Efficacy of Coconut Oil With Peppermint Essential for Oral Hygiene Routine

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.

Study Overview

• Status: Completed
• Conditions: Fluoride Adverse Reaction
• Intervention / Treatment: Other: AVIVA-PURE-CocoPull-Organic-made in USA

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Kasr El Ainy
    • Cairo, Kasr El Ainy, Egypt, 12613
      • Faculty of Dentistry Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: virgin cold-pressed coconut oil with Peppermint essential oil; 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.	Other: AVIVA-PURE-CocoPull-Organic-made in USA; virgin cold pressed coconut oil with Peppermint essential oil
Active Comparator: The fluoride toothpaste (Colgate Total,; 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.	Other: AVIVA-PURE-CocoPull-Organic-made in USA; virgin cold pressed coconut oil with Peppermint essential oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	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)	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)	T0: Baseline. T1: After one month. T2: After three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	T0: Baseline. T1: After one month. T2: After three months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2024
• Primary Completion (Actual): January 1, 2025
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: January 28, 2023
• First Submitted That Met QC Criteria: March 26, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): May 11, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: CairoU 4 7 22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No