An interventional study of AVIVA-PURE-CocoPull-Organic-made in USA in Fluoride Adverse Reaction, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-11.
Sponsored by Cairo University · Not applicable, Interventional, and Prevention
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.
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.
Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: T0: Baseline. T1: After one month. T2: After three months
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)
Time frame: T0: Baseline. T1: After one month. T2: After three months
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Cairo University