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Virgin Coconut Oil Versus Chlorhexidine Mouthwash in Non-Surgical Periodontal Therapy of Periodontitis Patients. A Randomized Controlled Clinical Trial With Biochemical Assessment.

11. juli 2026 opdateret af: Ain Shams University
This randomized controlled clinical trial will evaluate the effect of virgin coconut oil mouthwash compared with chlorhexidine mouthwash as an adjunct to non-surgical periodontal therapy in patients with stage II periodontitis. Participants will receive scaling and root planing, followed by the assigned mouthwash for 30 days. Clinical periodontal parameters, including plaque index, gingival index, bleeding on probing, probing pocket depth, and clinical attachment level, will be recorded. Gingival crevicular fluid samples will also be collected to assess tumor necrosis factor-alpha levels before and after mouthwash use. The study aims to compare the clinical and biochemical effects of the two mouthwashes.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

42

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Yasmine El-Sayed Fouad, Ass.Lecture
  • Telefonnummer: +201005793929

Studiesteder

  • Egypten
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypten, 11566
        • Faculty of Dentistry,Ain Shams University
        • 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

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • 1. Both genders. 2. Age (30-50) years old. 3. Systemically free according to the modified Burkett's health history questionnaire .

    4. Generalized Periodontitis Stage II . 5. Having at least 20 tooth excluding wisdoms. 6. No history of dental visit in past three months. 7. Participants willing to commit for the entire period of the trial and agreed to sign the written consent after full explanation of the study.

Exclusion Criteria:

  • 1. Smokers. 2. Status of Pregnancy or Contraceptives usage. 3. Allergy to coconut oil . 4. Previous Periodontal treatment within the last 6 months. 5. Antibiotic and/or Anti-inflammatory therapy within the last 6 months.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Chlorhexidine mouthwash group.
Patients with Stage II periodontitis will receive non-surgical periodontal therapy followed by chlorhexidine mouthwash according to the study protocol.
Procedure: Non-surgical periodontal therapy
Full-mouth supra- and subgingival scaling and root planing will be performed as part of phase I periodontal therapy.
Andet: Chlorhexidine mouthwash
Chlorhexidine mouthwash will be used as an adjunct to non-surgical periodontal therapy according to the assigned treatment protocol.
Eksperimentel: Virgin coconut oil mouthwash group.
Patients with Stage II periodontitis will receive non-surgical periodontal therapy followed by virgin coconut oil mouthwash according to the study protocol.
Procedure: Non-surgical periodontal therapy
Full-mouth supra- and subgingival scaling and root planing will be performed as part of phase I periodontal therapy.
Andet: Virgin coconut oil mouthwash
Virgin coconut oil mouthwash will be used as an adjunct to non-surgical periodontal therapy according to the assigned treatment protocol.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Clinical attachment level(CAL)
Tidsramme: From baseline (48 hours after non-surgical periodontal therapy) to 4 weeks after mouthwash use.
Clinical attachment level (CAL) will be measured in millimeters from the cementoenamel junction to the base of the periodontal pocket using a manual Michigan O periodontal probe with Williams markings. Measurements will be recorded at six sites per tooth for all teeth, excluding third molars. The mean CAL value will be calculated and recorded for each patient.
From baseline (48 hours after non-surgical periodontal therapy) to 4 weeks after mouthwash use.
Periodontal pocket depth(PPD)
Tidsramme: From baseline (48 hours after non-surgical periodontal therapy) to 4 weeks after mouthwash use
Periodontal pocket depth (PPD) will be measured in millimeters from the gingival margin to the base of the periodontal pocket using a manual Michigan O periodontal probe with Williams markings. Measurements will be recorded at six sites per tooth for all teeth, excluding third molars. The mean PPD value will be calculated and recorded for each patient.
From baseline (48 hours after non-surgical periodontal therapy) to 4 weeks after mouthwash use
Plaque Index(PI)
Tidsramme: From baseline (48 hours after non-surgical periodontal therapy) to 4 weeks after mouthwash use
Plaque index (PI) will be assessed on the buccal and lingual surfaces of all teeth using a standardized 0-3 clinical scoring system. The mean PI score will be calculated and recorded for each patient. Surfaces with PI scores of 1, 2, or 3 will also be considered plaque-positive, and the percentage of plaque-positive surfaces will be calculated.
From baseline (48 hours after non-surgical periodontal therapy) to 4 weeks after mouthwash use
Gingival index(GI)
Tidsramme: From baseline (48 hours after non-surgical periodontal therapy) to 4 weeks after mouthwash use
Gingival index (GI) will be assessed on the buccal and lingual surfaces of all teeth using a standardized 0-3 clinical scoring system. The mean GI score will be calculated and recorded for each patient. Surfaces with GI scores of 1, 2, or 3 will also be considered inflammation-positive, and the percentage of inflammation-positive surfaces will be calculated.
From baseline (48 hours after non-surgical periodontal therapy) to 4 weeks after mouthwash use
Sulcus bleeding index (SBI)
Tidsramme: From baseline (48 hours after non-surgical periodontal therapy) to 4 weeks after mouthwash use
Sulcus bleeding index (SBI) will be assessed after gentle probing of the gingival sulcus using a standardized 0-3 clinical scoring system. The mean SBI score will be calculated and recorded for each patient. Sites with SBI scores of 1, 2, or 3 will also be considered bleeding-positive, and the percentage of bleeding-positive sites will be calculated.
From baseline (48 hours after non-surgical periodontal therapy) to 4 weeks after mouthwash use

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in gingival crevicular fluid TNF-alpha level
Tidsramme: From baseline (48 hours after non-surgical periodontal therapy) to 4 weeks after mouthwash use
Tumor necrosis factor-alpha (TNF-alpha) level will be measured in gingival crevicular fluid (GCF) samples collected using sterile perio paper strips. Samples will be analyzed using enzyme-linked immunosorbent assay (ELISA), and TNF-alpha concentration will be recorded for each patient.
From baseline (48 hours after non-surgical periodontal therapy) to 4 weeks after mouthwash use
Patient satisfaction regarding mouthwash-related side effects
Tidsramme: At 4 weeks after mouthwash use.
Patient satisfaction regarding mouthwash-related side effects will be assessed using a patient questionnaire and clinical inspection after mouthwash use. The assessment will include taste alteration, tooth staining, supragingival calculus accumulation, and overall satisfaction with mouthwash use. Responses and clinical findings will be recorded and summarized for each patient
At 4 weeks after mouthwash use.

Samarbejdspartnere og efterforskere

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

Sponsor

Ain Shams University

Efterforskere

  • Studieleder: Ahmed Amr, Professor, Faculty of dentistry-Ain Shams University

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)

1. august 2026

Studieafslutning (Anslået)

1. august 2026

Datoer for studieregistrering

Først indsendt

11. juli 2026

Først indsendt, der opfyldte QC-kriterier

11. juli 2026

Først opslået (Faktiske)

15. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. 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

  • FDASU-RecIM012386

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be shared. Only aggregated and de-identified results will be reported in the thesis and any related publications. Individual-level data will be kept confidential and accessible only to the study investigators, according to the informed consent and institutional ethics approval.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Stage II Periodontitis

Kliniske forsøg med Non-surgical periodontal therapy

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