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Completed

NCT Number: NCT05803109

Efficacy of Coconut Oil With Peppermint Essential for Oral Hygiene Routine

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.

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry Cairo University

Cairo, Kasr El Ainy, 12613, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AVIVA-PURE-CocoPull-Organic-made in USA

Other

virgin cold pressed coconut oil with Peppermint essential oil

Primary outcomes

  1. 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

  2. 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)

  3. 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)

  4. 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)

Secondary outcomes

  1. Change in the Bacterial virulence will be assessed

    Time frame: T0: Baseline. T1: After one month. T2: After three months

    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)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 7, 2023
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.