Fluoride Adverse ReactionNCT05803109
Efficacy of Coconut Oil With Peppermint Essential for Oral Hygiene Routine
A study testing AVIVA-PURE-CocoPull-Organic-made in USA in people with Fluoride Adverse Reaction, run by Cairo University at 1 site in Egypt.
Trial summary
This randomized clinical trial will be conducted to investigate the efficacy of an innovative tooth cleaning agent extra virgin coconut oil with peppermint essential oil by oil pulling and toothbrushing with oil on reducing salivary Streptococcus mutans levels, tooth decay and plaque buildup versus on the counter… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Fluoride Adverse Reaction
- What is being tested?
- AVIVA-PURE-CocoPull-Organic-made in USA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Aug 2024to 1 Jan 2025
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients will be recruited in this study, will be medically free.
- Age range 20-50 years
- Patients with high caries risk assessment (0- 30% high caries risk) according to Cariogram - a multifactorial risk assessment model for dental caries.
- Non-Smoking patients
- Not under antibiotic therapy either at the time of the study or up to the last month before the start of the study.
- Male or Female patients
Show all 10Show fewer
- Patients have brushing habits
- No Fixed orthodontic treatment
- No active or untreated caries
- Patients on non-cariogenic diet
Who cannot join
- Patients with a compromised medical history.
- Patients with low caries risk assessment according to Cariogram - a multifactorial risk assessment model for dental caries.
- Patients with severe or active periodontal disease.
- Patients with a history of allergy to any of the drugs or chemicals will be used in the study.
- Patients on any antibiotics during the past month.
- Smoking patient
Show all 12Show fewer
- Patients with very low saliva secretion xerostomia less than 0.5ml stimulated saliva /min score 3 according to Cariogram
- Pregnant female patient
- No brushing habits
- Fixed orthodontic treatment
- Active or untreated caries
- Patients on cariogenic diet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Extra Virgin Cold Pressed Coconut Oil With Peppermint Essential Oil as Natural Cleaning Agent for Oral Hygiene Routine on Salivary Streptococcus Mutant Levels Versus The Conventional Oral Hygiene Methods in High Caries Risk Patients: A Randomized Clinical Trial
This randomized clinical trial will be conducted to investigate the efficacy of an innovative tooth cleaning agent extra virgin coconut oil with peppermint essential oil by oil pulling and toothbrushing with oil on reducing salivary Streptococcus mutans levels, tooth decay and plaque buildup versus on the counter toothpaste in high caries risk patients.
Read the detailed description
Everyday use of dental health care products has increased. Therefore, there is a legitimately increased interest of healthcare clinicians and consumers in substances added to the toothpaste with the intention to improve their performance and potential benefits and risks that may arise from it. As there are harmful products in the toothpaste for instance: (Fluoride, Sodium Lauryl Sulphate (SLS), Sodium Saccharin and Triclosan which is assumed that it because local reaction includes oral mucosa irritation and desquamation (stomatitis, glossitis, gingivitis, buccal mucositis), while systemic ones are allergic and acute or chronic toxic reactions. Rational Harmful products in the toothpaste for instance: (Fluoride, Sodium Lauryl Sulphate (SLS), Sodium Saccharin and Triclosan which is assumed that it because local reaction includes oral mucosa irritation and desquamation (stomatitis, glossitis, gingivitis, buccal mucositis), while systemic ones are allergic and acute or chronic toxic reactions.
- Conditions
- Fluoride Adverse Reaction
- Being tested
- AVIVA-PURE-CocoPull-Organic-made in USA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVIVA-PURE-CocoPull-Organic-made in USAOther
virgin cold pressed coconut oil with Peppermint essential oil
| Study group | Role | What they receive |
|---|---|---|
| virgin cold-pressed coconut oil with Peppermint essential oil | Experimental | Patients will be instructed to use one packet of the coco pull healthy blend of organic oil (virgin cold pressed coconut oil with Peppermint essential oil)and swish the oil in the mouth and pull it between teeth for 5 minutes then spit out the oil and brush their teeth with the oil for 2 minutes; such a regimen will be repeated twice daily for three months. Receives: Other: AVIVA-PURE-CocoPull-Organic-made in USA |
| The fluoride toothpaste (Colgate Total, | Active comparator | Patients will be instructed to brush their teeth with the fluoride toothpaste (Colgat Total, 1450 ppm) for 2 minutes; such a regimen will be repeated two times daily for three months and use 10 ml of 0.12% chlorhexidine rinse for 1 min/day, 30 min after tooth brushing before going to bed. Receives: Other: AVIVA-PURE-CocoPull-Organic-made in USA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the actual chance to avoid new lesion will be assessed
The Measuring test: Cariogram Model (Karabekiroğlu et al 2017), The Measuring units : Percentage
Measured: T0: Baseline. T1: After one month. T2: After three months
Change in the bacterial count will be assessed
The measuring test:Colony forming unit, The measuring units : Cfu/mm2 (Prabakar et al., 2018)
Measured: T0: Baseline. T1: After one month. T2: After three months
Change in the salivary pH will be assessed
The measuring test: Digital pH meter, The measuring unit : Scoring system, (Sondos et al., 2019) (ordinal)
Measured: T0: Baseline. T1: After one month. T2: After three months
Change in the Plaque index will be assessed Löe-Silness (Loe 1963)
The measuring unit : Plaque index The oral hygiene and plaque amount will be estimated using a mirror and graduated periodontal probe in accordance with Silness and Löe plaque index, which assessed the amount of plaque in the cervical part of the tooth.The Plaque Index System
- (0) No plaque
- (1) A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.
- (2) Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye.
- (3) Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Löe-Silness (Loe 1963) (Sreenivasan et al.,2016), The Measuring units : Scoring system (ordinal)
Measured: T0: Baseline. T1: After one month. T2: After three months
Secondary outcomes (1)
Change in the Bacterial virulence will be assessed
The Measuring test: Streptococcus mutans acidogenicity by Digital pH meter ,the maximum value is 7.2 less than it is bad value (Bedoya-Correa et al., 2021),the measuring units : Scoring system (ordinal)
Measured: T0: Baseline. T1: After one month. T2: After three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start21 Aug 2024
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluoride Adverse ReactionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Mohamed Reda Ahmed Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803109
- Sponsor's protocol ID
- CairoU 4 7 22
- Status last verified
- May 2025
- First submitted
- 28 Jan 2023
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Extra Virgin Cold Pressed Coconut Oil With Peppermint Essential Oil as Natural Cleaning Agent for Oral Hygiene Routine on Salivary Streptococcus Mutant Levels Versus The Conventional Oral Hygiene Methods in High Caries Risk Patients: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05803109
- Acronym / sponsor ID
- CairoU 4 7 22
- Conditions
- Fluoride Adverse Reaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 7 Apr 2023 (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.
This randomized clinical trial will be conducted to investigate the efficacy of an innovative tooth cleaning agent extra virgin coconut oil with peppermint essential oil by oil pulling and toothbrushing with oil on reducing salivary Streptococcus mutans levels, tooth decay and plaque buildup versus on the counter toothpaste in high caries risk patients.
Detailed description
Everyday use of dental health care products has increased. Therefore, there is a legitimately increased interest of healthcare clinicians and consumers in substances added to the toothpaste with the intention to improve their performance and potential benefits and risks that may arise from it. As there are harmful products in the toothpaste for instance: (Fluoride, Sodium Lauryl Sulphate (SLS), Sodium Saccharin and Triclosan which is assumed that it because local reaction includes oral mucosa irritation and desquamation (stomatitis, glossitis, gingivitis, buccal mucositis), while systemic ones are allergic and acute or chronic toxic reactions. Rational Harmful products in the toothpaste for instance: (Fluoride, Sodium Lauryl Sulphate (SLS), Sodium Saccharin and Triclosan which is assumed that it because local reaction includes oral mucosa irritation and desquamation (stomatitis, glossitis, gingivitis, buccal mucositis), while systemic ones are allergic and acute or chronic toxic reactions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| virgin cold-pressed coconut oil with Peppermint essential oil | Experimental | Other: AVIVA-PURE-CocoPull-Organic-made in USAPatients will be instructed to use one packet of the coco pull healthy blend of organic oil (virgin cold pressed coconut oil with Peppermint essential oil)and swish the oil in the mouth and pull it between teeth for 5 minutes then spit out the oil and brush their teeth with the oil for 2 minutes; such a regimen will be repeated twice daily for three months. |
| The fluoride toothpaste (Colgate Total, | Active comparator | Other: AVIVA-PURE-CocoPull-Organic-made in USAPatients will be instructed to brush their teeth with the fluoride toothpaste (Colgat Total, 1450 ppm) for 2 minutes; such a regimen will be repeated two times daily for three months and use 10 ml of 0.12% chlorhexidine rinse for 1 min/day, 30 min after tooth brushing before going to bed. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Patients will be recruited in this study, will be medically free.
- Age range 20-50 years
- Patients with high caries risk assessment (0- 30% high caries risk) according to Cariogram - a multifactorial risk assessment model for dental caries.
- Non-Smoking patients
- Not under antibiotic therapy either at the time of the study or up to the last month before the start of the study.
Key exclusion criteria (12 listed)
- Patients with a compromised medical history.
- Patients with low caries risk assessment according to Cariogram - a multifactorial risk assessment model for dental caries.
- Patients with severe or active periodontal disease.
- Patients with a history of allergy to any of the drugs or chemicals will be used in the study.
- Patients on any antibiotics during the past month.
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 |
|---|---|---|
| AVIVA-PURE-CocoPull-Organic-made in USAvirgin cold pressed coconut oil with Peppermint essential oil | Other | The fluoride toothpaste (Colgate Total,, virgin cold-pressed coconut oil with Peppermint essential oil |
Primary outcome
Change in the actual chance to avoid new lesion will be assessed
Time frame: T0: Baseline. T1: After one month. T2: After three months
The Measuring test: Cariogram Model (Karabekiroğlu et al 2017), The Measuring units : Percentage
Change in the bacterial count will be assessed
Time frame: T0: Baseline. T1: After one month. T2: After three months
The measuring test:Colony forming unit, The measuring units : Cfu/mm2 (Prabakar et al., 2018)
Change in the salivary pH will be assessed
Time frame: T0: Baseline. T1: After one month. T2: After three months
The measuring test: Digital pH meter, The measuring unit : Scoring system, (Sondos et al., 2019) (ordinal)
Change in the Plaque index will be assessed Löe-Silness (Loe 1963)
Time frame: T0: Baseline. T1: After one month. T2: After three months
The measuring unit : Plaque index The oral hygiene and plaque amount will be estimated using a mirror and graduated periodontal probe in accordance with Silness and Löe plaque index, which assessed the amount of plaque in the cervical part of the tooth.The Plaque Index System * (0) No plaque * (1) A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface. * (2) Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye. * (3) Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. Löe-Silness (Loe 1963) (Sreenivasan et al.,2016), The Measuring units : Scoring system (ordinal)
1 secondary outcome
Change in the Bacterial virulence will be assessed
Time frame: T0: Baseline. T1: After one month. T2: After three months
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 11 May 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AVIVA-PURE-CocoPull-Organic-made in USA in people with Fluoride Adverse Reaction, run by Cairo University at 1 site in Egypt.
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 10 inclusion and 12 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 11 May 2025. 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 Egypt. 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?
Change in the actual chance to avoid new lesion will be assessed (time frame: T0: Baseline. T1: After one month. T2: After three months). The study lists 4 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 11 May 2025.