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Oil Pulling Reduction

11. juli 2026 opdateret af: Bennett Amaechi, The University of Texas Health Science Center at San Antonio

Evaluation of Oil Pulling Mouthwash for Reduction of Dental Plaque, Gingivitis, and Selective Reduction of Bacteria

The goal of this study is to scientifically evaluate the efficacy of this oil pulling oral rinse in reducing dental plaque, gingival inflammation, gingival bleeding, and selectively reducing caries- and periodontal disease-associated bacteria compared to a marketed mouthwash and a placebo oral rinse

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

A total of 120 subjects who met all necessary requirements for selection as subjects will be stratified into three balanced groups (40 per group) according to age, gender, and their mean baseline gingivitis index measured using the Modified Gingival Index (MGI). The three groups will be randomly assigned to use one of three test mouthwashes: GuruNanda Oil Pulling oral rinse (test), Competitor's mouthwash (positive), Water-based oral rinse (placebo). Subjects will be instructed to use their assigned mouthwash as an adjunct oral hygiene product for the 8-week treatment duration. All subjects will be provided with the same brand of toothpaste (non-antimicrobial) and a soft-bristled toothbrush to use for their routine daily toothbrushing for the 8-week treatment duration. All study products will be used according to their manufacturers' instructions. However, to facilitate blinding, only the Randomizer will dispense the products, give instructions on the use of the products, and supervise the first use of the product at the clinical facility. The clinical Examiner and other study team members will not discuss product-use with the subjects. All mouthwash will be used once daily before bed at night, while toothbrushing will be performed twice daily in the morning and before bed at night. For each test subject, assessment data will be collected at baseline, 4 weeks, and 8 weeks. Data will be collected on gingival inflammation, gingival bleeding, and dental plaque, using Modified Gingival Index (MGI), Gingival Bleeding Index (GBI), and Rustogi Modification of the Navy Plaque Index (RMNPI), respectively. The average summary scores will be calculated for each group on each of these indices. Supragingival plaque samples will be collected for plaque microbiome analysis at baseline, 4 weeks, and 8 weeks. All dental examinations for data collection in all 120 subjects will be conducted by the same Clinical Examiner throughout the study. Subjects will be examined and queried on adverse events at each study visit.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

120

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Bennett T Amaechi, BDS, MS, PhD, MFDS RCPS, FADI
  • Telefonnummer: 210-567-3185
  • E-mail: amaechi@uthscsa.edu

Studiesteder

  • Forenede Stater
    • Texas
      • San Antonio, Texas, Forenede Stater, 78229
        • Rekruttering
        • Clinical Research Facility of the Center for Oral Health and Research, UTHSA
        • Kontakt:
          • Bennett T Amaechi, BDS, MS, PhD, MFDS RCPS, FADI
          • Telefonnummer: 210-567-3185
          • E-mail: amaechi@uthscsa.edu
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Adult subjects aged 18-70, that are in good health.

  2. Subject must have:

    1. Baseline gingival inflammation (MGI) score of at least 1.80.
    2. Baseline gingival bleeding (GBI) score of ≥ 1 on at least 20 sites.
  3. An overnight (12 to 18 hour abstention from any oral hygiene) dental plaque (mean) score greater than 0.6 according to the RMNPI Index.
  4. Have a minimum of 20 'scorable' teeth (excluding 3rd molars).
  5. The subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side effects. Subjects will sign the Informed Consent Form.
  6. The subjects should be willing to comply with the study procedure and schedule, including the follow-up visits.

Exclusion Criteria:

  1. Current or history of oral cavity cancer or oropharyngeal cancer.
  2. Subject with destructive periodontal disease or those on antibiotic or anti-inflammatory drugs.
  3. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
  4. Pregnant or nursing by subject report.
  5. Known allergic reaction to any of the study mouthwashes or any of their component.
  6. Any active condition, including but not limited to advanced periodontal disease or severe gingival recession, in the oral cavity at the discretion of the investigator.
  7. Any surgery or recent dental procedure in the oral cavity within 3 months prior to treatment, or before complete healing.
  8. Subjects that do not brush regularly.
  9. Any condition that might make it unsafe for the subject to participate in this study, at the discretion of the investigator.
  10. History of allergy or hypersensitivity to mouthwash ingredients
  11. Significant medical conditions, such as uncontrolled diabetes or immunosuppressive disorders
  12. Use of tobacco products, including cigarettes and smokeless tobacco
  13. Presence of orthodontic appliances, except for removable retainers
  14. Participation in another clinical trial within the last 30 days.
  15. Individuals unable to comply with study requirements, such as regular product use or scheduled visits.
  16. Habitual use of alcohol or drugs that may affect compliance or oral health

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Positiv kontrol
Kosttilskud: TheraBreath Plaque Control Oral Rinse
negative control
Eksperimentel: Testprodukt
Kosttilskud: GuruNanda natural Oil Pulling oral rinse
test product
Placebo komparator: Negative Control
Kosttilskud: GuruNanda water-based non-whitening mouthwash
negative control

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Modified Gingival Index (MGI)
Tidsramme: Baseline to 8 weeks

The gingiva will be segmented into 6 sites per tooth (distobuccal, buccal, mesiobuccal and distolingual, lingual, mesiolingual surfaces). Gingival inflammation will be recorded at each tooth site on a scale of 0 to 4:

Gingivitis will be assessed by the Modified Gingival Index on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth:

0 - Normal (absence of inflammation)

  1. - Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit
  2. - Mild inflammation of the entire gingival unit
  3. - Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit
  4. - Severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit.
Baseline to 8 weeks
Gingival Bleeding Index (GBI)
Tidsramme: Baseline to 8 weeks

A full mouth bleeding assessment will be performed based on the Gingival Bleeding Index. The gingiva should be gently dried and lightly swept with a 0.5 diameter periodontal probe (to be used for each subject for all visits). The probe will be engaged approximately 1 millimeter (mm) into the gingival crevice at an angle to the tooth. A moderate pressure will be used while sweeping from interproximal to interproximal along the sulcular epithelium. The gingiva will be segmented into 6 sites per tooth (distobuccal, buccal, mesiobuccal and distolingual, lingual, mesiolingual surfaces). Bleeding or the absence of bleeding will be assessed at each tooth site on a scale of 0 to 3. Subjects with less than 20 bleedings sites at Visit 1 will be dismissed from the study.

The GBI Scoring System to be used is as follows:

0 - No bleeding after 30 seconds

  1. - Bleeding upon probing after 30 seconds
  2. - Immediate bleeding observed
Baseline to 8 weeks
Rustogi Modified Navy Plaque Index (RMNPI)
Tidsramme: Baseline to 8 weeks
Plaque examinations will be performed using the Rustogi Modified Navy Plaque Index (RMNPI)1. Subjects' will swish with 5 mls of a disclosing solution for 10 seconds and expectorate followed by 10 mls of water for 10 seconds. After disclosing, the plaque on each tooth will be evaluated as present (1) or absent (0).
Baseline to 8 weeks
Measurement of plaque microbiome analysis
Tidsramme: Baseline to 8 weeks
Supragingival plaque samples will be collected from molar and pre-molar teeth region using the sterile curettes. To minimize contamination, subjects will avoid eating; drinking (except water) and oral hygiene practices for one hour before collection. Samples will be transferred immediately into sterile DNA preserving micro-centrifuge tubes and stored at -80 until analysis.
Baseline to 8 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Satisfaction Questionnaire
Tidsramme: 8 weeks
A questionnaire containing 11 items: 6 with a potential score of (a) 5=Very High to (e)1=Very Low and 5 free response questions. Total scores range from 6-30 with a higher score indicating greater satisfaction
8 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The University of Texas Health Science Center at San Antonio

Samarbejdspartnere

GuruNanda LLC

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

31. oktober 2026

Studieafslutning (Anslået)

31. oktober 2026

Datoer for studieregistrering

Først indsendt

11. juli 2026

Først indsendt, der opfyldte QC-kriterier

11. juli 2026

Først opslået (Faktiske)

16. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STUDY00001243

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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