and immunological manifestations, is associated with and probably caused by dynamic interaction among infectious agents, host immune responses, hazardous environmental exposure and genetic propensity. Bacteria are necessary for the disease to appear, but are not sufficient and do not account for all cases of periodontitis. According to one survey in the USA, chronic periodontitis affects approximately 46% of the adult population, with an even higher prevalence among the elderly. This prevalence refers to the cohort of young adults according to the WHO, with ages ranging from 35 to 44 years. Forms of periodontitis that appear at younger ages (before the age of 30 years), and that have other characteristics in addition to age, are known as aggressive periodontitis. The prevalence of this disorder ranges from 0.2% in Caucasians to 2.6% in Afro-Americans. The microbiota of the human oral mucosa together with other anatomical locations in the body constitute the human microbiome. The equilibrium between these organisms and the host response plays a fundamental role in human biology, both in health maintenance and in the appearance of disease. Unfavorable alterations in the composition of the microbiota are termed dysbiosis.
Antiseptics and antibiotics such as Chlorhexidine or Metronidazole, are delivered locally as an adjunct to scaling and root planing procedures, in order to eradicate the subgingival microbes, hence creating a healthy subgingival environment. However, the results presented in the literature are inconclusive. There is a need for further clinical trials with strict methodological criteria for allowing a more precise assessment of the efficacy of local antimicrobials in the treatment of chronic periodontitis.
Read more
Recently, there has been renewed interest in the application of natural products. Several natural products and herbs have claimed to have better properties and less side effects than chemical agents for irrigation. The use of natural extracts and essential oils as an irrigation agent for ultrasonic instrumentation has shown to promote slight adjunctive effect compared to chlorhexidine or water. In other study, natural extract showed a greater improvement compared to controls in patients with a more severe degree of periodontitis. However, in other studies this pocket reduction and clinical attachment gain were no significant when compared to water. Natural products have also been tested in forms of oral spray, and have shown to be effective against common oral pathogens without significant cytotoxicity in an in vitro study. Thus, it has the potential to prevent the infections and may serve as adjunctive treatment to conventional therapy. They claim to have the same or even more anti-microbial effect and anti-inflammatory effect without adding any chemicals. But still there is no adequate scientific evidence to support this hypothesis.
This study aims to test the effect as an adjutant to therapy of a nutraceutical composed of several plant extracts in patients with periodontitis and different levels of risk for metabolic syndrome. Specifically:
- The response of periodontal clinical variables to non-surgical periodontal treatment in patients treated with the extract, compared to controls.
- The effect on local inflammatory markers, in patients treated with the extract compared to controls.
- The modifier effect of metabolic syndrome-related variables in the treatment outcomes of the patients treated with the extract compared to controls.
Hypothesis:
The application of the plant extract would act as an anti-inflammatory agent, contributing to better treatment outcomes of periodontitis, in terms of clinical and biochemical variables.
Read the detailed description
METHODOLOGY
Study design Randomized, controlled, double-blinded clinical trial.
Study unit/population Subjects with diagnosis of periodontitis according to the joint EFP/AAP 2018 criteria for the case definition of periodontitis.
Inclusion criteria Patients attended in the University of Granada School of Dentistry (Granada, Spain) Signing of a written consent.
Exclusion criteria Age under 18 years, received periodontal treatment in the last year, anti-microbial therapy in the previous 3 months, multiple pregnancy and the presence of neoplastic or severe infectious diseases.
Sampling and randomization It is estimated to explore at least 60 patients, of which 30 will be randomized to each group, accordingly to similar studies on the topic available in the literature. The group allocation will also follow similar studies published previously in the field (7-9, 12, 13). All patients will receive standard periodontal treatment with an ultrasonic new generation device (AIRFLOW® Prophylaxis Master, EMS Dental, Nyon, Switzerland), and the group division will be based on the use of the extract as an adjunct to non-surgical treatment.
Test group: Patients that will receive the application of the extract in form of irrigation solutions in the periodontal pockets during regular periodontal treatment. Patients would continue at home during the follow-up period, taking the essential oils in as a rinse twice per day, and as a spray when regular toothbrush could not be performed.
Control group: Patients that will follow the same protocol, but using regular irrigation and a placebo spray at home.
The researchers that will perform the clinical examinations will be blinded for the group allocation of the participants, since the random allocation and prescription will be performed by a different researcher. Study products and placebo will be provided previously by the company BIONAP.
Study variables
- Sociodemographic variables: sex, age, smoking habit (cigs/day), alcohol consumption (g/day).
- Periodontal clinical variables: Periodontal examination will be performed by a calibrated researcher using PCPUNC15 periodontal probe (Hu-friedy, Chicago, IL, USA) and dental exploration mirror. Six surfaces in each implant will be measured: mesiovestibular, vestibular, distovestibular, distolingual, lingual, mesiolingual. All clinical data will be recorded in a periodontal chart. Clinical data will be gathered at baseline, and at 2 and 6 months of follow-up. Bleeding on probing: The percentage of bleeding implants while probing, will the registered following the index of Ainamo and Bay (14). Oral hygiene: Oral hygiene will be measured using the Plaque Index proposed by Tonetti (15). The presence of plaque will be registered by visual examination without using a plaque revealing agent.
- Metabolic syndrome-related variables:
- Body weight
- Body height
- Body mass index
- Waist circumference
- Blood pressure
- Biochemical variables:
Samples of saliva, subgingival plaque and gingival crevicular fluid will be obtained at the beginning of the study, at 2 months and at the end of follow-up. A panel of inflammatory cytokines will be assessed.
Blood samples will be obtained at the beginning of the study, at 2 months and at the end of follow-up for the assessment of:
- Fasting blood glucose
- Lipid profile (Total cholesterol, Triglycerides, LDL-cholesterol and HDL-cholesterol).
Data management and statistical analysis A database in Excel format will be prepared including all recorded variables. The data will be analyzed by a single researcher. The statistical software SPSS v.21.0 (IBM Inc., Chicago, IL, USA) will be used, performing descriptive statistics (means, standard deviations and percentages) and analytical procedures (95% confidence intervals, Mann-Whitney test, Chi-square, Student's t-test for paired samples, and univariate and multivariate regression analysis). A 5% significance level will be considered for all tests.
ETHICAL CONSIDERATIONS The study will be designed in order to comply with the standards of the las revision of the Helsinki declaration. Approval from the Research Ethics Committee in Human Studies of the University of Granada will be obtained prior to the beginning of the study. Written informed consent will be obtained from all participants in the study. All obtained data will be anonymous and the study will be designed following the CONSORT guidelines for reporting clinical trials (16).
WORK PLAN
The project has been planned to be performed in a period of 2 years:
- Study registration, ethical approval, and planning: December 2018 - February 2019.
- Study enrollment, allocation, samples and data gathering. Follow-up period: March 2019 - April 2020.
- Statistical analysis of all data: June 2020 - September 2020.
- Manuscript preparation and publication process: October 2020 - April 2021.
- Conditions
- Periodontitis
- Being tested
- Plant-based oral rinse, Placebo oral rinse
- Keywords
- Anti-inflammation, Nutraceuticals, Periodontal therapy, Periodontitis
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant-based oral rinseOther
Oral rinse enriched with plant-based essential oils.
Placebo oral rinseOther
Oral rinse with the exact characteristics in terms of colour and odour of the plant-based one, but without the essential oils aimed to test in this study
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Patients that will receive the application of the extract in form of irrigation solutions in the periodontal pockets during regular periodontal treatment. Patients would continue at home during the follow-up period, taking the essential oils in as a rinse twice per day, and as a spray when regular toothbrush could not be performed. Receives: Other: Plant-based oral rinse |
| Control Group | Placebo comparator | Patients that will follow the same protocol, but using placebo irrigation and a placebo spray at home. Receives: Other: Placebo oral rinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pocket probing depth
Depth of periodontal pockets present in the teeth of each patient in millimeters (mm) using a periodontal probe (PCPUNC-15)
Measured: Change from Baseline Pocket probing depth at 3 months
Pocket probing depth
Depth of periodontal pockets present in the teeth of each patient in millimeters (mm) using a periodontal probe (PCPUNC-15)
Measured: Change from Baseline Pocket probing depth at 6 months
Gingival recession
Distance from the gingival margin to the cemento-enamel junction in the teeth of each patient in millimeters (mm) using a periodontal probe (PCPUNC-15)
Measured: Change from Baseline Gingival recession at 3 months
Gingival recession
Distance from the gingival margin to the cemento-enamel junction in the teeth of each patient in millimeters (mm) using a periodontal probe (PCPUNC-15)
Measured: Change from Baseline Gingival recession at 6 months
Bleeding on probing
Percentage of teeth (%) that showed bleeding during periodontal examination.
Measured: Change from Baseline Bleeding on probing at 3 months
Bleeding on probing
Percentage of teeth (%) that showed bleeding during periodontal examination.
Measured: Change from Baseline Bleeding on probing at 6 months
Oral hygiene
Percentage of teeth surfaces (4 in each tooth) that showed visible plaque during periodontal examination (Visual Plaque Index).
Measured: Change from Baseline Visual Plaque Index at 3 months
Oral hygiene
Percentage of teeth surfaces (4 in each tooth) that showed visible plaque during periodontal examination (Visual Plaque Index).
Measured: Change from Baseline Visual Plaque Index at 6 months
Secondary outcomes (15)
Body weight
Weight of each patient in kilograms (Kg) with a body scale.
Measured: Change from Baseline Body weight at 3 months
Body weight
Weight of each patient in kilograms (Kg) with a body scale.
Measured: Change from Baseline Body weight at 6 months
Body height
Height of each patient in centimeters (cm) with a scale.
Measured: Baseline
Waist circumference
Waist abdominal circumference of each patient in centimeters (cm) with a measure tape.
Measured: Change from Baseline Waist circumference at 3 months
Waist circumference
Waist abdominal circumference of each patient in centimeters (cm) with a measure tape.
Measured: Change from Baseline Waist circumference at 6 months
Systolic Blood pressure
Systolic Blood pressure of each patient in Hg millimeters (Hg mm) measured with a sphygmomanometer.
Measured: Change from Baseline Systolic Blood pressure at 3 months
Systolic Blood pressure
Systolic Blood pressure of each patient in Hg millimeters (Hg mm) measured with a sphygmomanometer.
Measured: Change from Baseline Systolic Blood pressure at 6 months
Diastolic Blood pressure
Diastolic Blood pressure of each patient in Hg millimeters (Hg mm) measured with a sphygmomanometer.
Measured: Change from Baseline Diastolic Blood pressure at 3 months
Diastolic Blood pressure
Diastolic Blood pressure of each patient in Hg millimeters (Hg mm) measured with a sphygmomanometer.
Measured: Change from Baseline Diastolic Blood pressure at 6 months
Glycemia
Fasting glycemia of each patient in milligrams per deciliter (mg/dL) measured with a glucometer.
Measured: Change from Baseline Glycemia at 3 months
Glycemia
Fasting glycemia of each patient in milligrams per deciliter (mg/dL) measured with a glucometer.
Measured: Change from Baseline Glycemia at 6 months
Total cholesterol
Total cholesterol levels of each patient in mg/dL measured in serum samples.
Measured: Change from Baseline Total cholesterol at 6 months
Triglyceride
Triglyceride levels of each patient in mg/dL measured in serum samples.
Measured: Change from Baseline Triglyceride at 6 months
LDL-cholesterol
Low-density lipoprotein levels of each patient in mg/dL measured in serum samples.
Measured: Change from Baseline LDL-cholesterol at 6 months
HDL-cholesterol
High-density lipoprotein cholesterol levels of each patient in mg/dL measured in serum samples.
Measured: Change from Baseline HDL-cholesterol at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start1 Nov 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Why it stopped: Due to COVID-19 Pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- University of Palermo
- Responsible party
- Principal investigator, Francisco Mesa, Universidad de Granada
- Investigators
- Francisco Mesa, PhD, Principal investigator, Full Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692246
- Sponsor's protocol ID
- PON-FSE-2017-1
- Status last verified
- Dec 2020
- First submitted
- 22 Dec 2020
- Last updated
- 31 Dec 2020
- 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 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Essential Oils as Adjutants on the Treatment of Subjects With Periodontitis: Assessment of Metabolic Variables as Effect Modifiers
- ClinicalTrials.gov ID
- NCT04692246
- Acronym / sponsor ID
- PON-FSE-2017-1
- Conditions
- Periodontitis
- Keywords
- Anti-inflammation, Nutraceuticals, Periodontal therapy, Periodontitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to COVID-19 Pandemic
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- University of Palermo
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 31 Dec 2020 (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.
Periodontitis, an infectious disease that affects the tooth-supporting tissues and shows a wide range of clinical, microbiological, and immunological manifestations, is associated with and probably caused by dynamic interaction among infectious agents, host immune responses, hazardous environmental exposure and genetic propensity. Bacteria are necessary for the disease to appear, but are not sufficient and do not account for all cases of periodontitis. According to one survey in the USA, chronic periodontitis affects approximately 46% of the adult population, with an even higher prevalence among the elderly. This prevalence refers to the cohort of young adults according to the WHO, with ages ranging from 35 to 44 years. Forms of periodontitis that appear at younger ages (before the age of 30 years), and that have other characteristics in addition to age, are known as aggressive periodontitis. The prevalence of this disorder ranges from 0.2% in Caucasians to 2.6% in Afro-Americans. The microbiota of the human oral mucosa together with other anatomical locations in the body constitute the human microbiome. The equilibrium between these organisms and the host response plays a fundamental role in human biology, both in health maintenance and in the appearance of disease. Unfavorable alterations in the composition of the microbiota are termed dysbiosis.
Antiseptics and antibiotics such as Chlorhexidine or Metronidazole, are delivered locally as an adjunct to scaling and root planing procedures, in order to eradicate the subgingival microbes, hence creating a healthy subgingival environment. However, the results presented in the literature are inconclusive. There is a need for further clinical trials with strict methodological criteria for allowing a more precise assessment of the efficacy of local antimicrobials in the treatment of chronic periodontitis.
Recently, there has been renewed interest in the application of natural products. Several natural products and herbs have claimed to have better properties and less side effects than chemical agents for irrigation. The use of natural extracts and essential oils as an irrigation agent for ultrasonic instrumentation has shown to promote slight adjunctive effect compared to chlorhexidine or water. In other study, natural extract showed a greater improvement compared to controls in patients with a more severe degree of periodontitis. However, in other studies this pocket reduction and clinical attachment gain were no significant when compared to water. Natural products have also been tested in forms of oral spray, and have shown to be effective against common oral pathogens without significant cytotoxicity in an in vitro study. Thus, it has the potential to prevent the infections and may serve as adjunctive treatment to conventional therapy. They claim to have the same or even more anti-microbial effect and anti-inflammatory effect without adding any chemicals. But still there is no adequate scientific evidence to support this hypothesis.
This study aims to test the effect as an adjutant to therapy of a nutraceutical composed of several plant extracts in patients with periodontitis and different levels of risk for metabolic syndrome. Specifically:
- The response of periodontal clinical variables to non-surgical periodontal treatment in patients treated with the extract, compared to controls.
- The effect on local inflammatory markers, in patients treated with the extract compared to controls.
- The modifier effect of metabolic syndrome-related variables in the treatment outcomes of the patients treated with the extract compared to controls.
Hypothesis:
The application of the plant extract would act as an anti-inflammatory agent, contributing to better treatment outcomes of periodontitis, in terms of clinical and biochemical variables.
Detailed description
METHODOLOGY
Study design Randomized, controlled, double-blinded clinical trial.
Study unit/population Subjects with diagnosis of periodontitis according to the joint EFP/AAP 2018 criteria for the case definition of periodontitis.
Inclusion criteria Patients attended in the University of Granada School of Dentistry (Granada, Spain) Signing of a written consent.
Exclusion criteria Age under 18 years, received periodontal treatment in the last year, anti-microbial therapy in the previous 3 months, multiple pregnancy and the presence of neoplastic or severe infectious diseases.
Sampling and randomization It is estimated to explore at least 60 patients, of which 30 will be randomized to each group, accordingly to similar studies on the topic available in the literature. The group allocation will also follow similar studies published previously in the field (7-9, 12, 13). All patients will receive standard periodontal treatment with an ultrasonic new generation device (AIRFLOW® Prophylaxis Master, EMS Dental, Nyon, Switzerland), and the group division will be based on the use of the extract as an adjunct to non-surgical treatment.
Test group: Patients that will receive the application of the extract in form of irrigation solutions in the periodontal pockets during regular periodontal treatment. Patients would continue at home during the follow-up period, taking the essential oils in as a rinse twice per day, and as a spray when regular toothbrush could not be performed.
Control group: Patients that will follow the same protocol, but using regular irrigation and a placebo spray at home.
The researchers that will perform the clinical examinations will be blinded for the group allocation of the participants, since the random allocation and prescription will be performed by a different researcher. Study products and placebo will be provided previously by the company BIONAP.
Study variables
- Sociodemographic variables: sex, age, smoking habit (cigs/day), alcohol consumption (g/day).
- Periodontal clinical variables: Periodontal examination will be performed by a calibrated researcher using PCPUNC15 periodontal probe (Hu-friedy, Chicago, IL, USA) and dental exploration mirror. Six surfaces in each implant will be measured: mesiovestibular, vestibular, distovestibular, distolingual, lingual, mesiolingual. All clinical data will be recorded in a periodontal chart. Clinical data will be gathered at baseline, and at 2 and 6 months of follow-up. Bleeding on probing: The percentage of bleeding implants while probing, will the registered following the index of Ainamo and Bay (14). Oral hygiene: Oral hygiene will be measured using the Plaque Index proposed by Tonetti (15). The presence of plaque will be registered by visual examination without using a plaque revealing agent.
- Metabolic syndrome-related variables:
- Body weight
- Body height
- Body mass index
- Waist circumference
- Blood pressure
- Biochemical variables:
Samples of saliva, subgingival plaque and gingival crevicular fluid will be obtained at the beginning of the study, at 2 months and at the end of follow-up. A panel of inflammatory cytokines will be assessed.
Blood samples will be obtained at the beginning of the study, at 2 months and at the end of follow-up for the assessment of:
- Fasting blood glucose
- Lipid profile (Total cholesterol, Triglycerides, LDL-cholesterol and HDL-cholesterol).
Data management and statistical analysis A database in Excel format will be prepared including all recorded variables. The data will be analyzed by a single researcher. The statistical software SPSS v.21.0 (IBM Inc., Chicago, IL, USA) will be used, performing descriptive statistics (means, standard deviations and percentages) and analytical procedures (95% confidence intervals, Mann-Whitney test, Chi-square, Student's t-test for paired samples, and univariate and multivariate regression analysis). A 5% significance level will be considered for all tests.
ETHICAL CONSIDERATIONS The study will be designed in order to comply with the standards of the las revision of the Helsinki declaration. Approval from the Research Ethics Committee in Human Studies of the University of Granada will be obtained prior to the beginning of the study. Written informed consent will be obtained from all participants in the study. All obtained data will be anonymous and the study will be designed following the CONSORT guidelines for reporting clinical trials (16).
WORK PLAN
The project has been planned to be performed in a period of 2 years:
- Study registration, ethical approval, and planning: December 2018 - February 2019.
- Study enrollment, allocation, samples and data gathering. Follow-up period: March 2019 - April 2020.
- Statistical analysis of all data: June 2020 - September 2020.
- Manuscript preparation and publication process: October 2020 - April 2021.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Other: Plant-based oral rinsePatients that will receive the application of the extract in form of irrigation solutions in the periodontal pockets during regular periodontal treatment. Patients would continue at home during the follow-up period, taking the essential oils in as a rinse twice per day, and as a spray when regular toothbrush could not be performed. |
| Control Group | Placebo comparator | Other: Placebo oral rinsePatients that will follow the same protocol, but using placebo irrigation and a placebo spray at home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients attended in the University of Granada School of Dentistry (Granada, Spain)
- Accepting to be enrolled in the study and signing of a written consent.
Key exclusion criteria (6 listed)
- Age under 18 years,
- Received periodontal treatment in the last year,
- Anti-microbial therapy in the previous 3 months
- Allergies
- Multiple pregnancy
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 |
|---|---|---|
| Plant-based oral rinseOral rinse enriched with plant-based essential oils. | Other | Test Group |
| Placebo oral rinseOral rinse with the exact characteristics in terms of colour and odour of the plant-based one, but without the essential oils aimed to test in this study | Other | Control Group |
Primary outcome
Pocket probing depth
Time frame: Change from Baseline Pocket probing depth at 3 months
Depth of periodontal pockets present in the teeth of each patient in millimeters (mm) using a periodontal probe (PCPUNC-15)
Pocket probing depth
Time frame: Change from Baseline Pocket probing depth at 6 months
Depth of periodontal pockets present in the teeth of each patient in millimeters (mm) using a periodontal probe (PCPUNC-15)
Gingival recession
Time frame: Change from Baseline Gingival recession at 3 months
Distance from the gingival margin to the cemento-enamel junction in the teeth of each patient in millimeters (mm) using a periodontal probe (PCPUNC-15)
Gingival recession
Time frame: Change from Baseline Gingival recession at 6 months
Distance from the gingival margin to the cemento-enamel junction in the teeth of each patient in millimeters (mm) using a periodontal probe (PCPUNC-15)
Bleeding on probing
Time frame: Change from Baseline Bleeding on probing at 3 months
Percentage of teeth (%) that showed bleeding during periodontal examination.
Bleeding on probing
Time frame: Change from Baseline Bleeding on probing at 6 months
Percentage of teeth (%) that showed bleeding during periodontal examination.
Oral hygiene
Time frame: Change from Baseline Visual Plaque Index at 3 months
Percentage of teeth surfaces (4 in each tooth) that showed visible plaque during periodontal examination (Visual Plaque Index).
Oral hygiene
Time frame: Change from Baseline Visual Plaque Index at 6 months
Percentage of teeth surfaces (4 in each tooth) that showed visible plaque during periodontal examination (Visual Plaque Index).
15 secondary outcomes
Body weight
Time frame: Change from Baseline Body weight at 3 months
Body weight
Time frame: Change from Baseline Body weight at 6 months
Body height
Time frame: Baseline
Waist circumference
Time frame: Change from Baseline Waist circumference at 3 months
Waist circumference
Time frame: Change from Baseline Waist circumference at 6 months
Systolic Blood pressure
Time frame: Change from Baseline Systolic Blood pressure at 3 months
Systolic Blood pressure
Time frame: Change from Baseline Systolic Blood pressure at 6 months
Diastolic Blood pressure
Time frame: Change from Baseline Diastolic Blood pressure at 3 months
Diastolic Blood pressure
Time frame: Change from Baseline Diastolic Blood pressure at 6 months
Glycemia
Time frame: Change from Baseline Glycemia at 3 months
Glycemia
Time frame: Change from Baseline Glycemia at 6 months
Total cholesterol
Time frame: Change from Baseline Total cholesterol at 6 months
Triglyceride
Time frame: Change from Baseline Triglyceride at 6 months
LDL-cholesterol
Time frame: Change from Baseline LDL-cholesterol at 6 months
HDL-cholesterol
Time frame: Change from Baseline HDL-cholesterol at 6 months
Results and safety
The study was stopped early (reason given: Due to COVID-19 Pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
- 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.
Francisco Mesa, PhD principal investigator
Full Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant-based oral rinse in people with Periodontitis, run by Universidad de Granada at 1 site in Spain.
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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 31 Dec 2020. 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 Spain. 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.
Are results available for this study?
The study was stopped early (reason given: Due to COVID-19 Pandemic). Results are not available in the source record.
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?
Pocket probing depth (time frame: Change from Baseline Pocket probing depth at 3 months). The study lists 8 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 31 Dec 2020.