Clinical trial NCT05803109: Efficacy of Coconut Oil With Peppermint Essential for Oral Hygiene Routine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fluoride Adverse Reaction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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
* Patients have brushing habits
* No Fixed orthodontic treatment
* No active or untreated caries
* Patients on non-cariogenic diet

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Change in the actual chance to avoid new lesion will be assessed
timeFrame: T0: Baseline. T1: After one month. T2: After three months
measure: Change in the bacterial count will be assessed
timeFrame: T0: Baseline. T1: After one month. T2: After three months
measure: Change in the salivary pH will be assessed
timeFrame: T0: Baseline. T1: After one month. T2: After three months
measure: Change in the Plaque index will be assessed Löe-Silness (Loe 1963)
timeFrame: T0: Baseline. T1: After one month. T2: After three months
Secondary outcomes:
measure: Change in the Bacterial virulence will be assessed
timeFrame: T0: Baseline. T1: After one month. T2: After three months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry Cairo University
state: Kasr El Ainy
Study officials:
References: